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monthly regulatory affairs update |
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{Anrede},
Welcome to the February 2026 edition of our Regulatory Affairs Newsletter.
In this issue, we share an overview of the most relevant regulatory developments from recent weeks. You will also find new insights into regulatory requirements related to stability testing in the whitepaper “Stability Testing of Drug Products”.
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 EDQM |
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News from EMA |
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News from BfArM/PEI |
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Veterinary news |
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Monthly reports |
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Editorial
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Whitepaper “Stability Testing of Drug Products”
Author: Dr Helmut Vigenschow
Stay ahead of proposed regulatory changes in pharmaceutical stability testing. This “practical guide” helps you navigate the evolving landscape of EU and ICH requirements, with special focus on the upcoming ICH Q1 draft guideline set for adoption in late 2025. […]
... Read more
Spoiler: Our brand-new e-Learning on “Global Stability Testing” including expected regulatory changes due to the new draft guideline ICH Q1 will be finalised by mid-March 2026. Stay aware of our options for flexible self-directed learning. Your are very welcome to try our e-Learnings for free without any obligation.
Details
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News from ICH |
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Three ICH Expert Working Groups have issued an updated document package, a mapping document and training materials, respectively, associated with three technical Guidelines: E2B(R3): Individual Case Safety Report Specification; ICH M4Q(R2): The Common Technical Document and and ICH E6(R3): Good Clinical Practice.
Details
How do you keep track of the numerous changes to CMC-related guidelines, including the new (draft) ICH M4Q(R2)? Taking into account both the perspective of the authorities and the industry, you will receive a “summary” as part of the German-language online seminar “Aktuelle Guideline-Revisionen in der CMC-Praxis” on June 11, 2026 (an English-language seminar is planned for November 25, 2026).
Details
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News from EDQM |
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In January, the new general chapter on quality of data (5.38) was made available with the publication of the latest edition of the European Pharmacopoeia (Ph. Eur., Issue 12.3).
Details
Details on regulatory adaptions that support digital and technological transformation in the pharmaceutical sector will be addressed during the half-day German-language online seminar EU-GMP-Revision: Kapitel 4, Annex 11, Annex 22, June 23, 2026 (an English-language course will be provided November 11, 2026).
Details
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News from EMA |
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The European Shortages Monitoring Platform (ESMP) is expanding with new functionalities, and the development work is progressing. In addition, new and revised support materials are now available on the ESMP webpage, which has been reorganised with some content moved to two dedicated subpages.
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A Concept Paper for the Development of a Reflection Paper on the use of Bayesian methods in clinical development can be commented on by 30 April 2026.
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A Concept paper on the revision of the Guideline on Clinical Evaluation of Diagnostic agents and its appendix 1 on imaging agents can be commented on by 30 April 2026.
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A Reflection Paper on investigation and assessment of cardiovascular safety of anticancer medicinal products can be commented on by 31 July 2026.
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The EMA published the Questions and answers on post approval change management protocols (PACMP) - Revision 1 on 15 January 2026.
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CMC Changes – PLCM, PACMP & beyond: Mastering Pharma Lifecycle Management – What you need to know now! Dr Andreas Bonertz and Dr Helmut Vigenschow will provide you with essential updates on new/revised (EMA) Guidelines/Papers during our half-day English-language online seminar on June 19, 2026.
Details
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News from BfArM/PEI |
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BfArM included new information on variations for purely national marketing authorisations on their variation website.
Details
One lecture on “Post-approval: Regulatory requirements for the submission of quality-related variations” of the three-day agenda of the English-language online seminar CTD – CMC handling: A guide to content and format on June 17-19, 2026 will be addressed through André Florian Bick.
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Veterinary news |
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A Concept paper on the development of a guideline for using owner assessment as efficacy parameter can be commented on by 30 April 2026.
Details
A draft Guideline for the evaluation of efficacy of ectoparasiticides – general requirements can be commented on by 31 May 2026.
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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