Annex 13: Detailed Commission Guideline on GMP for IMPs published

The Commission Delegated Regulation (EU) 2017/1569 was issued on 23 May 2017. It supplements the EU Clinical Trials Regulation (CTR) 536/2014 by specifying principles and guidelines for good manufacturing practice (GMP) for investigational medicinal products (IMPs) for human use and arrangements for inspections. Now the Detailed Commission guidelines on GMP for IMPs for human use have been published as final on EudraLex Volume 4 in Annex 13. Additionally, the guideline is provided in EudraLex Volume 10 (Clinical trials guidelines) together with the Template for IMP batch release in Chapter III - Quality of the investigational medicinal product.  

The existing Annex 13 Manufacture of Investigational Medicinal Products is still applicable. The Detailed Commission guidelines on GMP for IMPs for human use and the Template for IMP batch release will only have to be applied from the date the CTR is applicable.

The implementation of the EU GCP Regulation (CTR) 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. As reported before it is expected that the CTR will be applied in the second half of 2019 at the earliest.

Amongst others, the Detailed Commission guidelines on GMP for IMPs lay down the responsibilities of the Qualified Person (QP) regarding the release of IMPs. They are described in detail in chapter 8 Release of Batches. According to chapter 8 the QP has to certify in line with the CTR and with Annex 16 of the EU GMP Guideline:

  • Release of IMPs should not occur until after the QP has certified in line with Article 62(1) of the CTR that the requirements of Article 63(1) and (3) of the CTR and those set out in Article 12 of the Commission Delegated Regulation (EU) No 2017/1569 are met.
  • Assessment by the QP of each batch for certification prior to release should take account of the principles detailed in EudraLex, Volume 4, Annex 16.

According to the Template for IMP batch release IMPs "may not be used in a clinical trial in a member state of the European Union until the completion of the two-step procedure referred to in the "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".

The first step is the certification of each batch by the QP of the manufacturer or importer in line with Article 62(1) of the CTR. This is supposed to ensure that the provisions of 63(1) and 63(3) of the CTR and those set out in Article 12 of the Commission Delegated Regulation (EU) 2017/1569 have been complied with and documented. The second step is the regulatory release by the sponsor for use in a clinical trial.

The IMP Working Group of the European QP Association already provided a comprehensive comparison of Annex 13 with the draft of the Detailed Commission guidelines on GMP for IMPs. It is available in the EQPA IMP Group Member´s Area. For more details please see the EQPA IMP Working Group's comments to the Commission Delegated Regulation on GMP for IMPs.

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