EU - Draft regulation on the detailed arrangements for the Good Clinical Practice inspections procedures, including the qualification and training requirements for inspectors

European Commission has issued draft implementing Regulation on the detailed arrangements for Good Clinical Practice inspections procedures, including the qualification and training requirements for inspectors, provides for, inter alia:

·  Requirements as regards the experience, training and qualifications for GCP inspectors;

·  Rules on conflict of interest and impartiality for GCP inspectors;

·  Empowerment of inspectors and applicable confidentiality requirements;

·  Obligation for the Member States to adopt detailed procedural rules, inter alia, for the                     appointment of experts accompanying inspectors, arranging inspections in third countries;

· Principle of mutual recognition of inspections findings and obligation of cooperation.

Proposed date of adoption: Mid January 2017

Proposed date of entry into force: The twentieth day following publication in the Official Journal of the EU. The Regulation will be applicable when Regulation (EU) 536/2014 on clinical trials becomes applicable, what is expected not earlier than beginning of 2018.

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.