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Editorial
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Online Pharma FORUM – Update EU Pharmaceutical Legislation
On 9 October 2025, an edition of the Online Pharma FORUM took place on the current status of the EU Pharmaceutical Legislation ("Pharma Package"), featuring Markus Ambrosius, Partner at Sträter Rechtsanwälte.
... Read more
If you want to get a comprehensive overview of all relevant developments and regulatory changes resulting from the new Pharma Package the seminar "Update EU-Pharmapaket" (German) on 05 March 2026 could be relevant for you.
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"The Pharma-Package: authority and industry perspective" is one of the lectures that is addressed during the conference "Hot Topics Related to Quality in Herbal Medicinal Products" on 27 November 2025.
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News from ICH |
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ICH M14 Guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise Real-World Data for safety assessment of medicines comes into force on 18 March 2026.
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News from EDQM |
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EDQM published an update on "Regulatory Reliance and Fast track assessment in the CEP procedure".
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Get first-hand information on further "hot topics" (e.g. an update on (draft) ICH M4Q (R2)) from EDQM representatives during the Regulatory Affairs and CMC Conference on 11 December 2025.
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News from European Commision |
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On the EU Lab Day the Commission announced the planning of a new EU reference laboratory (EURL) for respiratory viruses for early next year to further improve disease surveillance data.
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New and updated documents regarding EudraLex Volume 10: Clinical trials guidelines were published by the Commission.
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The Commission published a new Implementing Decision on harmonised standards for surgical clothing and drapes, medical face masks and sterilizers for medical purposes under the medical devices Regulations.
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The Commission adopted the rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices.
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Health Security Committee (HSC) discusses Union prevention, preparedness and response plan for health crises.
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News from EMA |
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EMA launched the new Combination Products Operational Group (COMBO) to fosters dialogue and address regulatory challenges for combination products.
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EMA partners with healthcare professionals and consumers for #ItTakesATeam medicine shortages campaign.
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ICMRA Summit 2025: EMA’s Executive Director, Emer Cooke, has handed over the role of chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) to Anthony Lawler from the Australian Therapeutic Goods Administration (TGA).
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EMA has published a draft qualification opinion for molecule-independent device bridging approach (MIDBA). Public consultation is open until 19 December 2025.
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EMA has published a draft guideline on quality aspects of phage therapy medicinal products. Public consultation is open until 30 April 2026.
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EMA has published a draft reflection paper on the use of non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation. Public consultation is open until 31 January 2026.
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The European Medicines Agencies Network Data Strategy "Increasing the value of data for the benefit of public and animal health" has been endorsed by EMA Management Board on 2 October 2025.
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News from CMDh |
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CMDh published a post-Brexit Q&A document to provide procedural and practical guidance and address the implications of the withdrawal agreement and the Trade and Cooperation Agreement between the EU and UK.
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CMDh published the recommendations on submission dates in 2026 for applicants of the MRP/DCP.
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Since 24 September 2025 it is strongly recommended to use the PLM Portal web-based eAF for all MRP/DCP and purely national variations, where possible.
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News from BfArM/PEI |
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BfArM has published an updated draft version of the position paper on the distinction of food for special medical purposes (FSMP) and medicinal products. Public consultation is open until 12 December 2025.
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BfArM published that from 1 December 2025 on the new eCTD validation criteria (v8.2) are mandatory to use.
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The PEI publishes tissue vigilance report for 2023.
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Due to popular demand: a rescheduling date of the German-speaking course "Human-Gewebe/Gewebezubereitungen zur Anwendung am Menschen" on 20 May 2026.
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2025 Annual Meeting: Dialogue Between the Paul-Ehrlich-Institut and the Pharma Deutschland Association.
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Veterinary news |
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The Guideline on "in-use stability testing of veterinary medicinal products" came into force on 30 September 2025.
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Join the German-speaking course "Von Stabilität bis ICH M4Q (R2): Implementierungsstrategien" on 27 November 2025 to get your latest update (focus small and large molecules).
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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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