abpi News

This promises to be a busy legislative year for the manufacturing side of the pharmaceutical industry with a number of initiatives progressing - particularly in Europe.
In the area of medicines legislation there are two very significant on-going manufacturing topics. The first is the European Commission's proposal to amend the medicines legislation in the EU, including a review of the provisions relating to manufacture. The most radical proposal is the inclusion for the first time of the need for Good Manufacturing Practices (GMP) to apply to the production of active pharmaceutical ingredients (APIs). While it does not seem that the Commission is seeking the establishment of a licensing system for such materials, it will expect product licence holders to confirm that their APIs are manufactured in conformance with GMP. There will be the provision for inspection but the detail of how the Commission sees the system working is, at the current time, unclear.
The other topic that will be the subject of much debate during the spring is the manufacture of clinical trials materials. From May 2004 all clinical trial materials must be manufactured in facilities that are licensed by the competent medicines authorities and meet the requirements of GMP. The Annex to the EU Guide relating to investigational products will be revised and a first draft of a revision is currently out for consultation by interested parties until May of this year. There will be very close scrutiny of and, no doubt, significant comment on the document on behalf of industry.
Watch this space for the developments as they occur.