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New Zealand To Create New Regulator Under Therapeutic Product Reform Bill

Executive Summary

After 10 years in the making, draft legislation for modernizing how medicines and medical devices are regulated in New Zealand has been introduced in parliament for debate.

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EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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Omaveloxolone, Reata Pharmaceuticals’s orphan drug for treating patients with Friedreich’s ataxia, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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Announcing product milestones and liking LinkedIn posts are just some of the topics addressed in a long-awaited guidance that deals with the challenges prescription drug makers face in the UK when using social media.

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