Regulation and prequalification

Quality-assured, safe and effective medicines, vaccines and medical devices, including in-vitro diagnostics are fundamental to a functioning health system. Equally important is strengthening regulation, including post-marketing surveillance, and to eliminate substandard and falsified medicines, and developing international norms and standards so that countries worldwide can regulate health products and technologies consistently. 

It is also vital to ensure access to safe, effective and quality health products, a function performed by WHO Prequalification. It works in close cooperation with national regulatory agencies (NRAs) and other partner organizations to make quality priority medical products available for those who urgently need them. It aims to  ensure that medicines, vaccines and other health products are quality-assured, safe, effective and accessible to all populations.

Helping NRAs fulfil their mandate is therefore of critical importance. It is in this context that the South East Asia Regulatory Network (SEARN) was set-up to develop and strengthen regulatory collaboration, convergence and reliance in the WHO South-East Asia Region over shared regulatory issues and challenges, and build capacity and enable national regulatory authorities to fulfil their mandate and better safeguard public health.      

For more information, including for regulatory updates on COVID-19, please visit: WHO regulation and prequalification