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monthly regulatory affairs update |
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{Anrede},
Welcome to the August 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 and a summary of the lecture “Update on Approval Procedures – Outlook for EU Pharmaceutical Legislation” held by Gabriele Eibenstein at the last Online Pharma FORUM on 9th July 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 European Commision |
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News from CMDh |
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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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Summary Online Pharma FORUM 9 July 2025
Update on Approval Procedures – Outlook for EU Pharmaceutical Legislation
On July 9, 2025, the Online Pharma FORUM on the topic of “Update on Approval Procedures – Outlook for EU Pharmaceutical Legislation” took place with Gabriele Eibenstein. Ms. Eibenstein addressed current special features in the approval process, such as accelerated assessment and rolling review, which were developed in the wake of the pandemic, and pointed out current challenges. […]
... Read more
The “Update on the revision of the EU pharmaceutical legislation” by Gabriele Eibenstein will only be one Hot Topic during the Regulatory Affairs and CMC Conference on 11th December 2025.
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News from ICH |
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ICH announces that the updated ICH E2B(R3) Q&As, the Implementation Guide, and Appendix I (G) for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) have reached Step 4 of the ICH Process.
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News from European Commision |
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The Commission invites health stakeholders to submit proposals for a new cycle of Thematic Networks under the EU Health Policy Platform. The deadline for submissions is 22 August 2025.
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HaDEA has published the EU4Health call for tenders. This call for tenders is a service contract for administrative and secretarial support contributing to the implementation and operation of the European Health Data Space (EHDS) Regulation. You can apply by 07 October 2025.
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The Commission has adopted the EU4Health Work Programme, which sets out the strategic policy orientations for 2025.
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The European Commission and the Africa Centre for Disease Control and Prevention (CDC) have launched today the Partnership to Accelerate Mpox Testing and Sequencing in Africa (PAMTA) initiative funded under the EU4Health 2024 programme.
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News from CMDh |
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The European medicines regulatory network has published a response to nitrosamine impurities in human medicines.
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You will receive an update on the current regulatory requirements regarding the handling of nitrosamine impurities during the German-language online seminar Verunreinigungen in Arzneimitteln - Fokus Nitrosamine on 14th November 2025.
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News from EMA |
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EMA published news on ICH E6 Good clinical practice.
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The FORUM Institute’s online conference for regulatory affairs managers explores global regulatory strategies, digital transformation and evidence generation, offering the latest industry developments, expert discussions and practical insights.
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EMA just published a Horizon Scanning Short Report: Review of AI/ML applications in medicines lifecycle.
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The supportive use of AI applications is – amongst others – addressed during the German-language online seminar GMP trifft KI: Effizienzsteigerung mit ChatGPT & Co. on 9th December 2025.
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The revised guideline „on the pharmaceutical quality of inhalation and nasal medicinal products“ comes into force on 1 February 2026.
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The revised guideline on the requirements for demonstrating Therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) comes into force on 1 February 2026.
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On 5 August 2025, updated PLM Portal eAF Release Notes were published, reflecting bug fixes and changes from version 1.2.0.10 released on 4 August 2025. On 8 August 2025, the EU eCTD v4.0 Controlled Vocabularies v2 was released in Excel format, including marked updates and the new Implementation Guide OID (1.3), with the XML version to follow soon.
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For a concise overview of all key eSubmission updates, complemented by practical examples and data management troubleshooting, we invite you to join our upcoming German-language online seminar “Regulatory Submission Update.”
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News from BfArM and PEI |
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Drug Safety Bulletin – current issue 2/2025 now available
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The BfArM and the Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Medicines, offer support within the scope of their responsibilities through various consultation procedures.
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From 1 July 2025, the new regulations for a radiation protection authorisation or notification for clinical trials will apply.
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The European Commission (EU Commission) has published the draft revision of the "Variations Guidelines" on its website in order to give all marketing authorisation holders and authorities sufficient time to familiarise themselves with the new content. The final version is expected to be published in the EU Official Journal at the end of August and to enter into force on 15 January 2026.
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Amongst other you will receive an update on the revision during the German-language online seminar CTD - CMC-Handling: Ein Leitfaden zu Inhalt und Format on 24-26 November 2025.
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The new “Digital Mailbox” application has been online on the PharmNet.Bund portal since August 5, 2025. It can be used to deliver notices and other documents digitally in a legally compliant manner.
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Veterinary news |
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The Committee adopted a revised guideline on demonstration of efficacy for veterinary medicinal products containing anticoccidial substances (EMA/CVMP/EWP/755916/2016) together with the overview of comments received during the two public consultations. The revision will come into effect on 1 February 2026.
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The FORUM Institute offers a seminar on the topic of ”PSMF in Veterinary Pharmacovigilance” on October 1, 2025.
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In addition, the FORUM Institute is offering a new German-language seminar on the topic of
Tierarzneimittel: Marketing & Compliance on October 21, 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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