NIH Launches “ClinRegs” Website Aggregating Country-By-Country Clinical Research Regulation
The National Institutes of Health’s (NIH) National Institute for Allergy and Infectious Diseases (NIAID) has launched an online database of country-specific clinical research regulatory information “designed to save time and effort in planning and implementing clinical research.” The website, ClinRegs, provides users with useful comparison capabilities between thirteen countries.
“By providing well-documented, up-to-date regulatory information for multiple countries in a single place, ClinRegs is intended to serve as a central resource and time-saver for persons involved in planning and implementing international clinical research,” the website states.
ClinRegs provides an overview of country-specific regulations in the following topic areas.
- Competent Authority Oversight
- Ethics Committee Oversight
- Clinical Trial Lifecycle
- Sponsorship
- Informed Consent
- Investigational Products
- Specimens
The website currently asks for feedback from users, and NIAID notes that additional topics may be added based on that feedback.
As an example, the Clinical Authority Oversight section for India states, in part:
In India, the Drugs Controller General of India (DCGI), head of the Central Drugs Standard Control Organization (CDSCO), is the competent authority responsible for clinical trial oversight, approval and inspections. The DCGI grants permission for clinical trials to be conducted in India in accordance with the provisions of the DCA, 1940/DCR, 1945 and Schedule Y. The DCGI is also commonly referred to as the Licensing Authority in the Indian regulations.
CDSCO is India’s central regulatory body for pharmaceuticals and medical devices. The DCGI, who directs CDSCO, handles the drug and device regulatory process; he/she is also responsible for registering all imported drugs and new drugs and for overseeing clinical trials. CDSCO functions under the Directorate of General Health Services (DGHS) which is part of the Ministry of Health and Family Welfare (MOHFW).
NIAID has aggregated information from Brazil, China, India, Kenya, Liberia, Malawi, Peru, South Africa, Tanzania, Thailand, Uganda, the United Kingdom, and the United States. Mali, Mexico, Haiti, and Vietnam will be possible additions to the programs, according to NIAID.
The comparator tool provides side-by-side comparisons with countries on your chosen topic. For example, this shows a look at the “informed consent” requirements of both the United Kingdom and the United States.
Given the fact that large pharmaceutical companies operate internationally and must navigate a wide variety of complex clinical regulation, this website is very helpful. Having one master resource such as this can serve to both clarify a company’s obligations, and expedite their understanding of responsibility in one country verses another.