European Commission Consults On New Clinical Trial Inspection And GMP Rules
This article was originally published in SRA
The European Commission is in the early stages of drafting legislation that will describe in detail how inspections of clinical trials are to be conducted in the EU and elsewhere once the provisions of the new clinical trials legislation kick in around mid-2016. It is also drafting new guidance on the manufacture of investigational medicinal products (IMPs) used in clinical trials.
You may also be interested in...
Two new legal acts have been adopted by the European Commission specifying updated good manufacturing practice requirements for investigational medicinal products and finished medicines. The legislation take into account recent updates to the EU rules on the safety of medicines.
The European Commission has issued revised delegated legislation explaining new GMP requirements and inspection arrangements for investigational medicinal products that will come into play when the EU Clinical Trials Regulation kicks in.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.