On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical Trials Regulation. The document supplements the EU Delegated Regulation adopted in 2017 setting out GMP obligations for investigational medicinal products. The Delegated Regulation establishes a pharmaceutical quality system for manufacturing operations.

The guidelines govern manufacture and import into the EU of investigational medicinal products for human use. The purpose of the GMP guidelines is to provide appropriate yet flexible tools to address specific issues related to good manufacturing practice requirements for investigational products. The document includes instructions concerning:

  • Pharmaceutical quality systems, in particular, product specification file which should include all of the essential reference documents to demonstrate compliance of investigational drug’s manufacturing with GMP and clinical trial authorisation requirements;
  • Personnel;
  • Premises and equipment;
  • Generation, control and retention of documentation, including specifications and instructions, ordering, manufacturing formulae and processing instructions, packaging and batch records;
  • Production, including packaging materials, manufacturing operations and modification of comparator products as well as blinding operations, packaging and labelling;
  • Quality control;
  • Release of batches;
  • Outsourced operations;
  • Procedures for complaints;
  • Recalls, returns and destruction of investigational drugs.

The guide also recognises a need for co-operation between manufacturers and sponsors of clinical trials under a technical agreement.

The guidelines will become applicable once the Clinical Trials Regulation enters into force, which is expected in 2019.