Pilot Assessments And Improvements At The EMA

March 25, 2011

The EMA has announced a pilot program with the FDA for the parallel assessment of Quality by Design applications, as well as a separate project aimed at improving the agency?s core business.

The EMA has announced a pilot program with the FDA for the parallel assessment of Quality by Design applications, as well as a separate project aimed at improving the agency’s core business.

The pilot with the FDA will commence on Apr. 1, 2011 and run for three years until Mar. 31, 2014, applying to selected applications submitted to both agencies at the same time. Both agencies will separately assess the parts of the applications relevant to QbD, including development, design space and real-time release testing, with regular communication and consultation throughout the process. The aim is to have a common list of questions for the applicant and a harmonised evaluation of responses.

In Europe, the pilot will apply to new marketing authorisation applications and quality-related scientific advice requests; Type II variations may also be included on a case-by-case basis. In the US, the pilot will apply to new drug marketing applications, prior-approval supplements and chemistry manufacturing control meeting requests. The pilot will only include chemical entities, but a press statement added that ongoing consideration would also be given to other areas of collaboration.

A second project was also announced by the EMA this week to enhance the processes of its core business and to help boost the quality of certain applications. According to a statement, the project responds to one of the objectives of the EMA’s previously announced Road map to 2015 initiative.

“The programme aims to improve the efficiency of processes in order to support the agency’s capabilities to deliver sustainable results. The program will initially focus on processes for the authorisation, supervision and maintenance of medicinal products to increase internal efficiency while maintaining quality of opinions and satisfaction of applicants,” said the EMA statement.

Improvements will stem from identification and elimination of internal process complexity. However, the EMA also believes that significant improvements in throughput and lead times can be improved if applications are submitted to the agency in the highest possible standard. To help improve the efficiency of processes, the EMA has said it will provide a prenotification checklist to help applicants submit complete and correct type IA variation notifications, with the aim of raising the quality of these applications.

www.ema.europa.eu