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Challenges and Solutions
for the
Pharmaceutical Industry
Challenges and Solutions
for the
Pharmaceutical Industry
Challenges and Solutions
for the
Pharmaceutical Industry
Table of Contents
Challenges of the pharma industry and solutions
What is the DSCSA?
What is the Impact of DSCSA in the Pharmaceutical Industry?
Deadlines and Serialization for the pharma industry
What is track and trace for pharmaceuticals?
How should a Pharma company plan and prepare?
Pharma
Challenges and Solutions in the Pharmaceutical Industry
The pharmaceutical industry produces life-saving medications for millions of people, making it one of the most important and largest sectors of the global economy. It is one of the most difficult industries to work in, nevertheless, with a lot of challenges to conquer, from regulatory compliance and supply chain management disruptions to pricing structure and data security.
Here are the top challenges facing pharma in 2024 and beyond, and solutions to address these challenges:
The pharmaceutical industry produces life-saving medications for millions of people, making it one of the most important and largest sectors of the global economy. It is one of the most difficult industries to work in, nevertheless, with a lot of challenges to conquer, from regulatory compliance and supply chain management disruptions to pricing structure and data security.
Here are the top challenges facing pharma in 2024 and beyond, and solutions to address these challenges:
The pharmaceutical industry produces life-saving medications for millions of people, making it one of the most important and largest sectors of the global economy. It is one of the most difficult industries to work in, nevertheless, with a lot of challenges to conquer, from regulatory compliance and supply chain management disruptions to pricing structure and data security.
Here are the top challenges facing pharma in 2024 and beyond, and solutions to address these challenges:
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Adherence to Regulations
Pharmaceutical organizations are subject to governmental laws, ranging from those pertaining to clinical trials to standards for manufacture and distribution. It can be difficult to stay on top of these requirements and breaking them can cost you money in fines and harm your reputation. For organizations to maintain operational integrity, regulatory compliance—which entails abiding by local, national, and international rules and regulations—is essential. It includes adhering to legal requirements, quality standards, audit trails, document control, risk management, KPIs, and CAPAs, as well as the FDA and ISO 9001 laws. In addition, the adoption of EPCIS (Electronic Product Code Information Services) plays a critical role in serialization and traceability compliance under DSCSA, enabling standardized data exchange and event tracking across the pharmaceutical supply chain. All businesses, regardless of size, need to abide by these regulations to promote accountability and preserve their competitive edge.
Pharmaceutical organizations are subject to governmental laws, ranging from those pertaining to clinical trials to standards for manufacture and distribution. It can be difficult to stay on top of these requirements and breaking them can cost you money in fines and harm your reputation. For organizations to maintain operational integrity, regulatory compliance—which entails abiding by local, national, and international rules and regulations—is essential. It includes adhering to legal requirements, quality standards, audit trails, document control, risk management, KPIs, and CAPAs, as well as the FDA and ISO 9001 laws. In addition, the adoption of EPCIS (Electronic Product Code Information Services) plays a critical role in serialization and traceability compliance under DSCSA, enabling standardized data exchange and event tracking across the pharmaceutical supply chain. All businesses, regardless of size, need to abide by these regulations to promote accountability and preserve their competitive edge.
Pharmaceutical organizations are subject to governmental laws, ranging from those pertaining to clinical trials to standards for manufacture and distribution. It can be difficult to stay on top of these requirements and breaking them can cost you money in fines and harm your reputation. For organizations to maintain operational integrity, regulatory compliance—which entails abiding by local, national, and international rules and regulations—is essential. It includes adhering to legal requirements, quality standards, audit trails, document control, risk management, KPIs, and CAPAs, as well as the FDA and ISO 9001 laws. In addition, the adoption of EPCIS (Electronic Product Code Information Services) plays a critical role in serialization and traceability compliance under DSCSA, enabling standardized data exchange and event tracking across the pharmaceutical supply chain. All businesses, regardless of size, need to abide by these regulations to promote accountability and preserve their competitive edge.
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Managing Document Requirements
Granting employees access to only the data and systems they need to perform their duties minimizes the potential damage in case of a breach. Implementing role-based access control ensures that even compromised credentials cannot provide attackers with unrestricted access to sensitive information. Regularly reviewing and updating access privileges further strengthens the company’s security posture.
Granting employees access to only the data and systems they need to perform their duties minimizes the potential damage in case of a breach. Implementing role-based access control ensures that even compromised credentials cannot provide attackers with unrestricted access to sensitive information. Regularly reviewing and updating access privileges further strengthens the company’s security posture.
Granting employees access to only the data and systems they need to perform their duties minimizes the potential damage in case of a breach. Implementing role-based access control ensures that even compromised credentials cannot provide attackers with unrestricted access to sensitive information. Regularly reviewing and updating access privileges further strengthens the company’s security posture.
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Have a Compliance Officer Appointed
To navigate the constantly changing regulatory landscape and make wise compliance decisions, a compliance officer’s (CCO) function is essential. Within the company, the CCO promotes ethics, accountability, and corporate integrity. Compliance officers ensure that businesses and organizations follow all applicable laws and industry-specific best practices. They also keep an eye on the bylaws and internal policies. Compliance officers handle issues and provide answers when there are regulatory risks or wrongdoing.
To navigate the constantly changing regulatory landscape and make wise compliance decisions, a compliance officer’s (CCO) function is essential. Within the company, the CCO promotes ethics, accountability, and corporate integrity. Compliance officers ensure that businesses and organizations follow all applicable laws and industry-specific best practices. They also keep an eye on the bylaws and internal policies. Compliance officers handle issues and provide answers when there are regulatory risks or wrongdoing.
To navigate the constantly changing regulatory landscape and make wise compliance decisions, a compliance officer’s (CCO) function is essential. Within the company, the CCO promotes ethics, accountability, and corporate integrity. Compliance officers ensure that businesses and organizations follow all applicable laws and industry-specific best practices. They also keep an eye on the bylaws and internal policies. Compliance officers handle issues and provide answers when there are regulatory risks or wrongdoing.
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Create and Uphold Policies and Guidelines
Creating thorough rules and procedures that handle certain compliance areas found during audits is crucial. These policies must be reviewed and updated on a regular basis to comply with evolving regulatory requirements. To minimize liability, effective policy management involves monitoring employee recognition and comprehension of policies.
Businesses can safeguard resources, reputation, and internal and external stakeholders by implementing an efficient regulatory compliance program that complies with all applicable laws and regulations.
Creating thorough rules and procedures that handle certain compliance areas found during audits is crucial. These policies must be reviewed and updated on a regular basis to comply with evolving regulatory requirements. To minimize liability, effective policy management involves monitoring employee recognition and comprehension of policies.
Businesses can safeguard resources, reputation, and internal and external stakeholders by implementing an efficient regulatory compliance program that complies with all applicable laws and regulations.
Creating thorough rules and procedures that handle certain compliance areas found during audits is crucial. These policies must be reviewed and updated on a regular basis to comply with evolving regulatory requirements. To minimize liability, effective policy management involves monitoring employee recognition and comprehension of policies.
Businesses can safeguard resources, reputation, and internal and external stakeholders by implementing an efficient regulatory compliance program that complies with all applicable laws and regulations.
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Research and Development Expenses
The process of developing new drugs and treatments is expensive and time-consuming. Pharmaceutical companies must be able to reduce research and development (R&D) costs while meeting the need for results by making the most of their resources and streamlining their research procedures.
The pharmaceutical sector invested $83 billion in research and development in 2019. That sum, after accounting for inflation, is roughly ten times the annual expenditure of the industry in the 1980s. The revenue that pharmaceutical companies anticipate from a new drug, the anticipated cost of creating that drug, and the policies that impact the supply and demand for drugs all play a role in how much money they allocate to research and development.
Three primary factors influence the R&D spending decisions of pharmaceutical companies:
Projected lifetime worldwide sales of a novel medication
A new drug’s anticipated development costs
The policies and initiatives that affect the availability and demand for prescription pharmaceuticals.
The process of developing new drugs and treatments is expensive and time-consuming. Pharmaceutical companies must be able to reduce research and development (R&D) costs while meeting the need for results by making the most of their resources and streamlining their research procedures.
The pharmaceutical sector invested $83 billion in research and development in 2019. That sum, after accounting for inflation, is roughly ten times the annual expenditure of the industry in the 1980s. The revenue that pharmaceutical companies anticipate from a new drug, the anticipated cost of creating that drug, and the policies that impact the supply and demand for drugs all play a role in how much money they allocate to research and development.
Three primary factors influence the R&D spending decisions of pharmaceutical companies:
Projected lifetime worldwide sales of a novel medication
A new drug’s anticipated development costs
The policies and initiatives that affect the availability and demand for prescription pharmaceuticals.
The process of developing new drugs and treatments is expensive and time-consuming. Pharmaceutical companies must be able to reduce research and development (R&D) costs while meeting the need for results by making the most of their resources and streamlining their research procedures.
The pharmaceutical sector invested $83 billion in research and development in 2019. That sum, after accounting for inflation, is roughly ten times the annual expenditure of the industry in the 1980s. The revenue that pharmaceutical companies anticipate from a new drug, the anticipated cost of creating that drug, and the policies that impact the supply and demand for drugs all play a role in how much money they allocate to research and development.
Three primary factors influence the R&D spending decisions of pharmaceutical companies:
Projected lifetime worldwide sales of a novel medication
A new drug’s anticipated development costs
The policies and initiatives that affect the availability and demand for prescription pharmaceuticals.
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Pricing Pressure
Pharmaceutical companies are coming under increasing pressure from both government agencies and consumers to limit the price of their products. This pressure could make it harder for companies to invest in R&D and introduce new products, which could potentially lead to lower profit margins and more competition.
The process of creating new medications is expensive and unpredictable, and many of these medications never reach the market. The FDA eventually approves approximately 12% of medications that begin clinical trials for introduction. The typical R&D cost for a new medicine has been estimated in recent studies to range from less than $1 billion to more than $2 billion. These estimates cover costs associated with laboratory research and clinical trials of new drugs that prove successful, as well as costs associated with drugs that fail in the laboratory, enter clinical trials but are withdrawn by the drugmaker for commercial reasons, or are not approved by the FDA. Included in those projections are the business’s capital expenses—the worth of additional lost investments made while conducting research and development. These expenses may account for a sizable portion of the typical overall cost of creating a new medication. The drug’s development process frequently takes 10 years or longer, and during that time the corporation does not get paid for the money it invested in creating the medication.
Pharmaceutical companies are coming under increasing pressure from both government agencies and consumers to limit the price of their products. This pressure could make it harder for companies to invest in R&D and introduce new products, which could potentially lead to lower profit margins and more competition.
The process of creating new medications is expensive and unpredictable, and many of these medications never reach the market. The FDA eventually approves approximately 12% of medications that begin clinical trials for introduction. The typical R&D cost for a new medicine has been estimated in recent studies to range from less than $1 billion to more than $2 billion. These estimates cover costs associated with laboratory research and clinical trials of new drugs that prove successful, as well as costs associated with drugs that fail in the laboratory, enter clinical trials but are withdrawn by the drugmaker for commercial reasons, or are not approved by the FDA. Included in those projections are the business’s capital expenses—the worth of additional lost investments made while conducting research and development. These expenses may account for a sizable portion of the typical overall cost of creating a new medication. The drug’s development process frequently takes 10 years or longer, and during that time the corporation does not get paid for the money it invested in creating the medication.
Pharmaceutical companies are coming under increasing pressure from both government agencies and consumers to limit the price of their products. This pressure could make it harder for companies to invest in R&D and introduce new products, which could potentially lead to lower profit margins and more competition.
The process of creating new medications is expensive and unpredictable, and many of these medications never reach the market. The FDA eventually approves approximately 12% of medications that begin clinical trials for introduction. The typical R&D cost for a new medicine has been estimated in recent studies to range from less than $1 billion to more than $2 billion. These estimates cover costs associated with laboratory research and clinical trials of new drugs that prove successful, as well as costs associated with drugs that fail in the laboratory, enter clinical trials but are withdrawn by the drugmaker for commercial reasons, or are not approved by the FDA. Included in those projections are the business’s capital expenses—the worth of additional lost investments made while conducting research and development. These expenses may account for a sizable portion of the typical overall cost of creating a new medication. The drug’s development process frequently takes 10 years or longer, and during that time the corporation does not get paid for the money it invested in creating the medication.
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Supply Chain Management
The production, distribution, and transportation of medications involve multiple partners, which contributes to the complexity and strict regulation of the pharmaceutical supply chain. Ensuring the quality and safety of pharmaceutical products along the whole supply chain is a critical but challenging task.
The pharmaceutical industry’s supply chain is set up to boost revenue and improve customer satisfaction by guaranteeing that goods can be produced on schedule and promptly delivered to pharmacies, hospitals, and other healthcare facilities when required. Product creation, marketing, operations, distribution, financing, and customer service are, in short, the roles that supply chains play.
The pharmaceutical supply chain is currently dealing with a growing number of layers of complexity. Furthermore, business models have evolved dramatically in recent years, with a shift toward results-oriented models that prioritize integrated diagnostic and treatment solutions. To establish a supply flow that guarantees that the appropriate drug or device is delivered to the correct location, at the right time, and to the right person, effective supply chain management is crucial.
The production, distribution, and transportation of medications involve multiple partners, which contributes to the complexity and strict regulation of the pharmaceutical supply chain. Ensuring the quality and safety of pharmaceutical products along the whole supply chain is a critical but challenging task.
The pharmaceutical industry’s supply chain is set up to boost revenue and improve customer satisfaction by guaranteeing that goods can be produced on schedule and promptly delivered to pharmacies, hospitals, and other healthcare facilities when required. Product creation, marketing, operations, distribution, financing, and customer service are, in short, the roles that supply chains play.
The pharmaceutical supply chain is currently dealing with a growing number of layers of complexity. Furthermore, business models have evolved dramatically in recent years, with a shift toward results-oriented models that prioritize integrated diagnostic and treatment solutions. To establish a supply flow that guarantees that the appropriate drug or device is delivered to the correct location, at the right time, and to the right person, effective supply chain management is crucial.
The production, distribution, and transportation of medications involve multiple partners, which contributes to the complexity and strict regulation of the pharmaceutical supply chain. Ensuring the quality and safety of pharmaceutical products along the whole supply chain is a critical but challenging task.
The pharmaceutical industry’s supply chain is set up to boost revenue and improve customer satisfaction by guaranteeing that goods can be produced on schedule and promptly delivered to pharmacies, hospitals, and other healthcare facilities when required. Product creation, marketing, operations, distribution, financing, and customer service are, in short, the roles that supply chains play.
The pharmaceutical supply chain is currently dealing with a growing number of layers of complexity. Furthermore, business models have evolved dramatically in recent years, with a shift toward results-oriented models that prioritize integrated diagnostic and treatment solutions. To establish a supply flow that guarantees that the appropriate drug or device is delivered to the correct location, at the right time, and to the right person, effective supply chain management is crucial.
Four Components Make Up Traditional Supply Chain Management Systems:
Planning
The process includes planning a product from raw materials to the consumer, including all resources needed to meet customer demands for a company’s product or service. Metrics must be established after the supply chain is in place to assess if it is meeting corporate objectives, providing value to customers, and running successfully and efficiently.
Procurement
Choosing vendors to provide the products and services required for manufacturing is part of the process. Establishing procedures for overseeing and maintaining supplier relationships is the next stage. Ordering, receiving, keeping track of inventories, and approving supplier payments are important procedures.
Production
Choosing vendors to provide the products and services required for manufacturing is part of the process. Establishing procedures for overseeing and maintaining supplier relationships is the next stage. Ordering, receiving, keeping track of inventories, and approving supplier payments are important procedures.
Delivery and logistics
Order management, delivery scheduling, shipping execution, client billing, and payment collection are all included in the process.
Planning
The process includes planning a product from raw materials to the consumer, including all resources needed to meet customer demands for a company’s product or service. Metrics must be established after the supply chain is in place to assess if it is meeting corporate objectives, providing value to customers, and running successfully and efficiently.
Procurement
Choosing vendors to provide the products and services required for manufacturing is part of the process. Establishing procedures for overseeing and maintaining supplier relationships is the next stage. Ordering, receiving, keeping track of inventories, and approving supplier payments are important procedures.
Production
Choosing vendors to provide the products and services required for manufacturing is part of the process. Establishing procedures for overseeing and maintaining supplier relationships is the next stage. Ordering, receiving, keeping track of inventories, and approving supplier payments are important procedures.
Delivery and logistics
Order management, delivery scheduling, shipping execution, client billing, and payment collection are all included in the process.
Planning
The process includes planning a product from raw materials to the consumer, including all resources needed to meet customer demands for a company’s product or service. Metrics must be established after the supply chain is in place to assess if it is meeting corporate objectives, providing value to customers, and running successfully and efficiently.
Procurement
Choosing vendors to provide the products and services required for manufacturing is part of the process. Establishing procedures for overseeing and maintaining supplier relationships is the next stage. Ordering, receiving, keeping track of inventories, and approving supplier payments are important procedures.
Production
Choosing vendors to provide the products and services required for manufacturing is part of the process. Establishing procedures for overseeing and maintaining supplier relationships is the next stage. Ordering, receiving, keeping track of inventories, and approving supplier payments are important procedures.
Delivery and logistics
Order management, delivery scheduling, shipping execution, client billing, and payment collection are all included in the process.
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Data Security
Large volumes of sensitive data, including patient information and data from clinical trials, are gathered and stored by pharmaceutical corporations. It can be difficult to ensure the security and integrity of this data in the age of cyberattacks and data breaches, but it is essential. The pharmaceutical and healthcare industries have a lot in common. Pharma’s network architecture not only houses patient data but also company private data, including drug patent intellectual property, clinical trial findings, IoT and OT device manufacturing data, and research subject data. Attacks on the sector could destroy patient prescription records or interfere with critical research.
The pharmaceutical sector has been using AI in automation and security technologies; 40% of businesses claim to employ the technology actively. AI is a very helpful security technique in IoT and OT contexts in the pharmaceutical industry.
The pharmaceutical industry will likely be leaders in the use of automation and artificial intelligence (AI), particularly in the development of generative AI used to analyze data more effectively for anomalies and detect intruders in the network. Other security practices, such as utilizing systems to protect hybrid and multi-cloud environments to build security into software and hardware development, are still essential components of any cybersecurity program.
Large volumes of sensitive data, including patient information and data from clinical trials, are gathered and stored by pharmaceutical corporations. It can be difficult to ensure the security and integrity of this data in the age of cyberattacks and data breaches, but it is essential. The pharmaceutical and healthcare industries have a lot in common. Pharma’s network architecture not only houses patient data but also company private data, including drug patent intellectual property, clinical trial findings, IoT and OT device manufacturing data, and research subject data. Attacks on the sector could destroy patient prescription records or interfere with critical research.
The pharmaceutical sector has been using AI in automation and security technologies; 40% of businesses claim to employ the technology actively. AI is a very helpful security technique in IoT and OT contexts in the pharmaceutical industry.
The pharmaceutical industry will likely be leaders in the use of automation and artificial intelligence (AI), particularly in the development of generative AI used to analyze data more effectively for anomalies and detect intruders in the network. Other security practices, such as utilizing systems to protect hybrid and multi-cloud environments to build security into software and hardware development, are still essential components of any cybersecurity program.
Large volumes of sensitive data, including patient information and data from clinical trials, are gathered and stored by pharmaceutical corporations. It can be difficult to ensure the security and integrity of this data in the age of cyberattacks and data breaches, but it is essential. The pharmaceutical and healthcare industries have a lot in common. Pharma’s network architecture not only houses patient data but also company private data, including drug patent intellectual property, clinical trial findings, IoT and OT device manufacturing data, and research subject data. Attacks on the sector could destroy patient prescription records or interfere with critical research.
The pharmaceutical sector has been using AI in automation and security technologies; 40% of businesses claim to employ the technology actively. AI is a very helpful security technique in IoT and OT contexts in the pharmaceutical industry.
The pharmaceutical industry will likely be leaders in the use of automation and artificial intelligence (AI), particularly in the development of generative AI used to analyze data more effectively for anomalies and detect intruders in the network. Other security practices, such as utilizing systems to protect hybrid and multi-cloud environments to build security into software and hardware development, are still essential components of any cybersecurity program.
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Aging Population
The need for medications and therapies to address the health problems associated with aging is rising as the world’s population ages. The pharmaceutical sector faces both possibilities and challenges because of this demand as they endeavor to produce new products that meet these needs while controlling healthcare costs.
Governments and health systems must first comprehend the requirements and care preferences of older citizens to respond appropriately to their aging populations. Elderly people’s health needs, preferences, and expectations are changing quickly in this fast-moving global environment. Realizing the goal of a high quality of life for older adults requires consultative processes that guarantee older people have a strong voice in decision-making, involve seniors as actors in their own care, and comprehend care preferences across variables like age, socioeconomic status, and gender. Success will depend on effective coordination with the pharmaceutical and other sectors.
Pharma will need to create cutting-edge therapies that meet the requirements of this market. Big data, social media, and connected gadgets have created new ways to use digital platforms to better understand and cater to the requirements of the aging population. This will assist in identifying which service functionality helps patients achieve the best possible health outcomes in addition to understanding how medications act in particular age cohorts and comorbid situations. To get the best results, it’s not only about who has the best brand; it’s also about who provides the most individualized brand experience.
Technology is crucial for the older population because, although they are becoming more tech-savvy, they also live in environments that make it harder for them to deal with technology—especially small, portable devices. Dealing with technology becomes more difficult in cases of ocular degeneration, reduced motor and mental coordination, and impaired hearing capacities, among other disorders. The information conveyed will be more accurate and beneficial the more we can automate the process. When drug manufacturers genuinely begin to look beyond the next dosage and collaborate with tech firms to develop completely integrated passive systems, everyone will benefit.
The need for medications and therapies to address the health problems associated with aging is rising as the world’s population ages. The pharmaceutical sector faces both possibilities and challenges because of this demand as they endeavor to produce new products that meet these needs while controlling healthcare costs.
Governments and health systems must first comprehend the requirements and care preferences of older citizens to respond appropriately to their aging populations. Elderly people’s health needs, preferences, and expectations are changing quickly in this fast-moving global environment. Realizing the goal of a high quality of life for older adults requires consultative processes that guarantee older people have a strong voice in decision-making, involve seniors as actors in their own care, and comprehend care preferences across variables like age, socioeconomic status, and gender. Success will depend on effective coordination with the pharmaceutical and other sectors.
Pharma will need to create cutting-edge therapies that meet the requirements of this market. Big data, social media, and connected gadgets have created new ways to use digital platforms to better understand and cater to the requirements of the aging population. This will assist in identifying which service functionality helps patients achieve the best possible health outcomes in addition to understanding how medications act in particular age cohorts and comorbid situations. To get the best results, it’s not only about who has the best brand; it’s also about who provides the most individualized brand experience.
Technology is crucial for the older population because, although they are becoming more tech-savvy, they also live in environments that make it harder for them to deal with technology—especially small, portable devices. Dealing with technology becomes more difficult in cases of ocular degeneration, reduced motor and mental coordination, and impaired hearing capacities, among other disorders. The information conveyed will be more accurate and beneficial the more we can automate the process. When drug manufacturers genuinely begin to look beyond the next dosage and collaborate with tech firms to develop completely integrated passive systems, everyone will benefit.
The need for medications and therapies to address the health problems associated with aging is rising as the world’s population ages. The pharmaceutical sector faces both possibilities and challenges because of this demand as they endeavor to produce new products that meet these needs while controlling healthcare costs.
Governments and health systems must first comprehend the requirements and care preferences of older citizens to respond appropriately to their aging populations. Elderly people’s health needs, preferences, and expectations are changing quickly in this fast-moving global environment. Realizing the goal of a high quality of life for older adults requires consultative processes that guarantee older people have a strong voice in decision-making, involve seniors as actors in their own care, and comprehend care preferences across variables like age, socioeconomic status, and gender. Success will depend on effective coordination with the pharmaceutical and other sectors.
Pharma will need to create cutting-edge therapies that meet the requirements of this market. Big data, social media, and connected gadgets have created new ways to use digital platforms to better understand and cater to the requirements of the aging population. This will assist in identifying which service functionality helps patients achieve the best possible health outcomes in addition to understanding how medications act in particular age cohorts and comorbid situations. To get the best results, it’s not only about who has the best brand; it’s also about who provides the most individualized brand experience.
Technology is crucial for the older population because, although they are becoming more tech-savvy, they also live in environments that make it harder for them to deal with technology—especially small, portable devices. Dealing with technology becomes more difficult in cases of ocular degeneration, reduced motor and mental coordination, and impaired hearing capacities, among other disorders. The information conveyed will be more accurate and beneficial the more we can automate the process. When drug manufacturers genuinely begin to look beyond the next dosage and collaborate with tech firms to develop completely integrated passive systems, everyone will benefit.
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Public Perception
Pharmaceutical companies are under increasing scrutiny from the public. The problems with the pharmaceutical industry’s reputation are numerous and include problems with drug safety, perceived regulatory inadequacies, pricing and accessibility, marketing, and promotion strategies. Building and maintaining a positive reputation is critical for companies in this industry.
By being more involved in the health-related issues that are now causing the most concern in society and assisting in the removal of the numerous obstacles that keep so many people from leading healthy lives. Pharma companies could, for instance, mobilize their vast resources to assist if people are unable to reach their desired level of wellness due to a lack of trustworthy, consistent information. This could include serving as a resource for trustworthy, accurate, and reliable information on medical conditions and treatments.
Pharmaceutical companies are under increasing scrutiny from the public. The problems with the pharmaceutical industry’s reputation are numerous and include problems with drug safety, perceived regulatory inadequacies, pricing and accessibility, marketing, and promotion strategies. Building and maintaining a positive reputation is critical for companies in this industry.
By being more involved in the health-related issues that are now causing the most concern in society and assisting in the removal of the numerous obstacles that keep so many people from leading healthy lives. Pharma companies could, for instance, mobilize their vast resources to assist if people are unable to reach their desired level of wellness due to a lack of trustworthy, consistent information. This could include serving as a resource for trustworthy, accurate, and reliable information on medical conditions and treatments.
Pharmaceutical companies are under increasing scrutiny from the public. The problems with the pharmaceutical industry’s reputation are numerous and include problems with drug safety, perceived regulatory inadequacies, pricing and accessibility, marketing, and promotion strategies. Building and maintaining a positive reputation is critical for companies in this industry.
By being more involved in the health-related issues that are now causing the most concern in society and assisting in the removal of the numerous obstacles that keep so many people from leading healthy lives. Pharma companies could, for instance, mobilize their vast resources to assist if people are unable to reach their desired level of wellness due to a lack of trustworthy, consistent information. This could include serving as a resource for trustworthy, accurate, and reliable information on medical conditions and treatments.
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Innovation
Pharma distribution organizations are in greater need of more flexible and effective supply chain management solutions due to rising market demand and more stringent laws. Because of the tighter regulations and growing market demand, ERP software systems, for instance, are ideal for Pharma distribution companies since they offer flexible and efficient supply chain management solutions. For the pharmaceutical supply chain to be successful, automation is essential. Pharmaceutical companies may ensure that industry-specific requirements and laws are satisfied, reduce expenses, and improve customer satisfaction by implementing an integrated ERP software system. Pharma ERP software vendors provide license administration and reporting, monitor lots, offer forecasting and procurement, warehouse management, sales force automation, and much more to distributors of all sizes.
Pharma distribution organizations are in greater need of more flexible and effective supply chain management solutions due to rising market demand and more stringent laws. Because of the tighter regulations and growing market demand, ERP software systems, for instance, are ideal for Pharma distribution companies since they offer flexible and efficient supply chain management solutions. For the pharmaceutical supply chain to be successful, automation is essential. Pharmaceutical companies may ensure that industry-specific requirements and laws are satisfied, reduce expenses, and improve customer satisfaction by implementing an integrated ERP software system. Pharma ERP software vendors provide license administration and reporting, monitor lots, offer forecasting and procurement, warehouse management, sales force automation, and much more to distributors of all sizes.
Pharma distribution organizations are in greater need of more flexible and effective supply chain management solutions due to rising market demand and more stringent laws. Because of the tighter regulations and growing market demand, ERP software systems, for instance, are ideal for Pharma distribution companies since they offer flexible and efficient supply chain management solutions. For the pharmaceutical supply chain to be successful, automation is essential. Pharmaceutical companies may ensure that industry-specific requirements and laws are satisfied, reduce expenses, and improve customer satisfaction by implementing an integrated ERP software system. Pharma ERP software vendors provide license administration and reporting, monitor lots, offer forecasting and procurement, warehouse management, sales force automation, and much more to distributors of all sizes.
What is the DSCSA?
Strengthening and ensuring the security of the nation’s pharmaceutical supply chain is the aim of the FDA Drug Supply Chain Security Act, or DSCSA. Congress enacted the Drug Quality and Security Act (DQSA) in November 2013 as a part of the DQSA, which was created to address the dangers related to pharmaceuticals that are counterfeit, tainted, stolen, or hazardous in some other way. To identify and track specific prescription drugs as they are distributed in the US, the act lays out steps to achieve interoperable, electronic tracing of products at the package level. It also describes procedures for electronically tracking and tracing prescription pharmaceuticals at the package level. Its main purpose was to keep illicit and fake drugs out of the American system and to safeguard American consumers by keeping potentially harmful medications out of the drug supply chain to maintain public health. Data pertaining to prescription medications needs to be updated and communicated securely between pharmacies, hospitals, distributors, and manufacturers.
Strengthening and ensuring the security of the nation’s pharmaceutical supply chain is the aim of the FDA Drug Supply Chain Security Act, or DSCSA. Congress enacted the Drug Quality and Security Act (DQSA) in November 2013 as a part of the DQSA, which was created to address the dangers related to pharmaceuticals that are counterfeit, tainted, stolen, or hazardous in some other way. To identify and track specific prescription drugs as they are distributed in the US, the act lays out steps to achieve interoperable, electronic tracing of products at the package level. It also describes procedures for electronically tracking and tracing prescription pharmaceuticals at the package level. Its main purpose was to keep illicit and fake drugs out of the American system and to safeguard American consumers by keeping potentially harmful medications out of the drug supply chain to maintain public health. Data pertaining to prescription medications needs to be updated and communicated securely between pharmacies, hospitals, distributors, and manufacturers.
Strengthening and ensuring the security of the nation’s pharmaceutical supply chain is the aim of the FDA Drug Supply Chain Security Act, or DSCSA. Congress enacted the Drug Quality and Security Act (DQSA) in November 2013 as a part of the DQSA, which was created to address the dangers related to pharmaceuticals that are counterfeit, tainted, stolen, or hazardous in some other way. To identify and track specific prescription drugs as they are distributed in the US, the act lays out steps to achieve interoperable, electronic tracing of products at the package level. It also describes procedures for electronically tracking and tracing prescription pharmaceuticals at the package level. Its main purpose was to keep illicit and fake drugs out of the American system and to safeguard American consumers by keeping potentially harmful medications out of the drug supply chain to maintain public health. Data pertaining to prescription medications needs to be updated and communicated securely between pharmacies, hospitals, distributors, and manufacturers.
What is the Impact of DSCSA in the Pharmaceutical Industry?
The primary goal of the legislation is to maximize patient safety by guarding against patients receiving dangerous or inaccurate medications while also improving the security of our nation’s drug supply. Additionally, by “marrying” the physical product with its digital twin, this law hopes to facilitate a smoother exchange of data across supply chain participants. To put it another way, each product will exist in two states: a digital version that is represented by the information included in the barcode and the product’s transaction event data, and a physical version that has the product identifier data on the label in a format that is legible by humans. This will improve many other operational efficiencies and aid the pharmaceutical sector with inventory accuracy.
The primary goal of the legislation is to maximize patient safety by guarding against patients receiving dangerous or inaccurate medications while also improving the security of our nation’s drug supply. Additionally, by “marrying” the physical product with its digital twin, this law hopes to facilitate a smoother exchange of data across supply chain participants. To put it another way, each product will exist in two states: a digital version that is represented by the information included in the barcode and the product’s transaction event data, and a physical version that has the product identifier data on the label in a format that is legible by humans. This will improve many other operational efficiencies and aid the pharmaceutical sector with inventory accuracy.
The primary goal of the legislation is to maximize patient safety by guarding against patients receiving dangerous or inaccurate medications while also improving the security of our nation’s drug supply. Additionally, by “marrying” the physical product with its digital twin, this law hopes to facilitate a smoother exchange of data across supply chain participants. To put it another way, each product will exist in two states: a digital version that is represented by the information included in the barcode and the product’s transaction event data, and a physical version that has the product identifier data on the label in a format that is legible by humans. This will improve many other operational efficiencies and aid the pharmaceutical sector with inventory accuracy.
Deadlines and Serialization for DSCSA
Serialization & Traceability Deadlines
Serialization & Traceability Deadlines
Serialization & Traceability Deadlines
Date |
Date |
Stakeholders |
Stakeholders |
Requirement |
Requirement |
Nov 27, 2017 |
Nov 27, 2017 |
Nov 27, 2017 |
Manufacturers |
Manufacturers |
Manufacturers |
Serialize smallest-saleable units with unique product identifier (GTIN + serial number + lot + expiry) fda.gov+9tracelink.com+9clarkstonconsulting.com+9dlapiper.comeawlogistics.com+1mckesson.com+1 |
Serialize smallest-saleable units with unique product identifier (GTIN + serial number + lot + expiry) fda.gov+9tracelink.com+9clarkstonconsulting.com+9dlapiper.comeawlogistics.com+1mckesson.com+1 |
Serialize smallest-saleable units with unique product identifier (GTIN + serial number + lot + expiry) fda.gov+9tracelink.com+9clarkstonconsulting.com+9dlapiper.comeawlogistics.com+1mckesson.com+1 |
Nov 27, 2018 |
Nov 27, 2018 |
Nov 27, 2018 |
Repackagers |
Repackagers |
Repackagers |
Same serialization requirement |
Same serialization requirement |
Same serialization requirement |
Nov 27, 2019 |
Nov 27, 2019 |
Nov 27, 2019 |
Wholesalers/Distributors |
Wholesalers/Distributors |
Wholesalers/Distributors |
Only ship serialized product; verify identifiers |
Only ship serialized product; verify identifiers |
Only ship serialized product; verify identifiers |
Nov 27, 2020 |
Nov 27, 2020 |
Nov 27, 2020 |
Dispensers (pharmacies) |
Dispensers (pharmacies) |
Dispensers (pharmacies) |
Verify product identifiers and handle TI/TH/TS data |
Verify product identifiers and handle TI/TH/TS data |
Verify product identifiers and handle TI/TH/TS data |
Nov 27, 2023 |
Nov 27, 2023 |
Nov 27, 2023 |
All stakeholders |
All stakeholders |
All stakeholders |
Electronic, interoperable, package-level tracing becomes mandatory |
Electronic, interoperable, package-level tracing becomes mandatory |
Electronic, interoperable, package-level tracing becomes mandatory |
Stabilization & Extension Periods
Nov 27, 2023 – Nov 27, 2024: FDA granted a 1‑year stabilization phase; during this time, enhanced electronic tracing requirements were not actively enforced (fda.gov).
Oct 9, 2024: FDA issued phased exemptions for entities making progress but needing extra time:
Manufacturers & Repackagers: Extended to May 27, 2025
Wholesale Distributors: Extended to Aug 27, 2025
Large Dispensers (26+ FTEs): Extended to Nov 27, 2025
Small Dispensers (≤25 FTEs): Extended to Nov 27, 2026
What is Track and Trace for Pharmaceuticals?
With pharmaceutical track and trace, you can quickly find the current and past locations of any item in your supply chain. Without this useful tool, no pharmaceutical company can function, particularly considering the increasing number of regulations requiring the recording, sharing, and tracing of supply chain data.
Anything that can be tracked can be observed at both its planned location, which can be a factory, warehouse, pharmacy, or hospital, and its current position. That “something” could be a pallet of products, individual boxes on that pallet, or individual items within each box.
An object’s history and the individuals who have handled it (such as when and when it arrived at) can be found by tracking it down.
The product identification is an essential part of the product tracing method described in the DSCSA. This necessitates that a product identifier encoded with the product’s lot number, expiration date, and standardized numerical identifier be present on every package and uniform case of product in the pharmaceutical distribution supply chain. Repackagers, Wholesale Distributors, and Dispensers must verify product at the package level, including the standardized numerical identity, under specific situations. This requirement will take effect on November 27, 2018, November 27, 2019, and November 27, 2020, respectively.
With pharmaceutical track and trace, you can quickly find the current and past locations of any item in your supply chain. Without this useful tool, no pharmaceutical company can function, particularly considering the increasing number of regulations requiring the recording, sharing, and tracing of supply chain data.
Anything that can be tracked can be observed at both its planned location, which can be a factory, warehouse, pharmacy, or hospital, and its current position. That “something” could be a pallet of products, individual boxes on that pallet, or individual items within each box.
An object’s history and the individuals who have handled it (such as when and when it arrived at) can be found by tracking it down.
The product identification is an essential part of the product tracing method described in the DSCSA. This necessitates that a product identifier encoded with the product’s lot number, expiration date, and standardized numerical identifier be present on every package and uniform case of product in the pharmaceutical distribution supply chain. Repackagers, Wholesale Distributors, and Dispensers must verify product at the package level, including the standardized numerical identity, under specific situations. This requirement will take effect on November 27, 2018, November 27, 2019, and November 27, 2020, respectively.
With pharmaceutical track and trace, you can quickly find the current and past locations of any item in your supply chain. Without this useful tool, no pharmaceutical company can function, particularly considering the increasing number of regulations requiring the recording, sharing, and tracing of supply chain data.
Anything that can be tracked can be observed at both its planned location, which can be a factory, warehouse, pharmacy, or hospital, and its current position. That “something” could be a pallet of products, individual boxes on that pallet, or individual items within each box.
An object’s history and the individuals who have handled it (such as when and when it arrived at) can be found by tracking it down.
The product identification is an essential part of the product tracing method described in the DSCSA. This necessitates that a product identifier encoded with the product’s lot number, expiration date, and standardized numerical identifier be present on every package and uniform case of product in the pharmaceutical distribution supply chain. Repackagers, Wholesale Distributors, and Dispensers must verify product at the package level, including the standardized numerical identity, under specific situations. This requirement will take effect on November 27, 2018, November 27, 2019, and November 27, 2020, respectively.
How Should a Pharma Company Plan and Prepare?
The pharmaceutical industry deals with a variety of complex problems. But companies that can handle these challenges well and develop innovative products and treatments that meet evolving patient needs have the potential to significantly impact the healthcare sector and improve the lives of millions of people globally.
Here are a few guidelines on how pharmaceutical companies can prepare:
Review your operational processes to ensure DSCSA guidelines are met in the most efficient way possible.
Review your management system (ERP & WMS) to ensure it is ready and able to help you remain compliant with the latest regulations.
Evaluate Traceability solutions and form a partnership with the one that works best for you (and will work seamlessly with your ERP)
Test, Test, Test. Do not wait for FDA enforcement. By then it’s too late. Get all your partners and your data aligned properly now and ensure your processes and systematic functions are ready for scrutiny.
The pharmaceutical industry deals with a variety of complex problems. But companies that can handle these challenges well and develop innovative products and treatments that meet evolving patient needs have the potential to significantly impact the healthcare sector and improve the lives of millions of people globally.
Here are a few guidelines on how pharmaceutical companies can prepare:
Review your operational processes to ensure DSCSA guidelines are met in the most efficient way possible.
Review your management system (ERP & WMS) to ensure it is ready and able to help you remain compliant with the latest regulations.
Evaluate Traceability solutions and form a partnership with the one that works best for you (and will work seamlessly with your ERP)
Test, Test, Test. Do not wait for FDA enforcement. By then it’s too late. Get all your partners and your data aligned properly now and ensure your processes and systematic functions are ready for scrutiny.
The pharmaceutical industry deals with a variety of complex problems. But companies that can handle these challenges well and develop innovative products and treatments that meet evolving patient needs have the potential to significantly impact the healthcare sector and improve the lives of millions of people globally.
Here are a few guidelines on how pharmaceutical companies can prepare:
Review your operational processes to ensure DSCSA guidelines are met in the most efficient way possible.
Review your management system (ERP & WMS) to ensure it is ready and able to help you remain compliant with the latest regulations.
Evaluate Traceability solutions and form a partnership with the one that works best for you (and will work seamlessly with your ERP)
Test, Test, Test. Do not wait for FDA enforcement. By then it’s too late. Get all your partners and your data aligned properly now and ensure your processes and systematic functions are ready for scrutiny.
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