European Medicines Agency user guide for SMEs
||European Medicines Agency
||20 October 2016
The guide aims to support SMEs to better understand the EU legislative framework relating to medicines and the requirements for the development and authorisation of medicines for human or veterinary use. SMEs often have limited experience with regulatory procedures and the guide provides an overview of data requirements to support a marketing authorisation, as well as the regulatory tools available to facilitate medicines’ development. The guide, which follows the chronological stages of developing a medicine, has been completely revised to clarify existing sections.
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