Early dialogue with the EMA is key to success for drug approvals, says Agency

“Companies that request and follow scientific advice provided by the European Medicines Agency have a 90% success rate at the stage of marketing-authorization application compared with a 30% success rate for companies that do not request scientific advice,” explains Spiros Vamvakas, head of scientific advice at the EMA.

Scientific advice is one of many tools available to micro, small and medium-sized companies (SMEs) to support them in the development of their medicines and increase their chance of success at the marketing authorization stage. These tools promote interaction and dialogue with the Agency from the very early stages of medicine development and throughout the medicine’s lifecycle.

Support to medicine development is a priority for the Agency. This is reflected in the Agency’s new organization structure, which aims to consolidate its support to development through the creation of its Human Medicines Research and Development Support Division.