Leaders from the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is home to the European Pharmacopoeia (PhEur), participated in two public outreach events in May 2026. The first was on pharmacopoeial harmonisation in collaboration with United States Pharmacopoeia (USP), and the second on fast track and reliance opportunities for the Certification of Suitability (CEP) procedure.
In the USP-EDQM Stakeholder Forum held at the USP premises in Rockville, Maryland, US, on 6 May, key topics discussed were risk-based approaches to compendial standards, strategic priorities for each organisation, how pharmacopoeias are adapting workplans to shifting quality paradigms within industry, and prospective harmonisation for globally aligned standards.
Throughout the introductory remarks by the heads of USP and EDQM and the ensuing discussions, the need for stronger dialogue, clear alignment, and more effective coordination between the public and private sectors, as well as between EDQM and USP, was emphasised. The forum underscored the necessity of international cooperation to address complex supply chains and evolving scientific challenges, with the aim of improving patient access to quality medicines.
Shortly after, on 11 May, EDQM held a webinar on the CEP procedure, specifically on two aspects strongly aligned with the aims of the stakeholder forum:
- Fast-track assessment to support efforts in addressing shortages of active substances
- Reliance procedures to enhance harmonised and consistent regulatory processes, and to increase efficiency and optimise resources
EDQM has established a Fast-Track and Reliance Team to formalise these procedures and raise awareness of them. The team’s goal is ‘to facilitate and accelerate access to quality-assured and safe APIs while ensuring regulatory alignment’. The webinar speakers explained the background, processes and requirements for each pathway, then answered questions from participants.
The webinar was recorded and is available on the EDQM e-learning resources page. A recording is also available on the EDQM events page of a conference held in Budapest, Hungary, in September 2025, titled ‘Certified for success - using the CEP procedure to elevate quality and drive trust’. The conference brought together stakeholders from EDQM, the European Medicines Agency (EMA), national medicines authorities from across Europe, the Egyptian Drug Authority, the World Health Organisation, Pharmaceutical Inspection Co-operation Scheme (PIC/S), API manufacturers, and industry associations, to discuss recent CEP developments and opportunities for the future, good manufacturing practice (GMP) expectations for APIs, and how the potential of CEPs can be maximised globally.
