In December 2024, the European Medicines Agency (EMA) introduced an update to its Questions and Answers section for biological medicinal products, marking a pivotal step in regulatory clarity and standardization for the sector.
What’s New?
The latest update highlights a key requirement:
1- Unequivocal Identifiers must now be included for in-house analytical methods in the specification table.
2- Descriptions of these methods, as well as their validation summaries, need to reference unique in-house method identifiers for non-compendial methods.
3- Additional guidance is provided in the update to assist manufacturers in determining the type of identifiers to use.
These changes underscore the EMA’s commitment to improving traceability, accuracy, and consistency in the regulatory framework for biological medicinal products.
Why Does This Matter?
The incorporation of unique identifiers bridges the gap between analytical methods and specifications, ensuring that each method is clearly documented and easily traceable. This improvement is crucial for aligning with best practices in regulatory compliance, quality control, and product development.
Learn more about these updates here: EMA Official Update on Questions and Answers for Biological Products
Need Support?
Navigating regulatory updates can be challenging, but you don’t have to do it alone. Our experts at Asphalion are ready to help you interpret and implement these changes seamlessly.
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