Patient safety: Commission adopts acts on Good Manufacturing Practices for medicines

Focus on Marketed Products and Investigational Medicinal Products

The European Commission adopted two legal acts aimed at improving patient safety in the EU through good manufacturing practices (GMP) that ensure the highest quality of medicines for human use.

  • The first act 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 second act is a delegated regulation that sets out GMP for investigational medicinal products, as required by the Clinical Trials Regulation (536/2014/EU), and detailed arrangements for inspections. This legal act ensures the highest quality of medicinal products used in clinical trials and prepares the smooth entry into force of this Regulation.

The principles and guidelines for GMP set out in these acts take into account recent updates to the well-established EU rules on the safety of medicines.

Whether a medicinal product is already on the market, or still undergoing a clinical trial, the newly adopted acts aim to ensure the highest level of quality for medicines for the benefit of the patients as well as consistency between the GMP requirements for both types of medicinal products.

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