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GMP News

Switzerland: Update of the Technical Interpretation on the PQR

The Swissmedic's technical interpretation I-SMI.TI.14e on the PQR has been updated. Among other things, it clarifies the responsibilities of the manufacturer and marketing authorisation holder, intervals and responsibilities for parallel import.

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WHO: Update of Guideline of Reference Standards

The WHO recently published the “Working document QAS/25.972” of the “WHO General guidelines for the establishment, maintenance and distribution of chemical reference substances” on the subject of reference standards on its website for comments. The comment period is scheduled to last until May 7, 2025.

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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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