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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
A WHO-Listed Authority (WLA) is a National Regulatory Authority (NRA) that is recognised as meeting WHO and other internationally recognized regulatory standards and practices. The WLA listing of an NRA by WHO is based on an established global benchmarking and performance evaluation process. Health Sciences Authority (HSA), Singapore; Swiss Agency for Therapeutic Products (Swissmedic); Ministry of Food and Drug Safety (MFDS), Republic of Korea are the first three NRAs to be listed as WHO-Listed Authorities. WHO has implemented a WLA framework for recognising regulatory authorities operating at an advanced level of performance. The recognition of NRAs as WLA listed authority, helps replace or is an alternative for SRA (stringent Regulatory Authority) approval concept for global procurement of medicines. Implementation of the WLA framework is intended to promote access and supply of safe, effective and quality medical products
WHO has established a Global Benchmarking tool (GBT) for classifying regulatory systems according to maturity level, assessing how well a regulatory system is configured to achieve desired results for medicines and vaccines. Recently WHO announced that the Saudi Food and Drug Authority (SFDA), has achieved maturity level four (ML4) for medicines and vaccines regulation, the highest level in WHO’s classification. Singapore and Korea are the other two NRAs with maturity level 4 (ML4). Global Pharma hubs for generic medicines, India and China are at Maturity level 3 (ML3) classification only for Vaccines (not for Medicines), while Turkey, Nigeria, Ghana, Tanzania are at M3 level for both Medicines and Vaccines. (See the list of NRAs at M3 and M4 level)
The WLA performance evaluation with measurement of consistent adherence to international standards and good regulatory practices goes one more step from regulatory classification according to maturity level. NRAs that have attained an overall maturity level 3 (ML3) classification are eligible for consideration as a WLA.
This recognition by WHO is a testimony to the GMP compliance standards ensured by agencies like HAS Singapore and Swiss Medics etc. If CDSCO (India), reaches the same level of standards (ML3 or 4) for Medicines, foreign authorities will be able to accept GMP certificates by CDSCO. This in turn can result in reduced levels of regulatory actions and requirement of audits by foreign agencies like USFDA, European agencies, WHO on Indian drug manufacturers.
I think it is correct
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