Ministry of Health of Ukraine Order 1528 for Public Release of Trial Results

By Nirpal Virdee, Global Head of Transparency & Disclosure  Over the past several years, Ukraine has taken significant steps with its healthcare services in hopes of matching the high quality, modern healthcare provided in leading western countries. The Ministry of Health (MoH) of Ukraine continues to invest heavily in this ambitious goal. New legislation in parliament in 2017 allowed for a ...

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FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts

By Kristin McDougall, Workstream Lead, Transparency & Disclosure Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s ...

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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 ...

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Implications of FDA’s Decision to Issue Fines for Failing to Submit Clinical Trial Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance last week proposing levying heavy fines on pharmaceutical companies and contract research organizations (CROs) that do not post clinical trial results online. FDA said in the draft guidance, titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” that failure to register trials or submit results to ClinicalTri ...

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