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Editorial
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Author: Dr Henriette Wolf-Klein, FORUM Institut
für Management GmbH
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On 24 March 2025, the online course "JCA Dossiers & Joint Clinical Assessments" took place.
Anne Willemsen (Co-Chair of the JCA subgroup under the HTA Coordination Group) informed that two JCA procedures have already started (one ATMP and one in the indication of oncology). The procedures are generally planned without clock stops, but CHMP decisions will be awaited.
... Read more
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News from ICH |
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ICH M11 on technical specification (CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CeSHarP)) has reached an Updated Step 2b and can be commented on by 22 April 2025.
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News from European Commission |
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The EU Commission released the open-source HealthData@EU Central Platform.
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News from HMA |
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EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.
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In case you are interested in a general and broad overview of topics that concern ATMPs you are welcome to participate in the seminar "All about ATMP" on 23-24 September 2025.
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More specific information amongst others on ATMPs are addressed in the German-speaking seminar "Human-Gewebe/Gewebezubereitungen zur Anwendung am Menschen" on 13 November 2025.
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News from EMA |
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EMA published a draft reflection paper on linking to electronic product information (ePI) from EU medicine packages. The draft can be commented on by 30 June 2025.
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EMA published a new draft guideline on the quality aspects of mRNA vaccines. The draft guideline can be commented on by 30 September 2025.
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On 4 April EMA informed on an updated timeline regarding human variations electronic Application Forms (eAF).
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eSubmission requirements for APIs are discussed during the German-speaking seminar "APIs in Regulatory Affairs" on 22-23 September 2025.
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News from BfArM and PEI |
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German BfArM informs on the EU Regulation on labelling requirements with regard to "fluorinated greenhouse gases".
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This German speaking course focusses on this topic as well: F-Gase: Die Folgen der neuen EU-Verordnung.
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Bulletin on Drug Safety - Issue 1/2025 has been published by BfArM and PEI.
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Veterinary news |
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EMA published a first report on EU-wide sales and use of antimicrobials in animals.
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The FORUM Institute offers a seminar "Pharmacovigilance in Veterinary Medicines" in June in German.
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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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