EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update - Major Changes Several major changes are noted in this “Summary of Changes” document, including: Cl ...

Read More

EMA’s Implementation of Policy 0070: Highlights From Year One

The European Medicines Agency (EMA) published its first report on the implementation of Policy 0070 for the publication of clinical data. As of October 2016, the EMA publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralized procedure. The 27-page report, published July 16, 2018, covers one year from the launch o ...

Read More