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monthly regulatory affairs update |
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{Anrede},
Welcome to the May 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.
Additionally, you receive the new "white paper" of our expert Dr Angela Vogt-Eisele on "Environmental Risk Assessment – Legal changes to fortify ERA of pharmaceuticals".
If you have any requests or suggestions, please feel free to contact
us. We look forward to hearing from you!
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Editorial |
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News from ICH |
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News from European Commission |
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News from HMA |
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News from EMA |
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News from BfArM and PEI |
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Veterinary news |
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Monthly reports |
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Editorial
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White paper on "Environmental Risk Assessment – Legal changes to fortify ERA of pharmaceuticals",
author: Dr Angela Vogt-Eisele
The environmental impact of pharmaceuticals is gaining increasing attention, with new regulations on the horizon that could significantly affect the pharmaceutical industry.
The proposed directive on medicinal products for human use aims to enhance environmental sustainability by introducing stricter requirements for Environmental Risk Assessments (ERA) and risk mitigation measures. This whitepaper offers a comprehensive overview of the forthcoming legislative changes, highlights key differences from Directive 2001/83/EC, and provides valuable insights into how pharmaceutical companies can navigate these new challenges efficiently.
... Read more
Gain practical insights into regulatory expectations and current challenges in Environmental Risk Assessment (ERA) in the context of medicinal product approval in our German-speaking seminar on 18 September 2025.
Details
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News from ICH |
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The ICH Q1 draft Guideline on "Stability Testing of Drug Substances and Drug Products" reached Step 2b of the ICH Process and entered the public consultation period.
Details
Within the scope of the German-speaking webcast series "Stabilitätsdaten: CMC-Know-how" on 24 November, 8 and 15 December 2025 (each lecture 3 hours) you will receive an update on the requirements for the stability data for module 3 CTD and its maintenance.
Details
The revision of the e-learning "Stability testing in the ICH region" together with our experts Dr Christina Juli and Dr Beatrix Metzner (Boehringer Ingelheim) is already in full swing. You can look forward to the new product from fall 2025. We will be happy to inform you if you wish. Just get in touch with us.
Details
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News from European Commission |
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The first two joint clinical assessments for medicinal products have started under the Health Technology Assessment Regulation (EU-HTA).
Details
A German-speaking course addresses the upcoming changes in relation to the German AMNOG procedure "AMNOG nach EU-HTA Start".
Details
Amongst others you will receive an overview on the current EU-HTA activities during the German-speaking Seminar "All about ATMP" on 23-24 September 2025.
Details
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News from HMA |
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EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.
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The current GMP & pharmacovigilance challenges for ATMPs in practice will be addressed during the German-speakting seminar "ATMPs/Gentherapeutika: Das 1x1 des Qualitäts- und Risikomanagements" on 12 November 2025.
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News from EMA |
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The draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders has been adopted by the CHMP and will come into effect on 30 September 2025.
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News from BfArM and PEI |
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BfArM informed on substantical and non-substantial modifications in clinical trials and the regulatory consequences (approval necessity ...)
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The PEI in exchange with the German Pharmaceutical Industry Association (BPI) on the regulation of biomedical drugs, joint meeting on April 23, 2025.
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Publication of the Joint Announcement of the BfArM and the PEI on the notification of variations for purely national marketing authorisations.
Details
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Veterinary news |
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EMA has published an overview of its key recommendations of 2024 regarding the authorisation and safety monitoring of veterinary medicines.
Details
Our German-language seminar "Pharmacovigilance in Veterinary Medicines" provides you with compact knowledge on Vet-PV & Vet-PV inspections.
Details
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Kind regards,
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Jean-Marie Bayhurst
Your contact for
Regulatory Affairs (Human)
+49 6221 500-685 |
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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