Regulatory Reliance
What is reliance?
Reliance, or regulatory reliance, is a practice adopted by health regulatory authorities to optimize and accelerate their decision-making processes. It refers to the possibility of a national regulatory authority considering and using, in whole or in part, the assessments, inspections, and decisions of other trusted regulatory authorities or international bodies, while always respecting their sovereignty and independence.
The use of reliance does not mean delegating responsibilities, but rather recognizing the value of the work already done by other authorities, contributing to the more efficient use of resources, reducing rework, and promoting timely access to safe, effective, and quality products.
Official definition according to the WHO
“Reliance: the act whereby a regulatory authority in one jurisdiction takes into account, and gives significant weight to, assessments performed by another regulatory authority or trusted institution, or to any other authoritative information, in reaching its own decision. The relying authority remains independent, responsible and accountable for the decisions taken, even when it relies on the decisions, assessments and information of others.”
(WHO Good Regulatory Practices: guidelines for national regulatory authorities for medical products, 2021)
- Difference between reliance, recognition, and work-sharing
- Reliance: An authority uses, in whole or in part, the technical work of another trusted authority as part of its own decision-making process. The final decision remains with the authority using reliance.
- Recognition: The authority officially recognizes the decisions of another regulatory authority without the need to reevaluate the data. In this case, the decision is accepted in its entirety and there may be no further analysis.
- Work-sharing: Regulatory authorities work collaboratively and simultaneously on assessments, inspections, or other processes, dividing tasks in order to achieve harmonization and efficiency gains.
- Advantages of reliance
- For regulatory authorities:
- Improved efficiency of regulatory processes.
- Optimization of human and financial resources.
- Reduction of duplication of efforts.
- Strengthening of institutional and technical capacities.
- Promotion of international alignment and regulatory harmonization.
In practice: Anvisa actively participates in initiatives such as the International Medical Device Regulators Forum (IMDRF), the Medical Device Single Audit Program (MDSAP), and PIC/S (Pharmaceutical Inspection Cooperation Scheme), reinforcing its alignment with global best practices.
- For the productive sector:
- Reduced timeframes for product analysis and approval.
- Greater predictability and transparency in regulatory processes.
- Facilitation of simultaneous access to different markets.
- Stimulation of innovation and competitiveness.
In practice: The adoption of reliance mechanisms for medicines and medical devices allows companies to bring innovations to the Brazilian market more quickly, without compromising technical evaluation.
- For society:
- Faster access to safe, effective, and high-quality medicines, vaccines, and medical devices.
- Strengthening confidence in health regulation processes.
- Improved response to public health emergencies.
- Contribution to more efficient and equitable health systems.
In practice: The use of reliance was essential to Anvisa's response to the COVID-19 health emergency, enabling rapid access to essential products in a context of high global demand.
Legal and Regulatory Foundations in Brazil
Anvisa's adoption of reliance practices is in line with international guidelines and is supported by legal and regulatory foundations at the national level.
WHO guidelines on reliance
The World Health Organization (WHO) is one of the leading international references in promoting reliance as a good regulatory practice. The WHO encourages the use of this strategy, especially by regulatory authorities seeking to strengthen their capacities and optimize resources.
Legal and regulatory frameworks that allow Anvisa to adopt reliance
In Brazil, the adoption of reliance mechanisms is supported by various legal and regulatory instruments, which grant Anvisa the authority to use information from other regulatory authorities and international organizations in its decision-making processes.
- Law No. 9,782/1999 – Establishes the National Health Surveillance System and defines Anvisa's powers, including the possibility of technical cooperation with national and international entities.
- Law No. 13,411/2016 – Provides for the prioritization of analyses and may be applied in situations where reliance contributes to procedural speed.
- Law No. 14,313/2022 – Regulates Anvisa's activities in the analysis of health products and explicitly provides for the possibility of using technical opinions issued by other authorities.
- Specific Anvisa regulations (RDCs) – Contain provisions that formalize the use of reliance in certain regulatory contexts.
Reliance is formally provided for in Anvisa regulations
- Registration of medicines - RDC 741/2022 e IN 289/2024
- Clinical trials of medicines - RDC 945/2024 e IN 338/2024
- Inspection and GMP certification for medicines- RDC 741/2022 e IN 292/2024
- Registration of medical devices (risk classes III and IV) - RDC 741/2022 e IN 290/2024
- Inspection and GMP certification for medical devices - RDC 741/2022, RDC 497/2021 e RDC 687/2022
- Food assessment - RDC 741/2022 e IN 344/2025
Partner authorities and organizations
Anvisa maintains a strategic cooperation network with regulatory authorities and international organizations that share high standards of quality, transparency, and technical rigor. These partnerships are fundamental for the adoption and strengthening of reliance practices, contributing to more agile and secure decisions that are aligned with international best practices.
Mutual recognition, the exchange of technical information, and participation in multilateral initiatives reinforce confidence in regulatory processes and expand the Agency's capacity to protect the health of the Brazilian population.
The Agency uses technical information and reports from these authorities in evaluation, registration, inspection, and post-market processes.
Anvisa also signs bilateral technical cooperation agreements with foreign regulatory authorities, which establish formal bases for the exchange of confidential information, the use of technical data, the holding of regular meetings, and the implementation of joint actions.
These instruments enable the concrete application of reliance and demonstrate Anvisa's commitment to international cooperation and regulatory convergence.
Equivalent Foreign Regulatory Authorities (AREEs) recognized (by regulatory processes)
- Registration of medicines, vaccines and biological products
- Reliance mechanism - Optimized review based on approval documents
- Applicable regulations - RDC 741/2022 e IN 289/2024
- AREEs
- European Medicines Agency (EMA - EU);
- Food and Drug Administration (FDA - USA);
- Health Canada;
- Medicines and Healthcare products Regulatory Agency (MHRA - UK);
- Pharmaceuticals and Medical Devices Agency (PMDA - Japan)*;
- Swissmedic (Switzerland);
- Therapeutic Goods Administration (TGA - Australia);
- World Health Organization - Prequalifcation of Medical Products (WHO PQT)
* The Pharmaceuticals and Medical Devices Agency (PMDA) is AREE with regard exclusively to product quality information.
- Registration of active pharmaceutical ingredients (APIs)
- Reliance mechanism - Optimized review based on approval documents
- Applicable regulations - RDC 741/2022 e IN 289/2024
- AREEs
- European Medicines Agency (EMA - EU);
- European Directorate for the Quality of Medicines & Healthcare (EDQM - EU);
- Health Canada;
- Pharmaceuticals and Medical Devices Agency (PMDA - Japan)*;
- World Health Organization - Prequalifcation of Medical Products (WHO PQT)
* The Pharmaceuticals and Medical Devices Agency (PMDA) is AREE with regard exclusively to product quality information.
- Clinical trials of drugs, vaccines, and biologics
- Reliance mechanism - Optimized review based on approval documents
- Applicable regulations - RDC 945/2024 e IN 338/2024
- AREEs
- European Medicines Agency (EMA - EudraGMDP - EU);
- Food and Drug Administration (FDA - USA);
- Pharmaceuticals and Medical Devices Agency (PMDA - Japan)
- Inspection and GMP certification for medicines, vaccines, biologics and APIs
- Reliance mechanism - Acceptance of inspections or audit reports for certification
- Applicable regulations - RDC 741/2022 e IN 292/2024
- AREEs - Authorities or entities that are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), including EMA**
Austria – Austrian Federal Office for Safety in Healthcare;
Belgium – Federal Agency for Medicines and Health Products;
Bulgaria – Bulgarian Drug Agency (BDA);
Canada – Heath Canada (HC);
Croatia – Agency for Medicinal Products and Medical Devices of Croatia (Halmed);
Cyprus – Pharmaceutical Services (CyPHS);
Czech Republic – State Institute for Drug Control (SÚKL) and Institute for State Control of Veterinary, Biologicals and Medicines (ISCVBM);
Denmark – Danish Medicines Agency (DKMA);
Estonia – State Agency of Medicines (SAM);
European Union – European Medicines Agency (EMA);
Finland – Finnish Medicines Agency (FIMEA);
France – French National Agency for Medicines and Health Products Safety (ANSM) e Agency of Food, Environmental & Occupational Health Safety (ANSES);
Germany – Federal Ministry of Health (BMG) and Central Authority of the Laender for Health Protection regarding Medicinal Products and Medical Devices (ZLG);
Greece – Greek National Organisation for Medicines (EOF);
Hungary – National Center for Public Health and Pharmacy (NCPHP);
Iceland – Iceland Medicines Agency (IMA);
Ireland – Health Products Regulatory Authority (HPRA);
Italy – Italian Medicines Agency (AIFA);
Japan – Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA);
Latvia – State Agency of Medicines (ZVA);
Liechtenstein – Office of Healthcare (AG);
Lithuania – State Medicines Control Agency (SMCA);
Malta – Malta Medicines Authority (MMA);
Mexico – Federal Commission for the Protection Against Sanitary Risks (COFEPRIS);
Netherlands – Health and Youth Care Inspectorate (IGJ);
Norway – Norwegian Medical Products Agency (NOMA);
Poland – Chief Pharmaceutical Inspectorate (CPI);
Portugal – National Authority of Medicines and Health Products, IP (Infarmed, IP);
Romania – National Agency for Medicines and Medical Devices of Romania (NAMMDR);
Saudi Arabia – Saudi Food and Drug Authority (SFDA);
Singapore – Health Sciences Authority (HSA);
Slovakia – State Institute of Drug Control (SIDC);
Slovenia – Agency for Medicinal Products and Medical Devices (JAZMP);
South Korea – Ministry of Food and Drug Safety (MFDS);
Spain – Spanish Agency of Medicines and Medical Devices (AEMPS);
Sweden – Swedish Medical Products Agency (MPA);
Switzerland – Swiss Agency for Therapeutic Products (Swissmedic);
Taiwan – Taiwan Food and Drug Administration (TFDA);
Turkey – Turkish Medicines and Medical Devices Agency (TMMDA ou TITCK);
Ukraine – State Service of Ukraine on Medicines and Drugs Control (SMDC);
United Kingdom – Medicines & Healthcare Products Regulatory Agency (MHRA);
United States of America – U.S. Food and Drug Administration (US FDA)
** The European Medicines Agency (EMA), in the position of PIC/S Associated Partner Organisation, with recognized equivalent Guides, is classified as a member of the PIC/S in the context of IN 292/2024.
- Registration of medical device (risk classes III and IV)
- Reliance mechanism - Optimized review based on approval documents
- Applicable regulations - RDC 741/2022 e IN 290/2024
- AREEs
- Health Canada;
- Food and Drug Administration (FDA - USA);
- Ministry of Health, Labour and Welfare (MHLW - Japan) and Pharmaceuticals and Medical Devices Agency (PMDA - Japan);
- Therapeutic Goods Administration (TGA - Australia)
- Inspection and GMP certification for medical devices
- Reliance mechanism - Acceptance of inspections or audit reports for certification
- Applicable regulations - RDC 741/2022, RDC 497/2021 e RDC 687/2022
- AREEs
- Auditing Organizations recognized by the Medical Device Single Audit Program (MDSAP);
- National regulatory authorities of the Mercosur member states
- Food assessment
- Reliance mechanism - Optimized review based on approval documents
- Applicable regulations - RDC 741/2022 e IN 344/2025
- AREEs
- Codex Alimentarius;
- Bundesinstitut fur Risikobewertung (BfR - Germany);
- European Food Safety Authority (EFSA - EU);
- Food and Drug Administration (FDA - USA);
- Food Standards Australia New Zealand (FSANZ)