IMPs: EMA updates timeline for portal and database

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

One of the consequences of the Brexit is that the European Medicines Agency (EMA) will relocate to Amsterdam, the Netherlands, where it has to take up its operations on 30 March 2019 at the latest. Due to EMA´s move to Amsterdam, it has been necessary to adjust the timeline for completing the portal and database for clinical trials as laid down in the Clinical Trials Regulation (CTR).

According to the latest information the required audit for demonstrating full operability of the portal and the database was scheduled to take place by the end of 2018. Due to EMA's relocation to Amsterdam and the subsequent move of the IT development environment as well as the relevant hardware, a temporal adjustment had to be made to the audit plans. The mandatory audit which, if it was successful, is a basic requirement for the application of the CTR, is now to take place once the move of the development data centre to Amsterdam has been completed (see EMA homepage, "Clinical Trials"). It must also be taken into account that the planned move of the staff supporting the execution of the audit on site isn't taking place before March 2019. According to EMA, the previously announced schedule for the initial application of the Clinical Trials Regulation is to be maintained (e.g. in the second half of 2019). However, it is currently expected that it will be mid-2020. That's because the ultimate timeline provides a time interval of 14 months between the audit and the application of the CTR. EMA says: "EMA is monitoring further impact of the relocation and putting in place mitigation measures where possible, in particular in the event of loss of key EMA or developer staff. The clinical trial system continues to be a priority in EMA's Brexit preparedness business continuity plan."

The following documents will enter into force at the same time as the CTR:

• Commission Directive (EU) 2017/1572 on the principles and guidelines of good manufacturing practice for medicinal products for human use,
• Commission Delegated Regulation (EU) 2017/1569 specifying principles 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,
• Detailed Commission Guidelines on GMP for investigational medicinal products (IMPs), which are currently laid down in Annex 13 of the EU GMP Guidelines,
• Template for IMP batch release (currently in Part 3 of the EU GMP Guidelines),
• The EMA guidelines on the two-step release of IMPs, which are referenced in the template for IMP batch release (Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice). Comments on the draft may be submitted until 31 August, 2018.

In addition Part 4 of the EU GMP Guidelines has to be applied regarding GMP for ATIMPs (Advanced Therapy Investigational Medicinal Products) since 22 May, 2018.