New Timeline Announced for the Implementation of the EU GCP Regulation

In June of this year, the European Medicines Agency, EMA, had announced that the scheduled date for the first application of the EU GCP Regulation 536/2014 would be postponed and that its first implementation is expected only in 2019. Originally, it was scheduled to become effective in October 2018.

The implementation of the EU GCP Regulation depends on the availability and full functionality of the European portal and its associated database, both of which are to be provided by the EMA. During a meeting of the EMA management board on 5 October 2017, the proposal of a new timeline for this project was presented and approved. The EMA announced this timeline in a press release dated 6 October 2017, according to which the EU GCP Regulation will be applied in the second half of 2019 at the earliest. The EMA will communicate a more precise date only after an intensive testing phase with national authorities and industrial representatives.

Related to this is also the applicability of the four EU directives, guidelines and regulations that were or will be published in the course of the new EU GCP Regulation:

• Directive 2017/1572 on principles and guidelines of Good Manufacturing Practice, GMP, for medicinal products for human use,
• Delegated Regulation 2017/1569 for specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections,
• Implementing Regulation (EU) 2017/556 on the detailed arrangements for the good clinical practice inspection procedures,
• The Detailed Commission Guidelines on Good Manufacturing Practices for Investigational Medicinal Products, which have not yet been finally published. These are expected to replace Annex 13 of the EU GMP Guideline.

These as well will only be applied on the first day of the applicability of the EU GCP Regulation.

Learn what fundamental GMP/GCP requirements apply for the development of medicinal products - in the course "GMP meets GCP" from 20-22 November 2018 in Heidelberg, Germany.