GCP - Implementing Regulation on Inspection Procedures

The Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 was published on 25 March 2017 in the Official Journal of the European Union. With it, Article 63 of the GCP Regulation (EU) No 536/2014 empowering the Commission to adopt delegated acts will be applied.

The GCP Regulation (EU) No 536/2014 sets the legal framework for the conduct of clinical trials on medicinal products for human use in Europe. Compliance with the legal requirements, the protocol and the principles of good clinical practice, including standards relating to data integrity and ethical conduct of the clinical trial, is to be verified by means of inspections. The responsibility for the performance of inspections lies with the respective Member State where the inspection is carried out.

The Implementing Regulation establishes the detailed arrangements for the inspection procedures with regard to good clinical practice as well as for the requirements on training and qualification, and the powers of the inspectors responsible for the review of good clinical practice. Article 4 "Qualifications, training and experience" of Chapter II "INSPECTORS" requires among other things knowledge in the development and authorisation process of medicinal products and in data integrity (excerpt):

  • Inspectors shall have knowledge of principles and processes that apply to the development of medicinal products and clinical research and have knowledge of applicable Union and national legislation and guidelines on the conduct of clinical trials and the granting of marketing authorisations.
  • They shall be able to assess data integrity as well as aspects related to ethical conduct of clinical trials.
  • Inspectors shall be familiar with the procedures and technical methods for the recording and management of clinical data.
  • Inspectors shall be able to assess the degree of risk as regards the safety of the subjects enrolled in the clinical trial as well as the data integrity.

If necessary, inspections may be performed unannounced. The inspection results shall be recognised by all Member States. If there are any divergences with regard to the verification of compliance with the applicable legislation, the Member States or the EMA within the framework of its powers according to Regulation (EC) No 726/2004 shall inform the Commission. After consultation with those Member States and the European Medicines Agency, the Commission may request a new inspection.

The Implementing Regulation applies from 6 months after the date of publication in the Official Journal of the European Union of the notice regarding the Functionality of the EU portal and the EU database referred to in Article 82 Paragraph 3 of the GCP Regulation (EU) No 536/2014.

The Implementing Regulation (EU) 2017/556 on the detailed arrangements for the inspection procedures with regard to good clinical practice can be found on the EUR-Lex Website.

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