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Editorial
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Author: Dr Rebekka Bitsch, FORUM Institut
für Management GmbH
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The online seminar "Hot Topics in Regulatory Affairs", held in German language on 18 and 19 September 2024, provided participants with a comprehensive overview of current developments in the field of drug approval. Key topics included the EU pharmaceutical legislation, regulatory procedures in the UK, USA, and EU, as well as the latest innovations in eSubmission processes.
... more
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News from European Commission |
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The feedback period for the draft implementing act on EU rules on health technology assessment (EU-HTA) is running from 01 October 2024 to 29 October 2024.
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The challenges that will accompany the implementation of the EU HTA Regulation will be just one of the key topics addressed during the German-speaking online conference Market Access ATMPs/Gentherapeutika on 26 November 2024.
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News from EMA |
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The reflection paper "on the use of Artificial Intelligence (AI) in the medicinal product lifecycle" has been adopted by MWP, CVMP and CHMP.
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Current developments in the "AI world" will be addressed during the seminar "Pharmaceutical industry in transition: The importance of AI for quality & efficiency" on 27 March 2025.
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The guideline "on quality and equivalence of locally applied, locally acting cutaneous products" will come into effect on 2 April 2025.
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The EMA is pleased to inform that the data load of non-Centrally Authorised Product* (non-CAP) information on the PMS Product User Interface (PUI) has been successfully completed. As of now, all human non-CAP and CAP data is available in read-only mode via the PUI on the Product Lifecycle Management (PLM) Portal.
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EMA drafted a reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application.
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On 13 September EMA has published Version 3.3 of the "IRIS guide for applicants".
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News from BfArM and PEI |
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Since September 17, 2024, two new applications "Consent to digital delivery" and "Supergrouping number allocation" have been available for pharmaceutical companies on the PharmNet.Bund portal.
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The bulletin on drug safety was published in issue 3/2024.
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The BfArM has published the preliminary version of the operation and procedure code (OPS) 2025.
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Veterinary news |
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The draft guideline "on risk management requirements for elemental impurities in veterinary medicinal products" can be commented on by 31 January 2025.
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PEI announced a pharmacovigilance report for 2023 in the field of immunological veterinary products (German language).
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The EMA has published an EU Implementation Guide (Vet EU IG) on veterinary medicinal product data in the Union Product Database.
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FORUM Institute is offering a German-speaking seminar on 29 January 2025 - Die Vet-QPPV: Dirigent und Überwacher des Pharmakovigilanz-Systems.
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Kind regards,
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Dr Rebekka Bitsch
Your contact for
Regulatory Affairs (Human)
+49 6221 500-565 |
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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