News

Bioassays in the United States Pharmacopoeia - Two Chapters come into Force in Spring

With the publication of chapters <1032> and <1034> on methods and statistics, the United States Pharmacopoeia continues its series of revised and new chapters in the field of bioassays.

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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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FDA: Next Step to Reduce Animal Based Testing Methods

The use of alternatives to animal testing is increasingly becoming a focus for medicines regulatory and supervisory authorities worldwide. On 21 September, the FDA published an update on this matter.

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FDA Publishes Draft Guidance on Potency Testing of Active Immunotherapy Products

In August 2026, the U.S. Food and Drug Administration (FDA) published draft guidance on potency testing for Active Immunotherapy Products (ACTIMPs). It is intended for manufacturers and sponsors who must ensure the consistent efficacy of active immunotherapies throughout the entire product lifecycle. The draft is non-binding and is initially being issued for public comment.

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How GMP Non-Compliance can stop a Marketing Authorisation Application

An EU-based sponsor has withdrawn its marketing authorisation application for a monoclonal antibody submitted to the European Medicines Agency (EMA), following unresolved concerns about the contract manufacturing site's GMP compliance that had also affected the FDA approval process.

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What is meant by a Contamination Control Strategy (CCS) as defined in Annex 1 of the EU GMP Guidelines?

What is a 'Contamination Control Strategy', where is it required, who does it affect, and how can a CCS be established within a company? This brief summary provides information on requirements, content, regulatory background and practical approaches.

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Validation of Microbiological Methods - What do I need to bear in Mind?

When using microbiological methods in quality control or quality assurance, the question of method validation usually comes up, along with whether and to what extent this is required. A number of guidelines and technical documents provide guidance.

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ECA ATMP Interest Group Developments January through April 2026

Find out what the ECA ATMP Interest Group was working on and accomplished in the first four months of 2026 - in the latest report.

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Get Involved in IMPLEMENT-SoHO: Helping Europe Prepare for the New SoHO Regulation

EBMT is inviting the SoHO professional community to help shape the roll-out of the EU’s new Substances of Human Origin (SoHO) Regulation through the IMPLEMENT-SoHO project. A short survey and exchange activities will be designed around the needs you report—so your input now can directly influence what support becomes available.

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What are the GMP Requirements for ATMPs?

ATMPs are medicinal products that differ fundamentally from traditional medicinal products. They are based on genetic, cellular or tissue material. This diversity alone creates regulatory complexity, making it essential to handle and classify the product correctly. But what exactly is the legal background and where are the critical processes?

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