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monthly regulatory affairs update |
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{Anrede},
Welcome to the July 2026 edition
of our Regulatory Affairs Newsletter.
With this issue, we share an overview of the most relevant regulatory developments from recent weeks. You will also find a summary of the latest Online Pharma FORUM webcast on the "Human-in-the-Loop"-AI concept in pharmacovigilance. Furthermore, you find a second summary of the latest PharmaFORUM Webcast International. On 1 July 2026, Dr. Anna Thaidigsmann gave a practice-oriented overview of current and upcoming obligations related to the enrichment of PMS product data.
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 the EDQM |
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News from EMA |
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News for Veterinary medicines |
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News from BfArM/PEI |
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Monthly reports |
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Editorial
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On June 3, 2026, Reinhold Schilling — Head of Global Pharmacovigilance, EU-QPPV, and Graduated Plan Officer (Stufenplanbeauftragter) at Wörwag Pharma GmbH & Co. KG in Böblingen — gave a presentation as part of the Online Pharma Forum. His talk examined the use of artificial intelligence in pharmacovigilance, with a focus on the capture, review, and reporting of drug-related risks and adverse events.
... Read more
As part of the PharmaFORUM Webcast International on 1 July 2026, Dr. Anna Thaidigsmann gave a practice-oriented overview of current and upcoming obligations related to the enrichment of PMS product data. The webcast focused on the concrete requirements that marketing authorization holders will face in the coming years and on the role that the Product Management Service (PMS) is expected to play in the future of European regulatory processes.
... Read more
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News from ICH |
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The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met in person on 2–3 June 2026 in Rio de Janeiro, Brazil for its biannual meeting.
Details
CMC in transition: From ICH Q1 to ICH M4Q(R2): What you should be aware of in CMC now!
Are you keen to successfully implement guideline updates? Benefit from the expertise of our experts (authority and industry perspective) and plan strategically: Current Guideline Revisions in CMC (in English) on 25 November 2026.
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New training materials are available to support the implementation of the ICH Q9(R1) Guideline on "Quality Risk Management".
Details
After participating in the seminar Mastering ICH Quality Guidelines: From Development to Lifecycle Management (in English) on 18 November 2026, you will be aware of the relation between the guidelines ICH Q8 to ICH Q12. This will enable you to recognise the opportunities of ICH Q12 and to profitably put the requirements of the guideline into practice.
Details
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News from European Commission |
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Two delegated acts on well-established technologies (WET) under the Medical Devices Regulation have been published today in the Official Journal of the EU.
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News from the EDQM |
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The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its 2025 Annual Report online, presenting key achievements and tangible outcomes for patients, health systems and societies in Europe and worldwide.
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News from EMA |
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Versions 1.28.0.0 of the interactive PDF electronic application form (eAF) for human and veterinary marketing authorisation application are available on the eAF website, together with the associated release notes.
Industry must use the updated eAFs, Version 1.28.0.0, for any new CAP MAA Veterinary or Human application submitted to EMA from 28 July 2026.
The forms can be used for new MAA applications submitted to the NCAs for NP, MPR, DCP and SRP procedures from 1st September 2026. It will be mandatory to use the updated forms for all new MAA submissions to the NCAs from 1st January 2027.
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The Concept Paper on the revision of the guideline “on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease” can be commented on by 30 September 2026.
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The Concept Paper “on the Development of a Reflection Paper on the Use of External Controls for Evidence Generation in Regulatory Decision-Making” has beend adopted by CHMP on 21 May 2026.
Details
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News for Veterinary medicines |
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The EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product Database has been updated with regard to Chapter 7 "Submission of other post-authorisation data".
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News from BfArM/PEI |
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The new Bulletin on pharmacovigilance has been published.
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Substances of human origin: The Paul Ehrlich Institute is to play a key role under the SoHO regulation.
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In case you desire first-hand information on the new regulation and it’s “framework”, we invite you to participate in our seminar “Die SoHO-Verordnung: Ein Überblick der zu erwartenden Neuerungen nach aktuellem Stand” (in German) on 8 December 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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