Health desk – 2 May 2021: The World Health Organization (WHO) recently issued two documents, which are essential for strengthening the regulatory system activities of countries, including regulatory cooperation, convergence and transparency. Dr. Malingra Simon, Assistant Director-General for Access to Medicines and Healthcare Products of the World Health Organization, said: “Now, more than ever, there is a need for effective supervision of medical products through the implementation of good regulatory practices in response to the global pandemic. Current regulatory oversight challenges.” Reliance and cooperation between regulatory agencies is essential to facilitate the emergency authorization of Covid-19 sanitary tools and to respond quickly in the event of suspected side effects. ”
The nine principles proposed in this document-legality, consistency, independence, impartiality, proportionality, flexibility, clarity, efficiency and transparency-are relevant to all institutions responsible for the supervision of medical products, regardless of their resources ,complexity and regulatory model.
Practical guidelines and other tools (such as a global repository of dependent methods) will facilitate the implementation of the two high-level documents. They are also completing a series of documents that the WHO has issued to guide member states to establish an effective regulatory system, especially the recently released WHO guidelines on implementing a quality management system for national regulatory agencies.