The EMA has established a task force of European experts with specialized knowledge in vaccines, infectious diseases and other relevant expertise to contribute to the global response to the threat of the Zika virus infection. This group will be available to give advice on any scientific and regulatory matters for the research and development of medicines or vaccines against the virus.
The EMA task force was established following the declaration by the World Health Organization (WHO) on Feb. 1 that the Zika virus outbreak is a Public Health Emergency of International Concern. There are currently no vaccines or medicines to protect from or treat Zika virus infection that are approved or undergoing clinical studies.
The Agency is encouraging medicines developers to contact EMA if they have any promising projects in this area. EMA will also proactively reach out to companies already planning to work on investigational vaccines and offer scientific and regulatory advice. EMA will review any new information as soon as it becomes available to support the response to this widening public health crisis.
During a health emergency such as the Zika virus outbreak, EMA works closely with European bodies, including the European Commission and the European Center for Disease Prevention and Control (ECDC) and with international partners such as WHO and other international regulators from affected countries.
There are already a number of existing mechanisms and tools which can be used to help speed up the R&D of medicines and vaccines in the context of an emerging viral disease such as Zika.
Companies may seek scientific advice from EMA on the appropriate tests and studies required in the development of their products. Early and regular interaction with the Agency can significantly speed up the development of medicines.
The European Article 58 procedure also provides an opportunity to give a scientific opinion on treatments intended primarily for use in non-E.U. countries, while collaborating closely with WHO and experts from those countries.