Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

Documents posted here were prepared for national regulatory authorities, regional pharmaceutical advisors, regulatory networks and associated stakeholders to provide timely information around development and regulatory approval of COVID-19 related diagnostics, treatments and vaccines.

It is important to highlight that the situation and context have been rapidly evolving so information in previous updates may now be outdated.

Please note that it may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means without the permission of the World Health Organization.

Regulatory updates

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The WHO Emergency Committee on COVID-19 in its latest meeting expressed concern that the pandemic is being mischaracterized as coming to an end even though...

The WHO Emergency Committee on COVID-19 in its latest meeting expressed concern that the pandemic is being mischaracterized as coming to an end even though...

As addressed by Dr Tedros at the opening of the World Health Assembly on 24th May, all Member States are asked to support to vaccinate at least 10% of...

Annexes to Regulatory Update

The vaccine pillar, COVAX, of the ACT accelerator has established a Regulatory Advisory Group (RAG) which is co-led by WHO and CEPI. The RAG has members...

The vaccine pillar, COVAX, of the ACT accelerator has established a Regulatory Advisory Group (RAG) which is co-led by WHO and CEPI. The RAG has members...

The vaccine pillar, COVAX, of the ACT accelerator has established a Regulatory Advisory Group (RAG) which is co-lead by WHO and CEPI. The RAG has members...