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GMP News

EMA Guideline on Quality, non-clinical and clinical Requirements for Investigational Medicinal Products for Advanced Therapies in Clinical Trials

The European Medicines Agency (EMA) has published a comprehensive guideline detailing the quality, non-clinical and clinical requirements for Advanced Therapy Medicinal Products (ATMPs) in clinical trials. This guideline serves as an important guide for developers and researchers to ensure the safety and efficacy of ATMPs during clinical trials.

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Update on the ICH M11 CeSHArP Technical Specification

The ICH M11 Expert Working Group has completed the M11 Technical Specification (TS), incorporating the refinements needed to ensure its alignment with the updated template. A second public consultation on the TS is being conducted to provide the public with an opportunity to review and comment on the updated version.

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European Pharmacopoeia Commission Adopts First General Texts on mRNA Vaccines

The European Pharmacopoeia Commission (EPC) made significant progress in November 2024 by adopting the first three general texts on the manufacture and quality control of mRNA vaccines and their components. These new guidelines provide a standardized framework for developers, manufacturers and regulators in the emerging field of mRNA technology.

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