EC seeks comment on GMP for active substances

The European Commission has published the latest in a series of concept papers designed to invite comment on the implementation of some measures enshrined in last year’s falsified medicines directive.

The latest document - published on January 20 - looks at the delegated act that will be drawn up to determine the principles and guidelines of Good Manufacturing Practices (GMP) for active substances used in pharmaceuticals. The directive calls for these to be adopted in 2013.

Stakeholders are invited to comment on the concept paper by April 20. The overall aim is to develop a single GMP document that encompasses GMPs for both finished medicinal products and active substances, which are currently covered by two separate pieces of legislation.

Additional details will be provided in a forthcoming update. Earlier concept papers have covered equivalence testing for active pharmaceutical ingredient and unique medicine identifiers.