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Editorial
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Market Access Biosimilars 2026
The online conference on 11 March 2026 examined current regulatory and economic developments in the biosimilars market – with a focus on Germany.
... Read more
This topic sounds new to you?
Then you might want to learn about the regulatory basics of biosimilars and generic marketing authorisation in our seminar:
Zulassung von Biosimilars, Peptiden und Arzneimitteln mit bekannten Wirkstoffen (in German) – 09 December 2026.
Details
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News from ICH |
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The ICH Expert Working Group developed a Mock Example to illustrate Quality Modules of ICH M4Q(R2) Common Technical Document.
Details
The ICH has published an updated and expanded Q9(R1) Quality Risk Management Briefing Pack.
Details
During the half-day training "Qualitätsrisikomanagement (ICH Q9(R1)): Wenn′s endlich rund läuft" (in German) on 20. July 2026, Dr Stephanie Blum will show how risk assessments and root cause analyses are interlinked, enabling you to ensure compliance across your process landscape in an effective and sustainable manner.
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News from European Commission |
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On 1 April, the Commission will open the second request period for joint scientific consultations (JSCs) for 2026. The submission period is open from 1 to 29 April 2026.
Details
The new publication produced by the Alan Turing Institute and the Council of Europe, titled
"AI, human rights, democracy and the rule of law: A primer
prepared for the Council of Europe," is available for download.
Details
The Council of the European Union has agreed on a position regarding the simplification of regulations on artificial intelligence.
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News from EMA |
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EMA has published the outcome of the public consultation on the
"Data Quality Framework for EU Medicines Regulation: application to Real-World Data" and the revised RW-DQF document.
Details
EMA has published FAQs on the clinical trial sponsor’s workspace in the Clinical Trial Information System (CTIS).
Details
EMA has published the decision of the executive director on the access to financial and administrative incentives for micro, small and medium-sized enterprises.
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The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a draft guidance document outlining how clinical trials should be conducted during public health emergencies (PHEs).
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PRAC adopted on 20 February the “EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports”.
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EMA announced the start of the eCTD v4.0 pilot phase III on forward compatibility for Centrally Authorised Products (CAPs). The planned initial duration of this phase is two to three months, with the possibility of extension if needed.
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If you want a comprehensive update on the EMA-IT systems and their correlation to eCTD 4.0 this seminar might be of interest for you:
Regulatory Operations Update (in German) – 15-16 July 2026.
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The concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients can be commented on by 30 June 2026.
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The GMDP Inspectors Working Group released the 3-year work plan (January 2026 until December 2028). For Chapter 1, Chapter 4, Annex 15, and Annex 22 the working group will provide the European Commission in Q4-2026 with a final text.
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Dr Cornelia Hunke and Dr Timo Kretzschmar will provide you with the latest details on the revision of the EU GMP Guidelines during the half-day course
“EU-GMP-Revision: Kapitel 4, Annex 11, Annex 22” (in German) on 23 June 2026.
Details
The final version of the “Guideline on the Chemistry of Active Substances” was published on the EMA website in March 2026.
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The regulatory landscape for active pharmaceutical ingredients (APIs) is changing rapidly.
To keep pace, it is not enough to simply be familiar with the guidelines.
After attending the seminar "APIs in the dossier: Quality data, e-submission, global regulatory strategy" (in English) on September 29 - 30 2026, you will have a solid understanding of EU/ICH requirements, global regulatory strategies, and emerging trends.
Details
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News from CMDh |
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A new update to Appendix 1 on nitrosamines is available on the CMDh/EMA website.
Details
In the seminar "Verunreinigungen in Arzneimitteln - Fokus Nitrosamine" on November 19 2026 (in German), you will benefit in particular from real-world examples, including: Sample calculations for Acceptable Intake (AI), example scenarios for submissions and resulting questions from the regulatory authority (Step II), use of software to identify degradation pathways (synthesis), pitfalls of the APIC/IPEC questionnaires, etc.
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News for Veterinary medicines |
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The EMA has published the following concept paper: Concept paper for the revision of the Guideline on 4 veterinary good pharmacovigilance practices (VGVP) 5 Module: Signal Management (EMA/522332/2021).
Details
Dr. Matthias Schroedter, Head QPPV Office/ Deputy QPPV/ Veterinary QPPV
Hospital Care Division, Global Pharmacovigilance and Patient Safety und Dr. Cornelia Ibrahim, Consultant Tierarzneimittel, informieren Sie über die
aktuellen PV-Anforderungen bei Tierarzneimitteln
und deren Umsetzung im Unternehmen.
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News from BfArM/PEI |
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The joint announcement by the BfArM and the PEI regarding the entry into force of the revised Variation Classification Guideline on January 15 2026, is available for viewing.
Details
At the "Regulatory and CMC Conference" (in English) on September 29 2026, you will not only receive an update from the regulatory perspective on the “New EU Variation Guideline.”
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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