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WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

Posted 03 June 2019 | By Zachary Brennan 

WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

As part of a shift from the term “stringent regulatory authority” to “WHO-Listed Authority” (WLA), the World Health Organization (WHO) in May discussed some of the details of an upcoming draft framework for evaluating and publicly designating regulatory authorities as WLAs.

The concept note defines a WLA (including Maturity Level 3 WLAs and Maturity Level 4 WLAs), explains the process for applying for and being designated as a WLA and the process for finalizing the definition and the procedures for putting the framework into place.

“The designation of a regulatory authority as a WLA is ultimately meant to promote access, supply and the intended use of safe, effective and quality medicines and vaccines,” WHO says. The framework will also help to guide international and national procurement decisions on medical products and increase the pool of regulators contributing to the WHO Prequalification program.

The proposed framework uses an evaluation tool (known as Global Benchmarking Tool or GBT) to generate and analyze the evidence of regulatory system performance and allow for the public listing of regulators as WLAs. WHO is also developing a system for evaluating the performance of regional regulatory networks or systems.

“Should it become evident during the course of the combined benchmarking-performance evaluation exercise that the regulatory authority is unlikely to meet requirements for listing within a 6 – 12 month timeframe from the start of the benchmarking-evaluation process, depending on the scope of designation, the authority would be invited to reapply at a later time once identified areas for improvement have been addressed,” the note says.

WHO also says it may prioritize eligible requests based on the estimated impact on the regional or global supply of quality assured medicines or vaccines. In addition, listings on the WHO website will indicate product categories (generic and/or new medicines and/or vaccines) or regulatory functions (such as regulatory inspections) for which a designation applies.

As far as the future timeline, WHO intends to publish a draft WLA policy document similar in scope to the concept note by the end of July 2019 and draft operational guidance documents by the end of August 2019 to enable implementation of the WLA framework.

“It is expected that the introduction of the WLA framework will begin with a pilot phase in the first quarter of 2020,” WHO says.


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