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Editorial
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On 8 June 2026, Dr Alexander Meier, Regulatory Life Sciences Partner
at Morgan, Lewis & Bockius LLP, gave a presentation as part of the
webcast "Update EU Pharma Legislation". The presentation provided a
comprehensive overview of the current status of the revision of the
EU pharmaceutical legislation, known as the General Pharmaceutical
Legislation (GPL), as well as the key substantive changes introduced
by the planned new Regulation and Directive. […]
... Read more
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News from ICH |
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The ICH M8: Electronic Common Technical
Document (eCTD) Implementation Working Group has issued updates to
multiple support materials for eCTD v4.0 which are available
for download.
Details
If you want a comprehensive update on the requirements, timelines
and transition strategies for eCTD 4.0 this seminar might be of
interest for you “Update eCTD 4.0” on 27 October 2026.
Details
The ICH adopted Annex 2 of ICH E6(R3). It sets out additional GCP
considerations for trials that incorporate decentralised elements,
pragmatic designs and/or real-world data.
Details
Anyone using Digital Health Technologies (DHTs) or AI systems in
pharmaceutical research today needs to be aware of the obligations
that apply.
Upon participation in the seminar “Datenschutz und KI-VO:
Leitfaden für die Pharmaforschung“ (in German) on 26 November
2026 you will leave with a thorough analysis of the regulatory
framework, a practical risk assessment tailored to your specific use
cases, and tools for developing a robust compliance strategy.
Details
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News from European Commission |
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The European Commission has published a new
tool to check if a medicinal product is eligible for Joint
Clinical Assessment (JCA).
Details
HTA CG has adopted and published general principles on the use of
Artificial Intelligence in the preparation of the JCA dossier.
Details
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News from the EDQM |
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The EDQM has deployed a new EDQM CEP database feature: full
download of CEP data.
Details
Amongst other topics you will receive an update on ASMF and CEP
procedures during the seminar “APIs in the dossier: Quality data,
e-submission, global regulatory strategy” on 29-30 September
2026.
Details
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News from EMA |
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Version 1.28.1.0 of the interactive PDF electronic application
form (eAF) for human variation application is available on the
eAF website, together with the associated release notes. The form
can be used for new human variation applications submitted to EMA
and NCAs from 3 August 2026. It will be mandatory to use the updated
form for all new human variations submissions from 24 August 2026.
Details
Marketing authorisation holders are invited to participate in a new
end-to-end testing phase for eCTD v4.0 to help validate
submission processes, identify procedural issues and support
readiness across both industry and regulatory authorities. In
preparation for the mandatory use of eCTD v4.0 for new CAP MAAs from
Q1 2028, the strongly recommended use will start from Q1 2027.
Details
EMA has published guidance for industry on implementing Shortage
Prevention Plans (SPP).
Details
You will gain a comprehensive overview of supply shortage
management in the EU - from regulatory obligations to practical
tools in the seminar “EU Supply Shortage Management and the ESMP”
on 3-4 December 2026.
Details
EMA has published Clinical Trial Information System (CTIS)
user guidance on the new safety module on the annual safety report.
Details
EMA has published a concept paper on revision of the Guideline on
similar biological medicinal products, CHMP/437/04 Rev.1.
Public consultation is open until 31 October 2026.
Details
If you want to learn more about the transforming biosimilar
landscape this seminar might be relevant “Update Biosimilars
2026” on 26 November 202.
Details
EMA has published a draft reflection paper on particulars for safety
signals for (traditional) herbal medicinal products. Public
consultation is open until 15 October 2026.
Details
You will gain a comprehensive overview of the regulatory
requirements for herbal medicinal products in our seminar
“Lehrgang: Regulatorische Anforderungen für Phytopharmaka” (in
German) on 12-14 October 2026.
Details
EMA has published procedural guidance to applicants on the
qualification of novel methodologies (QoNM) for medicinal
product development.
Details
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News from CMDh |
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CMDh has updated multiple parts of their procedural guidance for
the submission and processing of variations inlcuding
worksharing and processing of Type IA minor variations.
Details
If you want a concise update on the new variation framework
these seminars might be of interest for you: “Variations in
Europe” on 28-29 September 2026.
Details
„Variations für Praktiker*innen“ (in German) on 27 October
2026.
Details
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News from BfArM/PEI |
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The BfArM Digital and Health Data Insights issue July 2026
has been published.
Details
This seminar – AI in Pharma R&D on 17 November 2026 - offers
a timely opportunity to deepen your understanding of artificial
intelligence (AI) as it reshapes preclinical drug development.
Details
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Global Regulatory News |
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Anvisa updates CBPF procedures and
expands recognition of foreign regulatory authorities
On 15
June 2026, Anvisa published Normative Instruction 451/2026, revising
the procedures for Good Manufacturing Practice Certification, CBPF,
and streamlining the administrative process for companies. At the
same time, the agency expanded the recognition of foreign, including
decentralized, regulatory authorities, enabling broader use of
inspection reports and helping accelerate the review process.
Details
Stay up to date with the latest regulatory developments in Latin
America and join our seminar “Marketing Authorisation in Latin
America“, featuring focused insights into regulatory strategies
in Brazil, Mexico, Peru, Colombia, Chile and Argentina.
Details
Singapore extends e-labelling to Pharmacy-only and GSL medicines
Effective 30 June 2026, Singapore’s Health Sciences Authority, HSA,
extended e-labelling to Pharmacy-only and General Sale List
medicines, allowing companies to replace the physical patient
information leaflet with an electronic version, subject to
applicable eligibility and documentation requirements.
Details
If you need up-to-date regulatory insights on ASEAN, we would be
pleased to welcome you to our webcast series „Regulatory Strategy
for ASEAN“, comprising four sessions of two hours each
and offering a practical overview of approval pathways, dossier
requirements and market entry considerations for pharmaceutical
products across key ASEAN markets.
Details
For a broader international perspective, we also recommend our
seminar “Global Variations and Lifecycle Management“, which
offers strategies for effective lifecycle management across key
regulatory regions.
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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