Our Pharmacovigilance experts actively track evolving global regulations—so you don’t have to.
To help simplify pharmacovigilance, we stay ahead of new regulations and guidelines, assess their impact and recommend actions that empower professionals to update their MAH systems, processes and procedures to ensure consistent compliance and drug safety.
What is Decentralized Manufacturing (DM) and why is it important?
Decentralized Manufacturing (DM) in the UK is a regulatory framework that allows medicinal products to be manufactured closer to the point of care—such as hospitals or clinics—instead of centralized factories. This model is especially beneficial for personalized treatments, therapies with short shelf lives and innovative medicines that require rapid deployment.
How does DM impact Periodic Safety Update Reports (PSUR)?
Marketing Authorization Holders (MAHs) must gather data on how the product is used. PSURs should include safety data categorized by manufacturing site to ensure transparency and traceability.
What are the expectations for signal detection in a decentralized model?
- Signal detection must be product-specific as well as to the active substance.
- Processes should be sensitive enough to detect any acute and serious new risks that may emerge at the manufacturing site level.
- Product quality information should be taken into consideration within signal detection.
How should Risk Management Plans (RMPs) adapt to DM?
The pharmacovigilance plan within the RMP should clearly outline how DM affects product use. It should also address any additional safety measures required—such as enhanced monitoring or tracking by batch and manufacturing site.
What’s required for managing and reporting adverse reactions?
MAHs should ensure appropriate measures are taken to identify the product by batch number or other product identifiers if no batch number is available and report them to the licensing authority. If reporting issues arise, follow-up procedures should be put in place to ensure no data is lost or delayed.
What are “Specials” and how are they handled?
“Specials” are unlicensed products used for patients with specific needs. Their safety profiles must still be documented. The person who sells or supplies the product must maintain a record of the following items for at least five years from the date on which the supply of the product is discontinued (last supplied).
Key requirements include:
- Person who received the product and the date on which the sale or supply was made.
- Quantity of the sale or supply.
- The product’s batch number from which the sale or supply was made.
- Details of any reactions to the product sold.
In an evolving regulatory landscape, staying ahead in pharmacovigilance means adapting to new models like decentralized manufacturing while maintaining rigorous safety standards. By aligning practices across signal detection, risk management and adverse event reporting, organizations can ensure patient safety and regulatory compliance—no matter where or how a product is made.
Author
Nitin is an accomplished professional with over 20 years of experience spanning Good Vigilance Practice (GVP), Good Clinical Practice (GCP), bioanalytical science and software validation. He previously held the Senior Manager – GVP QA…