Statement from Global Medicines Regulators on the Value of Regulatory Reliance
The globalization of rapidly evolving health technologies requires joint efforts by National Regulatory Authorities (NRAs), to ensure that patients around the world have early access to safe and high-quality medicines.
One important approach for international action is regulatory reliance, which is a mechanism to strengthen regulatory capacity, to improve health systems nationally and internationally, to increase the availability of medicines, to save financial resources and to use human resources more strategically.
The World Health Organization (WHO) also supports regulatory reliance[i][ii], and defines it as “the act whereby a NRA in one jurisdiction may take into account and give significant weight to assessments performed by another authority or trusted institution, or to any other authoritative information in reaching its own decision. The relying authority remains independent, responsible and accountable regarding the decisions taken, even when it relies on the decisions and information of others”[iii].
Reliance is built on trust between regulators and can be unilateral or mutual. Within this context, reliance can be strengthened by ensuring that regulatory decisions of NRAs are made based on consideration of robust scientific evidence that demonstrates a favourable benefit-risk profile and assures the quality of the products.
Reliance can involve direct collaboration between authorities or institutions in order to share regulatory information such as assessment or inspection reports or scientific opinions. Formal tools can be used to support reliance, such as confidentiality commitments/agreements or memoranda of understanding.
Global relevance and key principles
Regulatory processes can be optimized and duplication of efforts can be minimized through reliance. In addition, scientific expertise can be leveraged, leading to more fruitful and robust decision making, and enhancing the capacity of regulators. Consequently, reliance can also allow efficient allocation of resources by NRAs and improve access to medicines.
The COVID-19 Pandemic has emphasized the importance of regulatory cooperation and information sharing which are important elements of reliance. ICMRA emphasizes the relevance of reliance in streamlining responses and facilitating efforts to multiple regulatory activities during public health emergencies. For example, ICMRA published reports, described agreements on common approaches from workshops, and discussed regulatory considerations related to the development of SARS-CoV-2 vaccine candidates and treatments among its members.
ICMRA recognises that each NRA will decide the levels and approaches of reliance suitable for their context, and that the adoption of regulatory reliance must follow overarching principles. These principles include sovereignty of decisions, transparency of processes and standards, consistency of products and practices, legality of procedures and mandates at national levels, competency of all stakeholders involved, and universality as reliance applies to all NRAs irrespective of their levels of maturity and resources. While there is a relevant role for reliance mechanisms, they should not replace the importance of continuously developing expertise within NRAs.
Call on Stakeholders
ICMRA expresses its support for reliance as a regulatory strategy and commits to work with medicines regulatory authorities towards the adoption of best practices when using reliance approaches, in order to make best use of available resources while ensuring that medicines have a favourable benefit-risk profile and are quality assured. ICMRA invites stakeholders to cooperate and to engage in the efficient use of reliance.
- ICMRA calls on NRAs to continually assess regulatory capacities; to establish clear and transparent decision-making processes; to participate in international harmonization and regulatory convergence; to engage with the development of international regulatory collaboration and cooperation; to share information on their practices to strengthen regulatory capacities with other NRAs; and to seek the adoption of reliance mechanisms. These initiatives work to build robust and efficient regulatory systems and, consequently, to further develop trust.
- ICMRA calls on the WHO to provide technical support to NRAs; to gather information from NRAs worldwide and explore areas of reliance; to support global distribution of medicines; to provide guidance documents, benchmarking, as well as regulatory tools to facilitate the implementation of reliance practices; and to establish and maintain a framework to evaluate NRAs and assess their regulatory performance.
- ICMRA calls on the pharmaceutical industry to comply with legal and technical requirements; and to ensure the consistency and quality of the products and the completeness of the documentation submitted to different NRAs. Companies can also benefit from reliance and the efficiency of regulatory processes through transparent collaboration.
We all have a role to play in building a strong reliance system that can benefit health regulation worldwide. ICMRA[iv] therefore encourages continued cooperation among NRAs and highlights the benefits that regulatory reliance can bring in expediting access to medicines that have a favourable benefit-risk profile and are of high quality.
[i] WHO, 2020. Draft Good Reliance Practices in regulatory decision-making for medical products: high-level principles and considerations. Working document QAS/20.851/Rev.1. https://www.who.int/docs/default-source/medicines/norms-and-standards/current-projects/qas20-851-rev-1-good-reliance-practices.pdf
[ii] PAHO/WHO, 2019. Regulatory Reliance Principles: Concept Note and Recommendations. http://iris.paho.org/xmlui/bitstream/handle/123456789/51549/PAHOHSS19003_eng.pdf?sequence=1&isAllowed=y
[iii] WHO, 2020. Draft Good regulatory practices for regulatory oversight of medical products. Working document QAS/16.686/Rev.3 https://www.who.int/docs/default-source/medicines/norms-and-standards/current-projects/qas16-686-rev-3-good-regulatory-practices-medical-products.pdf
[iv] ICMRA is an international executive-level coalition of key regulators from every region in the world. It provides a global strategic focus for medicines regulators and gives strategic leadership on shared regulatory issues and challenges. Priorities include coordinated response to crisis situations. Members of the ICMRA include: Therapeutic Goods Administration (TGA), Australia; National Health Surveillance (ANVISA), Brazil; Health Products and Food Branch, Health Canada (HPFB-HC), Canada; China National Medical Products Administration (NMPA), China; European Medicines Agency (EMA) and European Commission - Directorate General for Health and Food Safety (DG - SANTE), European Union; French National Agency for Medicines and Health Products Safety (ANSM), France; Paul-Ehrlich-Institute (PEI), Germany; Health Product Regulatory Authority (HPRA), Ireland; Italian Medicines Agency (AIFA), Italy; Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Ministry of Food and Drug Safety (MFDS), Korea; Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Mexico; Medicines Evaluation Board (MEB), Netherlands; Medsafe, Clinical Leadership, Protection & Regulation, Ministry of Health, New Zealand; National Agency for Food Drug Administration and Control (NAFDAC), Nigeria; Health Sciences Authority (HSA), Singapore; Medicines Control Council (MCC), South Africa; Medical Products Agency, Sweden; Swissmedic, Switzerland; Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom; Food and Drug Administration (FDA), United States and the World Health Organization as an observer. Associate members include Austrian Medicines and Medical Devices Agency (AGES), Danish Medicines Agency, Israel Office of Medical Technology, Health Information and Research (MTHIR), Poland Office of Registration of Medicinal Products and Biocidal Products (URPLWMiPB), Russia Roszdravnadzor and Spain Agencia Española de Medicametos y Productos Sanitarios (AEMPS).