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News from ICH |
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ICH has published the key outcomes of the
biannual ICH assembly meeting.
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News from HMA |
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Fast EU Pilot Demonstrates Europe′s
Capacity for Accelerated and Coordinated Clinical Trial
Authorisation.
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News from European Commission |
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The European Commission released the 2026
European Semester Spring Package. The package analyses the key
economic and social challenges across the EU and offers policy
guidance to Member States.
Details
As of 28 May 2026, the following
modules of EUDAMED became mandatory to use: Actor
registration, UDI/Device registration, Notified Bodies &
Certificates, Market Surveillance
Details
The European Commission welcomes the
landmark political agreement on the Critical Medicines Act (CMA)
by the Council and the European Parliament. The political agreement
is now subject to formal approval by the European Parliament and the
Council.
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News from the EDQM |
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The EDQM publishes revised CEP guideline. You
can find the document on the EDQM website under ‘Certification
Policy Documents & Guidelines’ in the ‘Operational documents’
section.
Details
The regulatory environment for
active pharmaceutical ingredients (APIs) is changing rapidly. If you
desire a comprehensive overview on upcoming CMC documentation
standards, including the revised CTD structure under ICH M4Q(R2),
impurity control requirements, ASMF, CEP, as well as practical
guidance on eCTD submissions and global post-approval change
management, this is the best choice for you: APIs in the dossier:
Quality data, e-submission, global regulatory strategy (in
English) – 29-30 October 2026.
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News from BfArM/PEI |
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Substances of human origin: The Paul Ehrlich Institute is to
take on key roles under the SoHO Regulation.
Details
In the seminar "Die
SoHO-Verordnung: Ein Überblick der zu erwartenden Neuerungen
nach aktuellem Stand" (in German) – 8 December 2026 – you will be
given an overview of the regulatory changes expected as a result of
the SoHO Regulation.
Details
A new bimonthly publication: BfArM Digital and Health Data
Insights - The programme focuses specifically on key
developments in the fields of health data, digitalisation and
regulatory innovation.
Details
Anyone using AI systems in
pharmaceutical research today needs to be aware of the applicable
obligations, whether the AI practices and systems used in their own
projects fall within the ′high-risk′ category, and what constitutes
a legally compliant approach to research data and the necessary
safeguards. During the seminar "Datenschutz und KI-VO: Leitfaden
für die Pharmaforschung" (in German) – 26 November 2026 - you
will gain practical insights how to handle your individual
situation.
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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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