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PharmaFORUM Webcast series "CMC requirements in Asia, Japan and Eastern Europe"
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Author: Dr Birgit Wessels, FORUM
Institut für Management GmbH
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On March 7th 2023 Dr Christina Juli contributed to the live webcast series with her lecture on "CMC requirements in Japan and South Korea". Further webcasts of the series focus on China, India and Russia/EAEU. The series covers the requirements for the product classes small and large molecules.
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News from the EU Commission |
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The Revision of the EU general pharmaceuticals legislation seems again delayed.
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The Regulation (EU) 2023/607 introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions. It also deletes in both MDR and IVDR the "sell-off" deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have had to be withdrawn.
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News from the ICH |
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The ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” has reached Step 4 of the ICH Process on 14 March 2023.
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R2 of the ICH Guideline Q5A “on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin” has been published.
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News from EMA |
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The Guideline on computerised systems and electronic data in clinical trials has been adopted by GCP IWG on 7 March 2023 and thus comes into effect in 6 months' time.
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News from BfArM and PEI |
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The Pharmacovigilance Department of the BfArM provides a new publication area in connection with the submission and approval of training material. This is up-to-date information, especially related to individual procedures, for the target group of pharmaceutical companies. The new section complements the already existing information such as FAQ on submission, checklist etc.
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The Bulletin on Drug Safety – current issue 1/2023 – has been published.
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The PEI in discussion with the German Pharmaceutical industry association (BPI) – the main topics: Centralized approval processes, clinical trial approvals, and the second phase of the pilot of multinational advisory meetings and regulatory support for the development of advanced therapy medicinal products (ATMPs).
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Dr Christopher Mann will give a lecture on "First-in-human (FIH) clinical trial applications and INDs for ATMPs: special considerations" on 17 May 2023 within the scope of the PharmaFORUM Webcast Biologics.
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Veterinary news |
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The Draft Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water has been published. The consultation phase ends on 30 June 2023.
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The EMA has published a new FAQ document on the Union Product Database.
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Kind regards,
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Dr Henriette Wolf-Klein
Your contact for
Regulatory Affairs (Human)
+49 6221 500-680 |
Dr C. Michaela Gottwald
Your contact for
Regulatory Affairs (Veterinary)
+49 6221 500-610 |
Dr Birgit Wessels
Your contact for
Quality, Safety,
CMC
+49 6221 500-652 |
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