Submission of comments on 'Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA' (EMA/712397/2009)
EuropaBio welcomes the opportunity to comment on the European Medicines Agency draft Reflection Paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA.
We welcome the draft Reflection Paper which addresses important issues related to the increased globalisation of clinical trials. The principles underpinning this paper are supported and well aligned with EuropaBio’s core ethical values. EuropaBio would like to highlight that our member companies are adhering to internationally agreed ethical and GCP standards, no matter where the clinical trials are conducted.
We would like to thank the Agency for inviting EuropaBio to participate in the workshop organised as part of the consultation process on 6-7 September 2010. This was a unique event bringing together national regulatory authorities, ethics committees, patient organisations and sponsors from around the world sharing a common goal, i.e. international cooperation and harmonisation of standards for clinical trials.
At the workshop, it was indicated that the Reflection Paper is aimed at helping with the implementation and practical application of existing ethical principles and GCP standards, and does not set out any new, additional rules. It may, however, contribute to the future development of guidance to fill any gaps identified. Therefore, EuropaBio recommends that the status of this paper is clarified in the context of the EU pharmaceutical legislative framework given its anticipated worldwide readership.