European Commission Adopts Two Acts on GMPs for Medicines

Regulatory News

Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use.

One of the acts is an implementing directive that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization (see Article 40 of the Community code Directive (2001/83/EC)).

The directive, following a consultation on comments in 2015, includes 18 articles on varying topics, including conformity with GMPs, compliance with marketing authorization, pharmaceutical quality systems, personnel, premises and equipment, production, quality control, outsourcing, complaints, recalls and self-inspections.

The second act, meanwhile, is a delegated regulation that sets GMPs for investigational medicines, as required by the Clinical Trials Regulation (536/2014/EU), as well as arrangements for inspections.

The GMPs for investigational medicines "should be aligned as much as possible" to those for medicinal products for human use, the regulation says.

Also on the topic of inspections, the regulation adds: "To achieve and maintain mutual recognition of inspection findings in the Union and facilitate the cooperation of the Member States, commonly recognised standards on the conduct of inspections on good manufacturing practice for investigational medicinal products in the form of procedures should be developed. The Commission guidelines and these procedures should be maintained and regularly updated, according to technical and scientific developments."

The delegated regulation, which also touches on the responsibilities of the qualified person and the retention of samples used for quality control, further says that member states can take action in cases of non-compliance with GMPs for investigational medicines.