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monthly regulatory affairs update |
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{Anrede},
Welcome to the March 2025 edition of our Regulatory Affairs Newsletter.
In this issue, we provide you with a comprehensive overview of the key regulatory developments from the past few weeks. If you have any requests or suggestions, please feel free to contact us. We look forward to hearing from you!
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News from ICH |
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News from European Commission |
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News from EMA |
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Monthly reports |
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News from ICH |
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The ICH M13B draft Guideline "Bioequivalence for Immediate-Release Solid Oral Dosage Forms" reached Step 2b of the ICH Process and can now be commented on.
Details
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News from European Commission |
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The EU Commission has proposed a Regulation to improve the availability of critical medicines in the EU.
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The Regulation (EU) 2025/327 on the European Health Data Space has come into force.
Details
A German speaking training will address this and the consequences for data usage in Germany: Nutzung von Gesundheitsdaten - Industrie & GKV.
Details
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News from EMA |
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As of 29 January 2025, the European Shortages Monitoring Platform (ESMP) is fully operational.
Details
For deeper insights, we recommend our upcoming seminar, "European Shortages Monitoring Platform (ESMP)", on 7 July 2025, featuring leading experts from regulatory authorities and industry.
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EMA announces that the human variations web-based electronic Application Form (eAF)is open for first use for non-Centrally Authorised Products* (non-CAPs) within the PLM Portal.
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Are you encountering challenges in completing PLM-eAF variation application forms? In our upcoming seminar, "eSubmission Update 2025", on 29–30 April, you will gain practical solutions to common data management challenges.
Details
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Kind regards,
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Jean-Marie Bayhurst
Your contact for
Regulatory Affairs (Human)
+49 6221 500-585 |
Dr C. Michaela Gottwald
Your contact for
Regulatory Affairs (Veterinary)
+49 6221 500-610 |
Dr Birgit Wessels
Your contact for
CMC
+49 6221 500-652 |
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Verena Planitz
Your contact for
Global Regulatory Affairs
+49 6221 500-655
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