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Your monthly regulatory affairs update {Anrede}, Welcome to the  August 2023 issue of the regulatory affairs newsletter. Today you will receive an overview of regulatory issues of the last few weeks and a summary of the PharmaFORUM Webcast Biologics – lecture on "Non-clinical aspects of RNA-based drug development". Editorial News from the EU Commission News from the ICH News from EMA News from BfArM and PEI Monthly reports Summary: PharmaFORUM Webcast Biologics "Non-clinical aspects of RNA-based drug development", July 19th 2023 Author: Dr Anika Schröter Dr Anika Schröter contributed on 19 July 2023 to the live webcast series with her talk on "RNA-based drugs – classification and impact on non-clinical development". She covered the following content: Variety of RNA-based product class, Regulatory classification, Why does definition and classification matter?, NC programs dependent on classification, "Real life" examples: some common hurdles and pitfalls. ... more News from the EU Commission Sponsors are encouraged to register their clinical trials under CTIS at their earliest convenience. The following questions and answer provide information on the type of clinical trials that sponsors have to transfer to CTIS, on the timeline and on the content of the application for mono- and multinational trials. Details We recommend the German speaking course "Das Clinical Trials Information System (CTIS) für klinische Prüfungen". Details News from the ICH The ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic will come into effect on 30 September 2023. Details The ICH E6(R3) draft Guideline on "Good Clinical Practice"reached Step 2b of the ICH Process in May 2023 and subsequently entered the consultation period. Details The ICH Reflection Paper "International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines" is now available for public consultation until 30 September 2023. Details We recommend the German speaking course "Real World Data in der Klinischen Forschung". Details News from EMA EMA has published the updated PLM Portal – Human Variations eAF Guide to Registration. Details We recommend the German speaking course "Product Lifecycle Management (PLM) Portal in der praktischen Nutzung". Details News from BfArM and PEI BfArM announcemed the list of necessary paediatric medicinal products according to § 35 paragraph 5a SGB V (exemption from German "Festbetrag"). Details Monthly reports PRAC: Details CHMP: Details CMDh: Details Kind regards, 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 Quality, Safety, CMC +49 6221 500-652

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