Regulatory & Scientific Affairs

The EVM Regulatory Working Group contributes to create a supportive regulatory environment in Europe to accelerate the vaccine access to patients without undermining the efficacy, safety and quality of the product.

The vaccine industry is highly regulated. Vaccine development is a complex and time-consuming process. On average it takes 12 to 15 years to develop a new vaccine. Before a new vaccine is approved for release on the market, a stringent regulatory procedure to assess quality, efficacy and safety must be undertaken. In Europe the legal framework for the registration of pharmaceutical products is established by the European Union. - For more information click here
 
 

EVM contributions

European Medicines Agency
 
  >> EVM comments on The European Medicines Agency Road Map to 2015 : The Agency’s Contribution to Science, Medicines, Health- April 2010