Submission of comments on the Draft detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’).

30.09.2010

Submission of comments on the Draft detailed guidance on the collection,  verification and presentation of adverse reaction reports arising from clinical trials  on medicinal products for human use (‘CT-3’). 

EuropaBio welcomes the opportunity to input into the European Commission consultation on the proposed revision of the detailed guidance on the collection, verification and presentation of adverse reaction reports  arising from clinical trials on medicinal products for human use (‘CT-3’).  

Overall, we believe the draft detailed guidance is  a solid and useful piece of work, and we particularly welcome the attempt to streamline expedited safety reporting using EudraVigilance. We strongly recommend that member state specific requirements for SUSAR reporting should be made available at EU level. 

Our comments below represent the feedback from member companies. We hope that the following related issues will be addressed by the Commission when finalising the guidance. 

We are surprised to see that periodic reporting of  SUSARs to Ethics Committees by the sponsor has beendeleted, with all SUSARs now required to be expedited. This would seem to be a retrograde step as Ethics Committees have been requesting sponsors to report  foreign SUSARs periodically and we would therefore request clarification on this issue.  

We are also concerned that a new requirement for investigators to assess 'expectedness' (currently performed by the sponsor) has been introduced. This will place additional workload on both investigators and sponsors and require extensive system changes for no apparent gain. 

For international clinical trials, taking place in  the EU as well as outside the EU, the guidance should clarify when to start ex-EU SUSARs reporting to Member State and to EudraVigilance (e.g. on approval of the trial by the first Member State). It would also be helpful if the guideline addresses the need of sending as “backlog” the ex-EU SUSARs of a clinical trial generated prior to first approval in the EU.  

 

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