EMA Highlights: Europe to support Zika trials
by Gary Finnegan: The European Medicines Agency has set up a task force on Zika virus in an effort to accelerate the development of new medicines and vaccines against the disease. The group includes experts in infectious disease, vaccines and other specialists with relevant knowledge on the threat of Zika fever.
The move came in response to the World Health Organisation’s declaration in early February that the Zika outbreak is a public health emergency of international concern. There are currently no vaccines or medicines to protect against or treat Zika virus infection – and no clinical trials are yet in progress.
The EMA is keen to hear from medicines developers with promising products in this area and the task force is expected to proactively reach out to companies working on investigational vaccines. Scientific and regulatory advice will be made available in an effort to bring candidate vaccines and drugs into trials as quickly as possible.
The Agency says it is working closely with the European Commission, the European Centre for Disease Prevention and Control (ECDC) and with international partners such as WHO, as well other international regulators from affected countries.
A number of existing mechanisms and tools are already in place which can be used to help speed up the research and development 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 regulator said in a statement.
In addition, Article 58 of the European Treaty provides an opportunity to give a scientific opinion on treatments intended primarily for use in non-EU countries, while collaborating closely with WHO and experts from those countries.