The European Union is beginning to ...

The European Union is beginning to provide details about to what extent it expects the pharmaceutical industry to encounter the requirements of its clinical trials directive. It has released a series of consultation documents forward good manufacturing practice and authorizations for manufacturers and importers of investigational medicinal produces At the same time, and separately, it has announced the requirements for its recent common technical document for all applications for marketing authorization--with extensive details of to what extent to manage clinical trials data.

The gaps in the European Union

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