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. ClinRegs is a free and publicly available informational resource and does not provide direct consulting or regulatory support services.
Information Available
Countries and topics are included based on NIAID’s international clinical research priorities.
Country-specific regulatory information is organized by the following topic areas:
The single-country profile view provides a summary of the requirements for each topic section. The comparison view provides a side-by-side view of the topic summaries for up to four countries.
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.
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.