On 28 August 2015, the European Commission launched a public consultation on a new Implementing Act on principles and guidelines on good manufacturing practice (“GMP”) for medicinal products for human use.

Article 46(f) of the Community Code relating to medicinal products for human use imposes on the holder of a marketing authorisation the obligation to comply with principles and guidelines on GMP. The public consultation is intended to collect views, relevant evidence and information from stakeholders regarding the content of a new Implementing Directive governing these principles and guidelines.

Current arrangements

Directive 2003/94/EC enshrines the current principles and guidelines on GMP in the European Union (“EU”). In light, however, of the adoption of Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, new delegated acts are required to reflect the reformed legislative framework for clinical trials in the EU. Directive 2003/94/EC will, therefore, be repealed and replaced by a new Implementing Directive on principles and guidelines of GMP for human use. The legal basis for an Implementing Directive is Article 47 of the Community Code relating to medicinal products for human use.

Expected changes for manufacturers

In the consultation document, the European Commission emphasize that the current principles and guidelines on GMP are generally perceived to be “well-functioning”. As a result, the consultation document does not retreat from the majority of the principles and guidance laid down in Directive 2003/94/EC. The most significant proposed change may be found in the introduction of GMP for advanced therapy medicinal products.

In accordance with Article 5 of Regulation (EC) 1394/2007 on advanced therapy medicinal products, the European Commission must establish guidelines on GMP specific to advanced therapy medicinal products. In Section 2.13 of the consultation document, it is provided that the requirements of the Implementing Directive “shall be adapted to the specific characteristics of advanced therapy medicinal products in accordance with a risk-based approach”.

A separate public consultation on the development of GMP for advanced therapy medicinal products is currently underway. It seeks the views of stakeholders in relation to the requirements that should be applied by manufacturers in light of the terms of a marketing authorisation and advanced therapy medicinal products to be used in clinical trials. It is understood that these specific characteristics will be discussed in detail once the draft proposed Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products are finalised.

The consultation process concerning the new Implementing Directive will remain open until 24 November 2015. Comments may be submitted by interested stakeholders, such as pharmaceutical companies and the competent authorities of EU Member States to IA-GMP-HUMMP@ec.europa.eu.