Editorial: A mountain of EU GMP changes for 2013

摘要

I was a bit worried about what to address for my first editorial of 2013. I needn't have been concerned because those nice folk in the European Medicines Agency (EMA) European Commission have saved the day with a raft of GMP alterations and proposed changes. The first change I want to address is the radical revision to Chapter 1. I don't propose to review the changes blow by blow, but careful reading shows the clear intent of these modifications. The EU issued the final version of the revision of Chapter 1 of Part I of the EU GMP Guide in September 2012, and this revision was effective from 31 January 2013. The title of Chapter 1 has been changed to "Pharmaceutical Quality System" in order to integrate with the principles described in ICH Q10 (which is published in full as Part III of the EU GMP Guide). The draft changes issued in 2009 included numerous direct quotes from ICH Q10, but these are not included in the final version. However, it should be noted that, by adding new requirements to Chapter 1, they will make it apply to veterinary medicinal products as well as human products in the EU, even though ICH Q10 has not been adopted by VICH. (VICH is a trilateral EU-Japan-USA programme aimed at harmonising technical requirements for veterinary product registration. Its full title is the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products.)