The European Medicines Agency (EMA) and FDA have agreed on a two-year extension of their joint pilot program for the parallel evaluation of quality by design (QbD) applications.
This follows the success of the first phase of this program initiated in April 2011 during which the agencies assessed in parallel the QbD elements of one marketing authorization application and several scientific advice requests submitted by medicines developers.
"Both agencies found these parallel assessments extremely useful and reached agreement on a wide range of QbD aspects leading to the publication of two guidance documents for the industry. Further guidance is being developed and is expected to be published in 2014," said EMA in a press release.
Quality by design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of the medicines; these concepts are described in the guidelines of the International Conference on Harmonization (ICH), ICH Q8, Q9, Q10, and Q11.
The objective of this parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on QbD aspects and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the United States.The program is open to selected procedures, including applications for initial marketing authorzations, Type-II variations and scientific advice. Participation in the pilot is voluntary. Applicants and sponsors should express their interest in participating in the programme to both agencies at least three months prior to submission of an application.
Applicants volunteering for this parallel assessment benefit from a harmonized evaluation of their application and receive a common list of questions/information requests or an agreed list of issues to be addressed from the two agencies for the parts of the application subject to the pilot.
With the agreement of the applicants, experts from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) participate as observers in the program.