Helping Sponsor Meet EMA Policy 0070 Requirements Blog Post

The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for Human Use, commonly known as EMA’s Policy 0070, requires drug companies to proactively share the...

FAQs on Developing EMA Policy 0070 Submissions Blog Post

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for regulatory approval. After almost five years of being offline (other…