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GMP News

ECA ATMP Interest Group - Activities May-August 2026

Find out more about the activities of the ATMP Interest Group between May and August 2026 -  in their report.

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Aseptic Process Simulation/Media Fill also under Scrutiny during European GMP Inspections

The ECA regularly publishes deficiencies identified by the US FDA during its inspections and subsequently published in Warning Letters. The European Union equivalent is the so-called Non-Compliance Reports, which are published via the EudraGMDP database. A recent statement by the French supervisory authority describes deficiencies at a Chinese manufacturer of biosimilars. What did the French authority find?

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EU Pharma Package: Council Adopts New Rules

The package represents a far-reaching reform of the EU's pharmaceutical legislation. It is intended to help ensure fair access to safe, effective and affordable medicines across the EU and introduces several changes of relevance to GMP compliance.

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