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

Good Clinical Practice (GCP)

The term ‘good clinical practice’ is defined as follows:

‘Good plinical 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 (Article 2(2)(30) of Regulation (EU) No. 536/2014).

Compliance with Good Clinical Practice in the conduct of clinical trials is regulated in a legally binding manner in the European Union by Regulation (EU) No. 536/2014, which has been in force since 31 January 2022. The Regulation (EU) No. 536/2014 replaces the Clinical Trials Directive 2001/20/EC, and in Germany 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 (Article 2(2)(31) of Regulation (EU) No. 536/2014).

The GCP Inspections Unit of the BfArM is responsible for the following inspections:

• GCP inspections in the context of national and decentralised marketing authorisation procedures and, coordinated by the EMA, in the context of centralised marketing authorisation procedures. These GCP inspections include a retrospective review of the validity of clinical trial data on the efficacy and safety of the medicinal product and of compliance with internationally recognised ethical and scientific standards in the conduct of clinical trials. The 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") (Article 78 Regulation (EU) No. 536/2014; Section 42c and 25(5) AMG) in conjunction with Regulation (EU) No. 726/2004).
• GCP inspections carried out in national authorisation procedures for clinical trials, where the information in the application is verified in preparation of the decision on the authorisation. Such GCP inspections can take place before or, in the case of notifications of amendments requiring authorisation, during an ongoing clinical trial (Article 78 Regulation (EU) No. 536/2014; Article 2 Commission Implementing Regulation No. 2017/556; Section 42c No. 1(a) AMG).
• GCP inspections to decide on measures concerning the authorisation of a clinical trial in accordance with Article 77 of Regulation (EU) No. 536/2014 (Section 42c No. 4 AMG).
• GCP inspections to verify the obligation to report serious breaches pursuant to Article 52 of Regulation (EU) No. 536/2014 (Section 42c No. 3 AMG).
• The BfArM GCP Inspectorate also participates in GCP inspections, which are carried out by the competent Länder authorities as part of their surveillance activities (Section 68(1) AMG) or in GCP Inspections of other Member States in response to requests for assistance (Article 9(4) Commission Implementing Regulation (EU) No. 2017/556).

For further information on Regulation (EU) No. 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 Authority of the Länder 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 focus is on the exchange of experience and the preparation of procedural instructions with a view to the uniform implementation of the German Medicinal Products Act in the supervision of clinical trials.

International cooperation

The Committee for Medicinal Products for Human Use (CHMP) can request GCP inspections as part of centralised marketing authorisation procedures (Regulation (EU) No. 726/2004). These are coordinated by the European Medicines Agency (EMA). The GCP Inspections Unit of the BfArM is regularly involved in these inspections. The inspections are carried out in Germany, within the EU as well as in Non-EU Member States (third countries).

A designated member represents the GCP Inspections Unit of the BfArM in the GCP Inspectors Working Group (IWG). This association 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 to harmonise and coordinate all GCP-relevant activities in the European Community. The GCP IWG is particulary 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 GCP Inspections Unit

Head of GCP Inspections Unit

Dr Torsten Stemmler

Telephone: +49 (0)228 99 307-4365

Representative

Dr Bärbel Witte

Telephone: +49 (0)228 99 307-3736

References and legal bases

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

A selection of the most important legal bases: