July 2020: EU Fine-Tunes Guidance For New Clinical Trials System – A Pink Sheet Article

The Pink Sheet article dated July 17th reported on a July 1st session at the DIA Europe 2020 Conference on “Clinical Trial Regulation: State of Play – Are We Ready?”. Judith Creba speaking on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA) addressed industry’s preparedness for the new legislation noting “We are as ready as possible, but there are still some unclear aspects, mostly related to CTIS which is understandable as it is still under development.”  Creba, who is leading the CTR’s implementation within Novartis, said the key thing needed to help get the industry fully ready was to provide companies with access to a ‘test’ CTIS database to help them understand how the system works in practice. Both Creda and Rüdiger Pankow of Parexel, raised concerns that many in industry have previously echoed concerning lack of any inside knowledge of the CTIS under development which makes it challenging to have updated internal standard operating procedures to reflect the new procedures and allow for training prior to implementation of the CTR.

Agnès Mathieu-Mendes, deputy head of the unit dealing with the quality, safety and innovation of medicinal products in the Commission’s Directorate General on Health and Food Safety, also stated that a number of new guidance documents and templates are being prepared to help the industry prepare for the legislation.  Work is ongoing to develop new Q&A documents on CTR “hot topics,” such as classification of substantial and non-substantial amendments to a clinical trial, and allowing post-trial treatment access to participating subjects.

The CTIS audit is slated to begin in December 2020 with a proposed ‘Go-Live’ date of CTIS (as well as CTR implementation) in December 2021.

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