The European Medicines Agency (EMEA) has introduced a new scientific advice procedure to help improve efficiency in the face of a continuous increase in the number of requests and meetings with applicants.
The EMEA said the new framework, due to come into effect on July 1, would allow it to deliver feedback more quickly, which in turn would “help sponsors to develop new medicines in a faster and more effective manner, [and] ultimately, help to speed up access of patients to innovative new medicines.”
The number of advice procedures acted on by the EMEA’s Scientific Advice Working Party has nearly doubled in the last four years, according to the agency.
Among the changes laid out are an enlargement of the SAWP to 25 members from 22, broader scope for requesting scientific advice and for follow-up requests, and a new commitment to respond to queries with 40 to 70 days.
In addition, the EMEA’s internal and external advisors will also get involved earlier in the pre-submission phase of an application, the advice procedure will be made more transparent, and the EMEA secretariat will provide oversight to ensure consistency in the advice given.
More details of the ‘New Framework for Scientific Advice & Protocol Assistance’ document are available here.
