About

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID)’s ClinRegs website is an online database of country-specific, clinical research regulatory information. By providing well-documented and current information in a single place, ClinRegs serves as a central resource and time-saver for persons involved in planning and implementing international clinical research.

Countries and topics are included in ClinRegs based on NIAID’s international clinical research priorities.

Information Available

ClinRegs provides country-specific regulatory information in the following topic areas:

  • Regulatory Authority
  • Ethics Committee
  • Clinical Trial Lifecycle
  • Sponsorship
  • Informed Consent
  • Investigational Products
  • Specimens

The single-country profile view  provides a summary of the requirements and the relevant sources from which the summary is derived, for each topic section.

The comparison view, which is accessible from within a country page, provides a side-by-side view of the topic summaries for two countries. Cited sources are accessible by clicking on the source links.

When available, ClinRegs provides English versions of regulatory documents. English translations from sources other than a regulatory authority are designated “unofficial.” When more than one language is available, you can select from the hyperlinked options. For certain non-English sources, links to Google translations are provided. Google Translate links are for information purposes only and may not always work as expected. ClinRegs does not control the quality or accuracy of translated content. If you require assistance locating specific regulatory information or with questions about the site should contact the ClinRegs team by clicking the Contact Us link at the top of each page.

To receive the latest ClinRegs information, please subscribe to country- or topic-specific email updates via GovDelivery.

Content Development and Maintenance

The ClinRegs team—comprised of regulatory, legal, and policy analysis experts—reviews and analyzes regulatory authority information to develop the website content. To ensure fidelity, accuracy, and consistency, all content is vetted by country-specific subject matter experts and edited for clarity and style. See the Acknowledgements page for a listing of the country experts.

On average, country content is reviewed and, if necessary, updated yearly. However, updates may be issued more frequently, particularly to incorporate substantial, timely changes to country regulations or requirements. We welcome you to share your expertise via the comment button on the right side of the page, or via the Contact Us link at the top of each page.

Broken links are identified and fixed monthly.

Governance

ClinRegs is a NIAID Executive Committee-approved project developed under NIAID’s Barriers to Clinical Research initiative. Management responsibility for ClinRegs resides principally in the Division of Clinical Research (DCR) with guidance from the ClinRegs Steering Group (ClinRegs SG), a subcommittee of the NIAID Clinical Research Subcommittee. Comprised of NIAID divisional representatives with expertise in international clinical research, ClinRegs SG members are responsible for providing input, guidance, and prioritization for the site’s content, features, and functionality based on the interests, needs, and preferences of their respective NIAID divisions. The ClinRegs SG also serves as the site’s change control board.

Internet Browser Compatibility

ClinRegs is optimized for performance in Google Chrome, Microsoft Edge, Safari, Firefox, and Internet Explorer. If you encounter problems with the display or functionality, please let us know by using the Contact Us link at the top of each page.

Disclaimer

Content: Although ClinRegs contains information of a legal nature, it is intended for informational purposes only. It does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction, including the United States. The Federal Register and the Code of Federal Regulations remain the official sources for regulatory information published by the United States. While every effort is made to provide accurate and complete information, the laws, regulations, and guidelines referenced are often complex and may provide more details than are included on this site. Also, since new standards are issued on a continuing basis, NIAID cannot guarantee that this site is free of inaccuracies and reflects the most current information available. Please check with local authorities and/or research ethics committees before commencing research activities.

When a country’s regulatory requirements are not available in English, the content provided is developed using unofficial sources or machine translation services.

Occasionally this site houses country-specific regulatory documents when they are otherwise not available online. Though we strive to provide the most current information available, these documents cannot be guaranteed to be the most up-to-date versions. Also, they may not be Section 508 compliant, in which case you should contact the documents' authors to request accessible versions.

Links to External Websites and Documents: This site contains links to non-U.S. Government websites and documents, which are provided for the convenience of users. Such use does not constitute an official endorsement or approval by NIAID of any external website, document, product, or service. You are subject to the external site's privacy policy when clicking on these links. We are not responsible for Section 508 compliance on other federal or private websites or documents.

Use the symbols below to refine your search
SymbolExplanation
No symbol At least one of the keywords must be present
Search example: serious adverse event
Result: Will contain serious and/or adverse and/or event
+ Leading plus sign indicates that the word must be present
Search example: serious +adverse event
Result: Will contain adverse and may contain serious and/or event
- Leading minus sign indicates that the word must not be present
Search example: serious adverse -event
Result: Will contain serious and/or adverse but won’t contain event
“ ” Exact phrase must be present
Search example: “serious adverse event”
Result: Will contain the phrase serious adverse event
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ClinRegs content is published in English. ClinRegs offers translations of the content through Google Translate, which is an external translation service. ClinRegs does not control the quality or accuracy of translated content and may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages.