European Medicines Agency shared a post on LinkedIn:
”We welcome the publication of the European Commission’s new variations guidelines, which will streamline the lifecycle management of medicines to adapt to scientific and technical advancements.
The new guidelines will facilitate the quick processing of an increasing number of variation requests for existing medicines, benefiting both marketing authorisation holders and regulators.
This is ultimately good news for patients across Europe.
Read our news announcement here.”
Caroline Pothet, Head of Advanced Therapies and Haematological Diseases at European Medicines Agency, shared this post, adding:
”Important achievement today with the publication of the new variations guidelines by the European Commission, intended to facilitate the submission and assessment of post-approval changes for existing medicines.”
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