EMA to provide full fee waivers for scientific advice applications from developers of medicines/vaccines against novel COVID-19

The European Medicines Agency (EMA) provides full fee waivers for scientific advice applications from developers of potential therapeutics (to treat the disease) or vaccines (to prevent the disease) against the novel coronavirus disease (COVID-19).

Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing 2019-ncov@ema.europa.eu.

In a first round of discussions, EMA can provide preliminary informal comments and feedback on the development. This will then allow the Agency to identify the products which are mature enough to benefit from fast-track scientific advice, to guarantee best use of this tool.

In the context of the COVID-19 pandemic, with this fast-track scientific advice, the Agency can give developers prompt guidance and direction on the best methods and study designs to generate robust information on how well a medicine or vaccine works and how safe it is.

Since the beginning of the outbreak, the Agency has organised teleconferences with several developers of potential medicines and vaccines against COVID-19. Member States are kept updated on these activities. EMA is also working closely with international regulatory authorities.

EMA is actively supporting the World Health Organization’s (WHO) activities on the prioritisation and analysis of available evidence. Most potential therapeutics initially identified in this context are repurposed agents (i.e. medicinal products already authorised for another purpose) or investigational agents that are or will be investigated for treatment and in some cases for prophylaxis against the disease. EMA’s priority is to accelerate the approval of safe and effective therapeutic candidates to treat people infected by the virus as soon as possible.

Vaccine development is still at an early stage. There are no existing vaccines that could be repurposed to work against the new virus. Timelines for vaccine development are difficult to predict at this point, but it is currently estimated that the first clinical trials will not start before April/May 2020. This means that it will take several months before candidate vaccines are ready for larger clinical studies. Once there is sufficient information available, EMA is ready to assess any applications for marketing authorisation within the shortest possible timelines.

EMA has a range of support measures that can help to facilitate and speed up the development of medicines, which in addition to fast-track scientific advice includes the PRIME scheme, the accelerated assessment, and conditional marketing authorisation procedures. Adequate demonstration of quality, safety and efficacy is expected in order to support the authorisation of medicinal products duly taking into account the context of a global health emergency.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=121787&sid=2