REGIA

REGIA is an open-access digital platform that compiles, organizes, and compares information on regulatory requirements for conducting clinical trials in 22 countries of the Region of the Americas: Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, the Dominican Republic, Trinidad and Tobago, Uruguay, and Venezuela.

REGIA was developed by PAHO’s Regional Program on Bioethics as part of PAHO’s Clinical Trial Accelerator Initiative, which aims to strengthen the efficiency, quality, and impact of clinical trials throughout the Americas.

REGIA promotes transparency and facilitates access to reliable and up-to-date regulatory information on health research in the Region of the Americas. Information is presented in a structured and comparable manner, facilitating the conduct of clinical trials and the analysis of research regulatory frameworks across countries.

REGIA also contributes to strengthening the capacities of stakeholders involved in research, supports the development of research initiatives in the Region, and promotes regional cooperation.

The platform compiles and organizes the current regulations of each of the 22 countries related to clinical trials, including laws, decrees, regulations, resolutions, guidelines, instructions, forms, and other relevant regulatory instruments.

The information is organized into six thematic areas to facilitate navigation, consultation, and comparative analysis:

• Authorities and general framework: bodies responsible for the regulation, review, authorization, and oversight of clinical trials.
• Sponsor roles and obligations: the sponsor’s functions, responsibilities, and regulatory obligations throughout the clinical trial lifecycle.
• Initial authorization of clinical trials: requirements, procedures, and documentation necessary to obtain authorization for a clinical trial.
• Management of the investigational product (IP): provisions related to the importation, manufacturing, labeling, storage, distribution, and handling of investigational products.
• Conduct and closeout of trial: requirements for the reporting and management of adverse events, serious adverse reactions, and other safety reports.
• Additional specific regulations: supplementary provisions applicable to specific situations, such as personal data protection, vaccine studies, biological samples, special populations, or other relevant regulatory requirements.

Each thematic area includes a set of structured questions and answers reflecting specific requirements. The responses are based on the current regulations of each country and are updated periodically.

By selecting questions and answers, users can identify specific regulatory requirements, filter and compare information across countries, and download results in PDF format. 

download questions

The platform is designed to provide a simple and intuitive user experience, with no prior registration required. Users can access regulatory information through various navigation options, even without knowing in advance where the specific requirements or documents they are looking for are located.

REGIA offers three tools to explore and analyze regulatory information:

• Search by country: Enables users to access the complete regulatory profile of each country through direct selection or via an interactive map.
• Comparator: Facilitates the simultaneous analysis of up to three countries by displaying regulatory requirements and characteristics in a comparative format.
• Advanced Filter: Allows users to identify countries that meet the specific requirements selected by the user

REGIA information is updated periodically through review and validation processes with official sources and specialists from participating countries. The platform prioritizes higher-level regulatory instruments and ensures that content reflects only current regulations.

If you would like to report a regulatory update or submit a suggestion, you can contribute to the continuous improvement of the platform through the feedback form, which is accessible via the link located at the bottom of the platform’s homepage.

This platform describes and systematizes the regulations currently in force across the Region; however, it does not necessarily endorse them. PAHO actively works with its Member States in the development and review of their regulations to ensure alignment with the international ethical and regulatory standards established by the Council for International Organizations of Medical Sciences (CIOMS) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), respectively.

The language used in the platform’s questions follows these international standards. The language used in the responses reflects the terminology found in national regulations, which does not always conform to international standards (for example, “research involving human beings,” recognizing that human beings are not merely a location “in” which research is conducted).

Likewise, the content of national regulations is not always fully consistent with international standards. PAHO reiterates the importance of requiring ethical approval for all research involving human participants and authorization from a National Regulatory Authority (NRA) for any clinical trial intended to support the registration of a new medicine or other health products.

These approvals must be granted by separate entities: a Research Ethics Committee (REC) and the National Regulatory Authority (NRA), as explained here: https://www.paho.org/en/documents/infographic-oversight-research