The Medicines and Healthcare products Regulatory Agency (MHRA), as a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), has pledged its support to the World Health Organization (WHO) in countering the Zika outbreak. The WHO has declared that Zika constitutes a Public Health Emergency of International Concern.
ICMRA brings together 21 medicines regulators from every region in the world, and its members are working together to fight against Zika virus disease, building on ICMRA’s collaborative work on Ebola.
Priorities are to support the rapid development of diagnostic tests, including reference material to assure comparability of results, as well as vaccines and treatments against Zika virus disease. This will be achieved through enhanced international collaboration and by providing scientific advice in the development of such products. Any investigational medical products must be evaluated for quality, safety and efficacy and it is the regulator’s role to ensure that the benefits of any new medical product outweigh its risks.
As there is no specific vaccine or treatment currently available, and development of these is at an early stage, ICMRA members are exchanging information on the emerging data about Zika virus infection links to serious health concerns and will work together to review possible investigational vaccine and treatment options, with the goal of expediting their development. They will also ensure the regulatory processes are as efficient as possible to support the development and delivery of effective and safe medical products to populations in need worldwide.