On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (“GMP”) requirements for investigational and authorised medicinal products in the EU. The purpose of these legal acts is to ensure the highest level of quality for medicinal products for the benefit of patients. The acts take into account recent updates to the well-established EU rules on safety of medicinal products.
The first adopted act is an implementing Directive 2017/1572 (“implementing Directive”) which supplements Directive 2001/83/EC as regards the principles and guidelines of GMP for medicinal products for human use. The implementing Directive introduces a number of rules and obligations for EU Member States, such as the obligation to ensure that manufacturers respect the GMP principles and guidelines. Other EU Member State obligations introduced concern the supervision of manufacturers in relation to their compliance with marketing authorisation, maintenance of a pharmaceutical quality system and production operations. The implementing Directive also provides rules for manufacturers in relation to personnel, premises and equipment, documentation quality control and self-inspection requirements.
The second adopted act is a delegated Regulation 2017/1569 (“delegated Regulation”) setting out GMP obligations for investigation medicinal products. The delegated Regulation provides that manufacturing operations should be subject to a highly effective pharmaceutical quality system. The delegated Regulation is separated in three Chapters. Chapter I governs the principles and guidelines of good manufacturing practice for investigational medicinal products for human use and the arrangements for inspections of manufacturers.
Chapter II provides the rules related to manufacturing operations which should comply with clinical trial authorisation legislation. In addition, manufacturers should establish and maintain an effective pharmaceutical quality system and have a sufficient number of competent qualified personnel. Manufacturers should also ensure that premises and manufacturing are located, designed and maintained to suit the intended operations. Moreover, Chapter II includes provisions concerning production operations, quality control systems, qualified person responsibilities, outsourced operations, complaints and product recall, self-inspection and advanced therapy investigational medicinal products. Chapter III provides the rules concerning the inspections on investigational medicinal products.
EU Member States must transpose the implementing Directive into their national law by 31 March 2018. The implementing Directive and the delegated Regulation will apply six months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of the Clinical Trials Regulation or 1 April 2018, whichever is the later.