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Feedback Sought On WHO Proposal For Recognizing Well-Performing Regulatory Agencies

Executive Summary

The World Health Organization is seeking comments on a policy document explaining how it plans to evaluate and list regulatory authorities that meet international standards.

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WHO Forges Ahead With New Framework To List Regulatory Authorities

The World Health Organization is to consult on a policy document explaining how it intends to evaluate and list regulatory authorities that meet certain criteria. The new concept of “WHO-listed authority” will replace the current “stringent regulatory authority.”

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

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