European authorities recognised for leading medicine regulatory oversight

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A total of 33 regulatory authorities have been granted designation as World Health Organization (WHO) Listed Authorities under the WLA framework.

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines”.

This new approval “marks a significant progress” in improving access to safe, effective and quality medicines and vaccines, remarked Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

WHO confirmed that the newly approved WLAs include:

• The European Medicines Regulatory Network (EMRN), which is made up of the European Commission (EC), the European Medicines Agency (EMA) and the medicines regulatory authorities of 30 countries.
• The US Food and Drug Administration (FDA)

Now, overall, the WLA listing comprises of 36 regulatory authorities from 34 Member States.

The World Health Organization technical advisory group on WHO Listed Authorities (TAG-WLA) found these agencies demonstrated “consistency of advanced performance” in meeting the international standards and best regulatory practices, according to WHO.

Dr Yukiko Nakatani, Assistant Director-General, Access to Medicines and Health Products and Assistant Director-General, Antimicrobial Resistance ad interim explained that “as WLAs, these agencies can be relied on to reassure quality and safety of medicines and vaccines to streamline processes, optimise resources, and expedite access to medicines and vaccines”.

Importance of holding WLA status

“We congratulate the listed authorities for this recognition and commend WHO for their leadership in this area. Regulatory reliance serves as a beacon of efficiency and collaboration, enabling regulatory authorities worldwide to leverage each other’s evaluations while maintaining accountability for patient safety,” Janis Bernat, Director, Scientific and Regulatory Affairs at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) shared.