Pak, Indian drug regulatory authorities not on WHO list

ISLAMABAD: The World Health Organization (WHO) has approved designation of 33 national and regional regulatory authorities as WHO Listed Authorities (WLAs) that can be relied on for fulfilling the highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines.

The drug regulatory authorities of both Pakistan and India were not among the WLAs, it emerged on Monday. The listing makes a total of 36 regulatory authorities from 34 member states now designated as WLAs since the launch of the initiative in March 2022.

The newly approved WLAs include the US Food and Drug Administration (US FDA) and the European Medicines Regulatory Network (EMRN), which is composed of the European Commission, the European Medicines Agency (EMA) and the medicines regulatory authorities of the 30 countries including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany (Federal Institute for Drugs and Medical Devices & Paul-Ehrlich-Institute), Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.

Furthermore, the Health Sciences Authority (HSA) of Singapore, which was previously designated as a WLA in October 2023, was approved for an expanded scope of functions. “Today marks a significant progress in our collective efforts to improve access to safe, quality and effective medicines and vaccines. With leading regulatory authorities joining our list, we are stronger and more united to improve access to quality, safe and effective medicines and vaccines for millions more people,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

“I would like to congratulate all agencies designated as WLAs for their investment and commitment to the quality and safety of medicines and vaccines. My thanks also to our experts for their diligent work to implement a transparent and evidence-based assessment throughout the evaluation process”.

The decision is based on the recommendation by the WHO technical advisory group on WHO Listed Authorities (TAG-WLA) following WHO performance evaluations confirming consistency of advanced performance by these authorities in line with international standards and best regulatory practices for ensuring the quality, safety and efficacy of medicines and vaccines.

“This crucial expansion of the WLA framework is a transformative milestone in the global public health regulatory landscape,” said Dr Yukiko Nakatani, Assistant Director-General, Access to Medicines and Health Products and Assistant Director-General, Antimicrobial Resistance ad interim.

“As WLAs, these agencies can be relied on to reassure quality and safety of medicines and vaccines to streamline processes, optimize resources, and expedite access to medicines and vaccines”.

WHO approval for US FDA and EMRN includes all regulatory functions for the product streams of medicines – including multisource (generics) and new medicines (new chemical entities), biotherapeutics and similar biotherapeutic products – and vaccines.

WHO approval for HSA includes an additional regulatory function of market surveillance and control. With this inclusion, HSA’s WLA status now covers all other regulatory functions, for the product stream of medicines – including multisource (generics) and new medicines (new chemical entities) and biotherapeutics and similar biotherapeutic products.

Attaining WLA status signifies not only compliance with these standards but also a commitment to continuous improvement and excellence in regulatory oversight – a commitment consistently demonstrated by the EMRN, HSA and US FDA. There are a few stringent regulatory authorities pending evaluations following their expressions of interest in being assessed for WHO Listed Authorities designation. The Drug Regulatory Authority of Pakistan (DRAP) version could not be obtained despite repeated attempts.