EDQM举办制药微生物学研讨会，议题含欧洲药典通则1.6修订版与替代微生物方法

Frank and open discussions at the EDQM’s “Microbiology on the Move” symposium

EDQM Strasbourg, France 22/10/2026

From 13 to 15 October 2026, the EDQM hosted a symposium on pharmaceutical microbiology, bringing together more than 140 participants from 30 countries. The fully booked-out event provided a forum for open exchanges on where pharmaceutical microbiology stands today, where established approaches or requirements need to evolve and where further pharmacopoeial guidance could bring the greatest value.

Pharmaceutical microbiology may be a well-established discipline, but the symposium demonstrated the value of collectively examining the evolution of its standards, in particular by ensuring that it is guided by science, informed by practice and driven by a shared responsibility to patients.

Over three days, various stakeholders – including regulators, manufacturers, suppliers, contract organisations, academia, hospitals and pharmacopoeial experts – spoke openly about the scientific, technical, practical and regulatory challenges they face in their work, each bringing their unique perspectives. The programme centred on four main activities:

• a dedicated training session on the newly revised European Pharmacopoeia general chapter 1.6. Alternative methods for control of microbiological quality;
• a discussion on the role of alternative microbiological methods in addressing testing needs, particularly for products requiring rapid results;
• an exploration of the challenges of microbiological testing of complex matrices, encompassing advanced therapy medicinal products, radiopharmaceuticals, live biotherapeutic products and bacteriophages;
• a review of internationally harmonised pharmacopoeial chapters on microbiology and a discussion on their practical application.

Key outcomes from the symposium will now be reviewed by the EDQM and shared with the European Pharmacopoeia Commission for consideration. Several topics have already been identified as deserving further reflection, potentially leading to future clarifications, the revision of existing texts or the elaboration of new texts. Participants and other interested parties are encouraged to stay tuned for future developments arising from this important exchange of views.

All the presentations given during the symposium will soon be available on our website.

See also:

• New milestone in the development of the certification concept for rapid microbiological methods
• EDQM 2025 Annual Report: Tackling public health challenges (key achievements related to the European Pharmacopoeia)