The GCP Inspections Unit is responsible for verifying compliance with the regulatory requirements for clinical trials in procedures of the BfArM and the European Medicines Agency (EMA), as well as any related issues. The inspections to be performed are regulated in the European context by EU regulations, guidelines and procedural instructions of the EMA GCP Inspectors Working Group (GCP IWG), and in the national context by the German Medicinal Products Act (AMG). GCP inspections are carried out on behalf of the European Community and the results are mutually recognised by the EU member states.

Good Clinical Practice (GCP)

The term is defined in Regulation (EU) 536/2014 as follows:

‘Good clinical practice’ means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust (EU Regulation 536/2014, Article 2.2, sentence 30).

Compliance with Good Clinical Practice is regulated in a legally binding manner in the European Union by EU Regulation 536/2014, which applies from 31 January 2022. The new EU Regulation replaces the EU Clinical Trials Directive (EC) No. 2001/20/EC and the GCP-V. In Germany, the AMG was adapted accordingly with the Fourth Law on the Amendment of Pharmaceutical and other Regulations.

Areas of responsibility

GCP Inspections

‘Inspection’ means the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the clinical trial site, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect (EU Regulation 536/2014, Article 2.2, sentence 31).

The GCP Inspections Unit is responsible for the following inspections:

• GCP inspections conducted within the framework of national and decentralised marketing authorisation procedures and within the framework of centralised marketing authorisation procedures coordinated by the EMA. During these inspections, a retrospective review of the validity of data from clinical trials on the efficacy and safety of the medicinal product and compliance with internationally recognised ethical and scientific standards in the conduct of these clinical trials is performed. These GCP inspections can take place prior to marketing authorisation (so-called "pre-approval inspection"), as well as on an ad hoc basis after marketing authorisation has been granted (so-called "post-approval inspection") ((Art. 78, EU-Verordnung 536/2014; Section 25 (5) AMG in conjunction with Section 15 GCP-V, or EU Regulation 726/2004).
• GCP inspections carried out in national authorisation procedures for clinical trials, where the information in the application is verified in preparation for the decision on the authorisation. Such GCP inspections can be carried out before or, in the case of notifications of amendments requiring authorisation, during an ongoing clinical trial (Art. 78, EU-Verordnung 536/2014; Section 9 (5) of the AMG in conjunction with Section 15 GCP-V).
• Furthermore, in the case of requests for assistance, inspectors of the GCP Inspections Unit of the BfArM participates in GCP inspections carried out by the competent state authorities as part of their surveillance activities (Section 68 (1) AMG and Section 14 (2) GCP-V).

With the EU Regulation 536/2014, the inspection reports will be made publicly available on the EU portal CTIS (EU Regulation 536/2014, Art. 78 (6)). This concerns inspections of clinical trials that have been/will be authorised under the new regulation. For further information on the new EU Regulation 536/2014, please visit the following link: CTIS.

Participation in national committees

The GCP Inspections Unit is represented by a designated member in the Expert Group for Clinical Trials (EFG 05) at the Central Office of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG). The EFG 05 deals with all GCP-relevant issues in connection with clinical trials. The main focus lies on the exchange of experience and the preparation of procedural instructions with regard to the uniform enforcement of the German Medicinal Products Act in the surveillance of clinical trials.

International cooperation

The Committee for Medicinal Products for Human Use (CHMP) can request GCP inspections as part of centralized marketing authorisation procedures (EU Regulation 726/2004). These are coordinated by the European Medicines Agency EMA. The GCP Inspections Unit of BfArM is regularly involved in these inspections. The inspections are carried out in Germany, within the EU as well as in so-called third countries.

A designated member represents the GCP Inspections Unit of the BfArM in the EMA GCP IWG. This working group of GCP inspectors from all EU member states, states of the European Economic Area and some states with observation status (so-called observers, e.g Switzerland), aims at harmonizing and coordinating all GCP-relevant activities in the European Community. In particular, the GCP IWG is involved in the preparation of European Guidelines and Procedural Instructions for the implementation of the European Directives on Clinical Trials and Investigational Medicinal Products.

Contact persons

Head of GCP Inspections Unit

Dr. Torsten Stemmler, Tel.: +49-(0)228-99-307-4365

Representative

Dr. Bärbel Witte, Tel.: +49-(0)228-99-307-3736

References

GCP inspections are based on the respective legal bases at the time the clinical trial is conducted.

The EU Regulation 536/2014 is in force since 31.01.2022. For clinical trials that have been or will be submitted under Directive 2001/20/EC, the transitional provisions of EU Regulation No 536/2014 apply.

A selection of the most important current legal bases: