EMA Wants More Guidance on Import Requirements

The European Medicines Agency is calling for additional guidance on good manufacturing and good distribution practices for drug importers.  

The guidance is necessary due to the increased complexity of pharma supply chains and increasing numbers of GMP noncompliance statements in the EudraGMDP database regarding third-country manufacturers, according to an EMA concept paper released last week.

Draft guidance on the topic is scheduled for release in January 2016. The document would become Annex 21 of the GMP Guide and would focus on importation activities not explained in the current guidance.

Comments on the concept paper are due to adm-gmdp@ema.europa.euby Aug. 29. Read the paper here: http://www.fdanews.com/05-15-EMA-ConceptPaper.pdf. — Jonathon Shacat