GMP News - APIs and Excipients

The US FDA has published the new fees for 2014. Please read more about the Drug Master File Fee and the API Facility Fee in our GMP News.

The EDQM maintains a database that contains the relevant information about the Certificates of Suitability (CEP). Read more about the changes in the CEP database.

A new EMA Guideline clarifies the most important questions about the definition of starting materials and intermediates of biological medicinal products as well as the quality documentation of the marketing authorisation dossier. More details here.

The FDA has published a new Draft Guidance on "Limiting an inspection" for comment. The document provides a detailed presentation of behaviours during a FDA inspection which may be seen as obstruction by the FDA inspectors. More details here.

The regulation regarding the imports of APIs into the EU which must be accompanied by a Written Confirmation has been effective since 2 July 2013 and keeps on raising new specific questions. The DHMA (Danish Health and Medicines Authority) has recently published a Questions & Answers document. Read more here.

API consignments without Written Confirmation which are trapped on the EU external borders and held under quarantine - how to handle this situation? A guideline of the HMA provides the answer. Read more here.

The EMA Guideline on the European Drug Master File (ASMF) Procedure was updated again. Learn more about the new requirements API manufacturers and applicants will be facing.