The EU Commission haspublished a new public consultation on an Implementing Act on Principles and guidelineson good manufacturing practices for medicinal products for human use.

The reason is that once Regulation(EU) No 536/2014 on clinical trials becomes applicable, manufacture and importof Investigational Medicinal Products (IMPs) for the use in clinical trialscarried out under that Regulation cannot follow GMP for IMPs set out inDirective 2003/94/EC. They then have to be manufactured or imported underregulations laid down by the Delegated Act or other specified regulation. It istherefore necessary that Directive 2003/94/EC is revised by a new ImplementingDirective on principles and guidelines of good manufacturing practice formedicinal products for human use (without IMPs).

The EU Commission states that because"good manufacturing practice for medicinal products for human use alreadyexists and is generally well-functioning, there is no need to reinvent thewheel". So the GMP related consultation documents carry over elements setout in Directive 2003/94/EC relating to medicinal products for human use. GMPs for advanced therapy medicinal products will be introduced with a newprovision.

 The sole purpose of thisconsultation is to collect views, relevant evidence and information fromstakeholders to help the European Commission develop its thinking in this area.

Thisdocument does not necessarily reflect the views of the European Commission andshould not be interpreted as a commitment by the Commission to any officialinitiative in this area.

public consultation on an Implementing Act on Principles and guidelineson good manufacturing practices for medicinal products for human use.