It is now officially confirmed: On 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) will become applicable. This means some significant changes for clinical trials in Europe with regard to the processes and procedures for authorizing, conducting and terminating clinical trials.
What GMP / GCP changes are coming in connection with the CTR?
On 31 July 2021, the EU Commission confirmed the full functionality of the CTIS (Clinical Trials Information System) by decision in the Official Journal of the EU. This means that six months remain until the Clinical Trials Regulation (CTR) EU 536/2014 will come into application. This will be followed by a consecutive transition period of three years, during which both the contents of the CTR and the current legislation on clinical trials will apply.
The EU Commission has also published several documents, whose applicability is also linked to the first-time application of the CTR, including:
- The “Detailed guidelines on GMP for IMPs for human use” (these are expected to replace Annex 13 of the EU GMP Guide),
- The Template for IMP batch release,
- The Delegated Regulation (EU) No 1569/2017 “GMP for IMPs for human use and arrangements for inspections“,
- The Directive 1572/2017 “GMP for medicinal products for human use“,
- The Implementing Regulation (EU) 556/2017 “Detailed arrangements for GCP inspections“,
- The Q&As on the CTR (currently still available in draft form).
Draft documents of the EMA in connection with the CTR
Current draft documents from the European Medicines Agency (EMA) related to the CTR include:
- The “Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs for human use in accordance with GCP and GMP.”
- Draft guidelines on quality requirements for investigational medicinal products (IMPs).
- The “Guideline on computerised systems and electronic data in clinical trials” with a comment period of six months. The 47-page paper describes, among other things, the requirements for data integrity, computer validation and audit trails, including audit trail review.
The EU Commission’s Decision (EU) 2021/1240 can be found in the Official Journal of the European Union dated 31 July 2021.