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monthly regulatory affairs update |
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{Anrede},
Welcome to the June 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 summary of the lecture with a focus on "Certificate of Pharmaceutical Product (CPP)" held by Dr Eva Ramtour at the last PharmaFORUM Webcast International on 14th May 2025.
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 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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News from other European organisations |
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Editorial
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Summary PharmaFORUM Webcast International 14 May 2025 –
Certificate of Pharmaceutical Product (CPP)
In the PharmaFORUM Webcast International on May 14, 2025, Dr Eva Ramtour, Regulatory Affairs Manager CPN Chapter at Bayer AG, provided an overview of the requirements for the Certificate of Pharmaceutical Product (CPP). […]
... Read more
Interested in the full presentation? Then we warmly invite you to register for the PharmaFORUM Webcast International. Not sure yet? Feel free to request our demo version and get to know the platform!
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News from ICH |
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The ICH Secretariat announced the publication of the ICH Q5A(R2) "Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin" Guideline training materials.
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The ICH E21 draft Guideline on "Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials" reached Step 2b of the ICH Process in May 2025 and has entered the consultation period.
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News from EMA |
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EMA published a new draft reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in children and adolescents.
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The online conference "Hot Topics Related to Quality in Herbal Medicinal Products" on 27 November 2025 focuses on the current quality guidelines and assessment criteria – authority's perspective and industry's experiences.
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A new version of the EU eCTD M1 Specification, version 3.1.1, is now published on the eSubmission website .
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The EMA developed a concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products.
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EMA published draft ICH M13B Guideline on bioequivalence.
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This is going to be one Hot Topic of the program of the "Regulatory Affairs and CMC Conference", that will be scheduled in early December 2025. We’ll keep you updated.
EMA published a concept paper on the revision of the GMP guideline for ATMPs.
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You desire a comprehensive overview that concern development, quality, CMC, Regulatory Affairs, and Market Access aspects of ATMPs? You are warmly invited to join our online course "All about ATMP" on 23-24 September 2025.
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News from BfArM and PEI |
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BfArM and PEI are playing a key role in the joint European initiative COMBINE, a project aimed at simplifying and accelerating the authorisation procedures for CDx performance studies in connection with clinical trials.
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Veterinary news |
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EMA published a concept paper which addresses the need for a guideline on evaluation of consumer safety of biological active substances of immunological veterinary medicinal products (IVMPs) intended to produce active immunity, e.g. antibodies, against endogenous targets, e.g., cytokines, in food-producing species.
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News from other European organisations |
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In May, the first revision of the guideline "How to read a CEP (PA/PH/CEP (15) 31, 1R)" was published.
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On day three of the German-language online course "CTD - CMC-Handling: Ein Leitfaden zu Inhalt und Format" (24-26 November 2025) you will learn all the essentials about the application upon presentation of a CEP or ASMF.
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APIC published an update of the document "Nitrosamine Risk Management: Guidance for API Manufacturers".
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The aspect "Risk assessment of synthesis – unexpected impurities including nitrosamines" will be addressed during the seminar "APIs in Regulatory Affairs" on 22-23 September 2025.
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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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