Avoiding Policy 0070 Pitfalls and Ensuring Compliance
Dec21

Avoiding Policy 0070 Pitfalls and Ensuring Compliance

The European Medicines Agency (EMA) Policy 0070 guidance was initially issued in 2016 and since thenĀ has undergone several iterations. The evolving guidance adds complexities to the Marketing AuthorisationĀ Application submission process, challenging organizations to be agile with their teams and processes as they establish best practices and stay current with policy changes. Although Policy 0070 continues to be expanded for openness...

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Health Canada Revises Rules for eCTD Submissions
Dec08

Health Canada Revises Rules for eCTD Submissions

Health Canada recently announced revised validation rules for regulatory transactions for electronic Common Technical Document (eCTD) submissions.

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