The European Commission (EC) is seeking views and relevant evidence on clinical trial inspection procedures, including the qualification and training requirements for inspectors. One of the criteria for making a decision on an application concerning a medicinal product for human use is the assessment of the clinical documentation. According to the introduction and general principles of Annex 1 of Directive 2001/83/EC; “All clinical trials, conducted within the European Union, must comply with the requirements of Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use".
During the assessment of an application, clinical trials, conducted outside the European Union, which relate to medicinal products intended to be used in the European Union, shall be designed, implemented and reported on what good clinical practice and ethical principles are concerned, on the basis of principles, which are equivalent to the provisions of Directive 2001/20/EC. They shall be carried out in accordance with the ethical principles that are reflected, for example, in the Declaration of Helsinki. The Directorate General for Health and Food Safety of the EC has opened the consultation on matters relating to clinical trial inspection pursuant to Article 78(7) of Regulation (EU) No 536/2014, and it includes:
the detailed rules on clinical trials inspection procedures, in particular for the preparation, conduct, reporting, follow up, communication and record keeping and archiving of the inspections;
the co-ordination of the co-operation of the various Member States, and the follow up of the inspections; and
minimum standards of qualification of inspectors, in particular regarding their education and training.
The consultation runs from 28 August until 24 November 2015 and the EC will take all responses into account as it develops the implementing legislation on detailed arrangements for clinical trial inspection procedures. Information gathered from the consultation will be used to inform the Commission’s thinking in this area when it prepares the implementing legislation. The regulation and control of clinical trials throughout the European Community is of paramount importance to the safety of people who agree to participate in clinical trials. Adherence to the principles of good clinical practice is essential to maintaining and developing a safe, and hopefully thriving, environment for conducting clinical trials within the EU.