GMP News - Regulatory Affairs

In the course of Brexit, the EMA has already appointed new rapporteurs and co-rapporteurs for approx. 370 centralized authorizations. Read more about EMA's procedure for appointing new rapporteurs.

The final release of drug products without the documented prove of compliance with the specifications is a criterion for exclusion, and not just during an FDA inspection. Find out, what other GMP violations regarding the manufacturing and testing FDA inspectors found during an inspection.

Concerning their activities in the field of ATMP, the EMA Committee for ATMP (CAT) published their work plan for 2018 for the different areas of responsibility from pre-authorisation to used technologies.

The EMA issued the draft of the Guideline ICH Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management and its Annexes for commenting.

The annual report 2016 of the GCP Inspectors Working Group (IWG) has been published. According to the report EU inspectors have found more than 1000 clinical trial deficiencies in 2016. Read more about the Annual report of the Good Clinical Practice Inspectors Working Group 2016.

The EMA recently revised its post-authorization procedural advice for users of the centralized procedure. Read more about new and revised Q&A´s concerning Periodic Safety Update Reports (PSURs).  

The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.