In order to realize the APAC mission, RA-EWG will share information regarding the challenges faced in each economy and transmit all necessary proposals to the stakeholders.
Furthermore, the pharmaceutical associations of each economy will propose solutions to their respective governments and stakeholders regarding the pharmaceutical-related challenges in each region. All the activities to reach the goal are to be undertaken by the strategic approach including a step-by-step approach.
RA-EWG Leader’s Message
Areas of the RA-EWG focus are: 1) Implementing APAC Good Submission Practice (GSubP) as industry initiative. 2) Supporting promotion of Good Review Practice (GRevP) by making practical proposals from industry perspectives. 3) Promoting regulatory convergence of NDA requirements in Asia.
The RA-EWG has been advocating the concept of good registration management, under which execution of both Good Submission Practices (GSubP) and Good Review Practices (GRevP) by the applicants and the reviewers, respectively, will enhance the performance of both submission and review, leading to efficient and quick drug registration/approval.
Members are basically the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) member associations in the following economies:
R&D-based Pharmaceutical Association in China
The Hong Kong Association of the Pharmaceutical Industry
Organization of Pharmaceutical Producers of India
International Pharmaceutical Manufacturers Group
Japan Pharmaceutical Manufacturers Association
Korea Pharmaceutical Manufacturers Association
Korean Research-based Pharmaceutical Industry Association
Pharmaceutical Association of Malaysia
The Pharmaceutical and Healthcare Association of the Philippines
Singapore Association of Pharmaceutical Industries
International Research-Based Pharmaceutical Manufacturers Association
The Pharmaceutical Research and Manufacturers Association