OVERVIEW OF THE FUNCTIONS OF THE NATIONAL REGULATORY AUTHORITY (NRA) FOR MEDICAL PRODUCTS ACCORDING TO WHO’S BENCHMARKING TOOL

Abstract

The National Regulatory Authority for Medical Products (NRA) plays an important role in ensuring the quality, safety and effectiveness of vaccines, drugs and medical biological products. The NRA system is implemented by the World Health Organization (WHO) according to the updated Global Benchmarking Tool (GBT) (version V) with 9 functions including criteria to ensure the quality, safety and effectiveness of medical products circulating on the market and are evaluated through 4 levels: 1, 2, 3, 4 (level 4 is the highest level). ). The 9 functions of the system include: RS function - National Regulatory System, MA function - Registration and marketing authorization, VL function - Vigilance, MSC function - Market Surveillance and Control, LI Function - Licensing establishment, RI Function - Regulatory inspection, LT Function - Laboratory access testing, CT Function - Clinical trial’s oversight and LR Function - NRA Lot release.