EMA更新生物等效性科学指南信息页，说明ICH M13A、M13B与M9对欧盟框架的影响
EMA Updates Information Page on Bioequivalence Guidelines
2026年10月14日，EMA更新“生物等效性研究—科学指南”信息页，说明新ICH指南如何影响欧盟监管框架，指南本身未变。ICH M13A自2025年1月25日起已替代欧盟即释口服制剂生物等效性研究设计、实施与数据分析相应章节；ICH M13B将于2027年3月17日生效，替代EMA关于额外规格生物豁免的现有要求。
On 14 October 2026, the European Medicines Agency (EMA) updated its information page "Investigation of bioequivalence - Scientific guideline". The update explains how new ICH guidelines affect the European regulatory framework. The guideline itself has not been changed. The guideline sets out requirements for the design, conduct, and evaluation of bioequivalence studies for immediate-release dosage forms with systemic action. The page highlights the following: ICH M13A: Since 25 January 2025, this guideline has replaced the corresponding sections of the European guideline on study design, conduct, and data analysis for bioequivalence studies of immediate-release oral dosage forms. ICH M13B: This guideline takes effect on 17 March 2027. It will replace the existing EMA requirements for biowaivers for additional strengths, provided in vivo bioequivalence has already been demonstrated for at least one strength. ICH M9: Appendix III of the European guideline has already been replaced by the ICH M9 guideline on biopharmaceutics classification system (BCS)-based biowaivers.For further information, please see the EMA website. You can also find articles on the ICH M13A and M13B guidelines in our news archive.
来源：ECA GMP News · gmp-compliance.org