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Editorial
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Online Pharma FORUM – Regulatory
Operations and eSubmission
The recent online Pharma FORUM (19 November 2025) explored key
topics in Regulatory Operations, including XEVMPD, SPOR, PMS,
PLM-eAF and ePI.
... Read more
If you want a deep dive into the ePI topic the seminar
“elektronische Produktinformation (ePI) für Humanarzneimittel”
(German) on 17 June 2026 could be interesting for you.
Details
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News from ICH |
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The ICH Cell and Gene Therapy Discussion
Group (CGTDG), which was established in May 2023, has just published
its recommendations paper, “Recommendations with Regard to Future
Advanced Therapy Medicinal Products-related Guidelines”.
Details
During the seminar “All about ATMP” on 23-24 March 2026, you
will learn to master the challenges from development to approval to
market access of an Advanced Therapy Medicinal Product (ATMP).
Details
The new ICH E22 guideline on general considerations for patient
preference studies is open for public consultation until 12
April 2026.
Details
The International Council for Harmonisation (ICH) confirmed two new
Members and two new Observers at the 51st ICH Assembly in Singapore.
Details
The concept paper on ICH M18: Framework for Determining the
Utility of Comparative Efficacy Studies in Biosimilar Development
Programs has been published.
Details
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News from EDQM |
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The EDQM has published the document
“Stepwise process to get a CEP/having a change approved” for the
first time.
Details
The draft of the 8th revision of the “Guideline on requirements
for revision/renewal of certificates of suitability to the European
Pharmacopoeia monographs” is open for comment until 16 January
2026.
Details
Among other topics, Dr Helmut Vigenschow will address “Possible
procedures for APIs: ASMF, CEP, and US-DMF” in the
German-speaking seminar “APIs in Regulatory Affairs” on 10-11
February 2026.
Details
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News from HMA |
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On 26 November 2025 a large number of
National Competent Authorities (NCAs) and Ethics Committees
committed to test a coordinated fast-track approach for evaluating
multinational clinical trials.
Details
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News from European Commision |
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The European Commission has today proposed
an ambitious package of measures to improve the health of EU
citizens, while ensuring the long-term resilience and
competitiveness of the health sector.
Details
The Commission′s Health Emergency Preparedness and Response
Authority (DG HERA) is addressing one of the root causes of
antimicrobial resistance by investing in rapid diagnostics and
reducing unnecessary antibiotic use.
Details
A new report published as part of the State of Health in the EU
shows Europe urgently needs innovative and resilient health systems
to improve healthcare and boost competitiveness.
Details
The Commission is inviting input on the evaluation of the
Biocidal Products Regulation (BPR), through a Call for Evidence
and public consultation. The consultation is open until 5 March
2026.
Details
The European Commission welcomes the political agreement to
modernise the EU′s pharmaceutical legislation, reached by the
Council and the European Parliament.
Details
If you want a comprehensive overview of the key changes and upcoming
challenges of the new pharma package these seminars could be
relevant for you:
1) “Update EU-Pharmapaket” (German-speaking), 05 March 2026
2) “Webcast: Update EU Pharma Legislation”, 08-25 June 2026 (5
recorded live-sessions)
The Commission′s Health Emergency Preparedness and Response
Authority (DG HERA) and the World Health Organization (WHO) have
signed a €3.5 million agreement under the EU4Health programme
to strengthen the global response to antimicrobial resistance
(AMR).
Details
The Commission has launched a public consultation on health
hazards and risks associated with the use of brain stimulators
for non-medical purpose. The consultation is open until 2
February 2026.
Details
On 28 November, the annual HTA Work Programme for 2026 was
adopted by the Member State Coordination Group on Health Technology
Assessment (HTACG).
Details
The EUDAMED four first modules will be mandatory to use as
from 28 May 2026.
Details
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News from EMA |
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The concept paper on the revision of Annex 3 of the
guidelines on good manufacturing practice for
radiopharmaceuticals is open for public consultation until 15
February 2026.
Details
The new draft guideline on the quality of radiopharmaceuticals
is open for public consultation until 30 April 2026.
Details
The revised guideline on the clinical investigation of medicinal
products in the treatment of patients with acute respiratory
distress syndrome will come into effect on 01 June 2026.
Details
The new guideline on stability testing for applications for
variations to a marketing authorisation will come into effect on
15 January 2026.
Details
In the German-speaking seminar „Aktuelle Guideline-Revisionen in
der CMC-Praxis“ on 11 June 2026, the topic “Update on the
Changes Introduced by ICH Q1” is just one of many hot topics.
Details
The updated questions and answers on post approval change
management protocols (PACMP) will come into effect on 15 January
2026.
Details
Considerations for the management of post-approval changes will be
one aspect that will be addressed during the seminar “CMC
Management in Regulatory Affairs” on 18-19 May 2026.
Details
A draft user manual for the eXtended EudraVigilance Medicinal
Product Dictionary (XEVMPD) user interface (XEVMPDweb) has
been published.
Details
The new information for the package leaflet regarding dextrans
used as excipients in medicinal products for human use has been
published.
Details
The terms of reference for the Combination Products Operational
Group (COMBO) have been published.
Details
The new guideline on the development and manufacture of synthetic
peptides has been adopted by the CHMP and CVMP and will come
into force 1 June 2026.
Details
EMA has launched a call for user acceptance testers for the read
functionality in the Public Product Management Service (PMS)
Application Programming Interface (API). Interested candidates
can forward their applications until 12 January 2026.
Details
The concept paper on the need for revision of the guideline on
clinical investigation of medicinal products in the treatment of
Parkinson’s disease can be commented on by 31 March 2026.
Details
A kick-off meeting of the HMA-EMA group focused on AI with
industry stakeholders was held on 07 November 2025.
Details
If you are interested in exploring the possibilities of AI in the
field of Regulatory Affairs these seminars might be of interest for
you:
1) “Künstliche Intelligenz in Drug Regulatory Affairs”
(German-speaking) on 16 April 2026
2) “Praxisnahe Regulatory Intelligence mit KI-Unterstützung“
(German-speaking) on 22 July 2026
The draft Guideline on non-inferiority and equivalence
comparisons in clinical trials can be commented on by 31 May
2026. la
Details
Q&A Document and Appendix 1 on Nitrosamine Contamination has been updated
again.
Details
An „Update: Titandioxid; Nitrosamine und andere
Nitrosoverbindungen“ from the perspective of the authority will
be provided as part of the German-speaking seminar „Aktuelle
Guideline-Revisionen in der CMC-Praxis“ on 11 June 2026.
Details
The new version of the Q&A Document “European Medicines Agency
post-authorization procedural advice for users of the centralized
procedure” has been published.
Details
The EMA has announced new mandatory eCTD validation criteria
(version 8.2) effective 1 December 2025.
Details
eSubmission requirements for active substances addressed by Dr Henrietta
Dehmlow, Head of Submission Management Small Molecules, F. Hoffmann
La Roche AG, Basel, Switzerland, is only one aspect of interest
during the German-speaking seminar “APIs in Regulatory Affairs” on
10-11 February 2026.
Details
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News from CMDh |
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All news from the “Recently puplished” page for the Human
Medicines section of the CMDh can be found here.
Details
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News from BfArM/PEI |
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The Paul Ehrlich Institute publishes the tissue
vigilance report for 2023.
Details
On 12 May 2026 the German-speaking seminar „Human-Gewebe/Gewebezubereitungen zur Anwendung am Menschen“ will provide you with an overview of the legal and regulatory requirements.
Details
The conference “BfArM meets Europe: Shaping the EHDS” took
place at the end of November 2025.
Details
„Datenschutz in der klinischen Forschung“ (1) or „Datenschutz in
der Pharmakovigilanz“ (2) – two German-speaking FORUM seminars
where you can learn about or update your knowledge of the legally
compliant handling of personal data.
1) „Datenschutz in der klinischen Forschung“
2) „Datenschutz in
der Pharmakovigilanz“
The Drug Safety Bulletin (in German) was published by the
BfArM in issue 4 – December 2025.
Details
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Veterinary news |
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The European sales and use of antimicrobials for veterinary
medicine: Annual surveillance report for 2024 has been provided
on 9 December 2025.
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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