WHO Regulation and Prequalification Update
WHO Regulation
and Prequalification
UPDATE
July 2026
Message from the RPQ Director
Climate change is a major threat to global public health and is already affecting health systems worldwide. At the same time, healthcare systems contribute an estimated 5% of global greenhouse gas emissions, including emissions generated across the pharmaceutical lifecycle – from manufacturing and procurement to use and waste disposal. Regulators have an important responsibility – not only to ensure that medicines remain safe, effective and of assured quality – but also to enable innovations that can reduce the environmental footprint of pharmaceutical products throughout their lifecycle.
WHO’s Department of Regulation and Prequalification (RPQ) is leading global efforts to explore how regulatory systems can support the transition to lower-carbon pharmaceutical products without compromising quality, safety, efficacy or equitable access. As part of the WHO Greener Pharmaceuticals’ Regulatory Highway initiative, RPQ convened a global stakeholder forum in May 2026 and the Global Regulators Summit in June 2026, bringing together regulators, health agencies, industry, procurement organizations and global health partners. The consultations highlighted the need for harmonized standards, stronger international collaboration and practical regulatory pathways to accelerate sustainable innovation. Outcomes will inform a forthcoming WHO white paper providing a global framework for regulatory action on pharmaceutical decarbonization.
Photo: WHO
RPQ mission
RPQ’s mission is to support effective and efficient regulatory systems that protect the public and enable timely access to quality medical products. RPQ provides guidance and support to WHO Member States and facilitates collaboration among stakeholders regarding the regulation of medical products across their lifecycle.
Prequalification
The WHO Prequalification Programme aims to ensure that key health products meet global standards of quality, safety and efficacy. This helps optimize the use of health resources and improve health outcomes.
Assessment of Medical Devices
The first six months of 2026 have delivered important advances in expanding access to quality-assured diagnostics and immunization devices. Five in vitro diagnostics achieved WHO prequalification. Following the Ebola outbreak caused by Bundibugyo virus and the Public Health Emergency of International Concern declaration, WHO opened the emergency use listing to accelerate access to critical diagnostics. A global manufacturers’ workshop strengthened regulatory readiness and engagement. In parallel, immunization device delivery accelerated, with 27 devices prequalified (including refrigerators, cold chain accessories, and injection devices), reinforcing safe vaccine delivery systems. Progress on equipment monitoring systems further enhanced performance data use, while annual review and revalidation ensured continued quality and safety of over 400 products.
Photo: WHO/Philippe Boeuf
Assessment of Medical Products
Several milestones were reached in the assessment of medical products during the first six months of 2026. Annual regulatory trainings on small molecules and biotherapeutics drew over 800 participants, while RPQ held its 150th assessment session, reflecting 25 years of expanding access to quality-assured medicines and contributing to prequalification of over 1060 medicines. The programme broadened its scope to cover diabetes and substance use disorders. RPQ also prequalified two new vaccines (measles and nOPV2). To reflect experiences gained through interaction with stakeholders and new regulatory collaborations, RPQ opened a global public consultation on its vaccine prequalification procedure.
Photo: WHO
Special Prequalification Programmes
The 25th FAO/WHO Joint Meeting on Pesticide Specifications (JMPS) was held in Thailand in June 2026. WHO and FAO form the JMPS Secretariat, which develops recommendations on adopting, extending, modifying or withdrawing specifications that set norms and standards for the quality control of pesticide active ingredients. This year, the meeting assessed 33 applications. An open Call for Experts for the WHO Advisory Group on Pesticide Specifications has also been published to support future JMPS meetings.
Photo: WHO/NOOR/Olga Kravets
Inspections
In the first half of 2026, WHO completed over 100 GxP inspections (71 onsite and 30 desk assessments), published 52 WHO Public Inspection Reports and finished more than 25 quality management system reviews supporting in vitro diagnostic change requests. Key performance indicators stayed on track despite resource constraints. WHO also participated in the Inter-Agency Pharmacists Group meeting, a forum for public health organizations to exchange information on inspections, product assessments and regulatory developments affecting access to quality-assured medicines.
Photo: WHO
Regulation and Safety
Regulation and Safety work focuses on building effective and efficient regulatory systems to protect public health and ensure timely access to quality health products. Aligned with the Department’s Regulatory Action Plan, this work supports WHO Member States by strengthening national and regional regulatory frameworks, increasing preparedness for public health emergencies, facilitating reliance regulatory pathways, and enhancing systems for prevention, detection and response to substandard and falsified medical products and adverse events or reactions. By facilitating collaboration among regulatory authorities and with stakeholders, Regulation and Safety Unit aims to enhance regulatory practices, access to quality medical and health products, ultimately promoting universal health coverage and improving global health outcomes.
Pharmacovigilance
At the 79th World Health Assembly, Member States adopted resolution WHA79.11 to strengthen pharmacovigilance through more integrated, digital systems that improve safety-risk detection and support universal health coverage. WHO also convened the 5th Joint Meeting of the Advisory Committee on Safety of Medicinal Products and the Global Advisory Committee on Vaccine Safety, where experts reviewed a range of medicine and vaccine safety topics. In addition, WHO and the Paul Ehrlich Institut trained study sites in Uganda and Zimbabwe to measure background rates of adverse events of special interest, including Guillain-Barré syndrome, thrombocytopenia and neonatal outcomes.
Photo: WHO
Market Surveillance and Control
Market surveillance and control efforts continued to strengthen global capacity to detect, report and respond to substandard and falsified (SF) medical products, and strengthened laboratory capacity through technical support for national laboratories and expanded regional and global laboratory networks. An Americas regional workshop for SF focal points in Brasília, attended by around 40 participants, reinforced surveillance and reporting capacity and provided a forum to exchange good regulatory practices, and discussions on priority topics on risk-based post-marketing surveillance, online sales, traceability, quality control and the Member State Mechanism. The Global Surveillance and Monitoring System (GSMS) recorded 512 incidents on SF medical products and issued three medical product alerts and one targeted market surveillance report. WHO also released two publications: a risk communication and community engagement toolkit and a digital transformation handbook to modernize national reporting systems.
Photo: WHO
Regulatory Systems Strengthening
WHO established the new Technical Advisory Group on Regulatory Systems Strengthening (TAG-RSS), an independent body of international experts advising on the assessment of national regulatory systems and WHO-Listed Authorities (WLAs). Replacing the former TAG-WLA, the TAG-RSS supports robust, transparent and evidence-based decision-making on regulatory maturity and performance. The group is composed of 20 experts from six WHO regions, with a broad range of expertise relevant to evaluating the performance of candidate WLAs, and a wide knowledge of and experience in regulatory systems for medical products. By bringing together diverse expertise across regions and product areas, it strengthens global confidence in regulatory systems and contributes to WHO's efforts to promote access to quality, safe and effective medical products worldwide. The process will ensure impartiality and transparency in the decision-making process for designating regulatory authorities as WLAs and the determination of maturity levels of regulatory systems.
Photo: WHO
Special Access Programme
The WHO Special Access Programme advanced the Collaborative Registration Procedure (CRP) across several regions. A regulators-only workshop for EMRO countries drew over 80 participants, followed by an industry webinar, while advocacy webinars were held for WPRO countries. In addition, Malaysia and Oman recently joined CRP for prequalified in vitro diagnostics and for prequalified medicines, vaccines and in vitro diagnostics, respectively. Upcoming events include a public consultation on prequalification and Stringent Regulatory Authority/ WHO-Listed Authority CRP guidelines (July–August 2026) and the CRP Annual Meeting on 24–26 November 2026, held mainly online with limited in-person participation at WHO headquarters in Geneva.
Photo: WHO/PAHO
