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Editorial
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As part of the Online Pharma Forum webcast, Lisa-Cathrin Uebel, LL.M., Senior Legal Counsel at STADA Arzneimittel AG, gave a presentation on 12 August 2026 on the topic "Use of AI in Medical Affairs - what is legally permissible?". […]
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News from ICH |
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The ICH and International Society of Pharmacovigilance (ISoP) have signed a Memorandum of Understanding (MoU) to advance global awareness and adoption of harmonised pharmacovigilance requirements.
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ICH released the MedDRA Version 29.1 in English. All 26 language translations will be available on 15 September 2026.
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News from European Commission |
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The European Commission has updated its guidance on the submission of early information for joint clinical assessment (JCA) of medicinal products.
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HaDEA has published an EU4Health call for tenders to support the development of and access to technologies that can prolong the shelf life of active pharmaceutical ingredients (APIs) stored in bulk and produce finished dose forms rapidly. The call is open until 29 September 2026.
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The further training "APIs in the dossier: Quality data, e-submission, global regulatory strategy" (in English) on 28-29 September 2026, includes updates on (Draft) ICH Q1, ICH M4Q(R2)), ICH Q12, Reliance, AI, etc.
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HaDEA has published an EU4Health call for tenders to advance the EU FAB+ PPE pilot, an initiative designed to strengthen the EU′s capacity to ensure rapid availability of personal protective equipment (PPE). The call is open until 15 October 2026.
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News from EMA |
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EMA has published guidance on the revised pre-submission interactions model (PSI).
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The European medicines regulatory network (EMRN) has published a draft on a new data standards framework. Public consultation is open until 18 September 2026.
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Data management will be newly harmonised by the finalisation of the “EU GMP Revision: Chapter 4, Annex 11, Annex 22” which is expected by the end of 2026.
During the eponymous online course on 11 November 2026 (in English) you will learn what the changes to the guideline mean for your practice.
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The EMA published a revised template and supplementary guidance on the “Shortage Prevention Plan (SPP)”.
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During the online course “Lieferantenqualifizierung: GMP-Anforderungen umsetzen“ (in German) on 11 December 2026 you will among other receive an update on the revision of the EU GMP Guidelines (Chapter 4, Annexes 11 and 22) and tips on the safe use of AI and cloud technologies.
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News from CMDh |
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CMDh has updated the guidance published by Member States on the implementation of the Falsified Medicines Directive.
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News for Veterinary medicines |
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The FORUM Institute is offering a seminar on "QPPV & PSMF in der Vet-Pharmakovigilanz" on 14 December 2026 (in German).
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News from BfArM/PEI |
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Invitations were sent out for the public event "In dialogue with BfArM and PEI: CTR and more", to be held on 16 September 2026.
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Global and general European Regulatory News |
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Mexico’s Cofepris has established a simplified procedure for registering medicines previously assessed and approved by Brazil’s Anvisa.
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What do these developments mean for your regulatory strategy? Our interactive online seminar examines real cases across six Latin American markets with local experts from Brazil and Peru.
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The FDA announced the availability of a new draft guidance document entitled ‘Container Closure Systems for Human Drugs and Biological Products’.
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One aspect of the “Hot topics and current challenges” lecture of the seminar “CMC dossier requirements: FDA vs EU” (in English) on 6 October 2026 will be the FDA draft guidance document on container closure systems.
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The International Pharmaceutical Excipients Council Europe (IPEC) has published the updated Version 3 of its ‘Excipient Stability Guide for Pharmaceutical Excipients’ on its website.
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A general overview on current global stability requirements will be given during the online seminar “Global stability: From regulatory framework to practical application” (in English) on 26 November 2026.
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The UK Government has tabled three amendments to the Health Bill concerning information sharing, updates to medicines and medical devices legislation, and the potential development of a future medical device licensing regime.
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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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