Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework (PDF)

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.

Emer Cooke, executive director of EMA, is encouraged by the competitiveness of the European pharmaceutical market.