Drugs
【Update Date:2020-10-13】unit:藥品組
The Life Science Innovation Forum (LSIF) was established by the leaders of Asia-Pacific Economic Cooperation (APEC) to lead APEC initiatives on health and health science innovation. LISF gathers and engages representatives from the government, industry and academia, forming a tripartite forum that focuses on creating the policy the environment for life sciences innovation.
The Regulatory Harmonization Steering Committee (RHSC) was formed under the auspices of APEC LISF in 2009 to promote strategic approach to regulatory harmonization among APEC economics. RHSC links the network of regulatory experts from the regulatory agencies, industry and academia in APEC economies with the vision in achieving greater regulatory convergence.
To achieve greater regulatory convergence among APEC economies, seven Priority Working Areas (PWAs)(Fig.1) are identified by RHSC as key areas for pharmaceutical and medical devices. Each PWA is led by champion(s) endorsed by RHSC to lead development via roadmaps. Taiwan Food and Drug Administration (TFDA) of Chinese Taipei co-leads the ‘Good Registration Management (GRM)’ PWA with Japan MHLW/PMDA. Under this PWA, TFDA and MHLW/PMDA focus on promoting efficient registration process for medical products by enhancing and promoting the concept of Good Review Practices (GRevP) and Good Submission Practices (GSubP), in order to benefit patients with timely access of medical products which are both efficacious and in good quality.
For more details of the APEC LSIF-RHSC, please refer to the official website:
https://www.apec.org/RHSC
▲ Fig 1_ PWA champions
Priority Working Areas (PWAs)
Champions
Good Registration Management (GRM)
1.Food and Drug Administration, Chinese Taipei (TFDA)
2.Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Advanced Therapy
1.Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan
2.Ministry of Food and Drug Safety (MFDS), Korea
3.US Food and Drug Administration (US FDA), United States
Biotherapeutic Products
1.US Food and Drug Administration (US FDA), United States
2.BIO (Interim)
Global Supply Chain Integrity
US Food and Drug Administration (US FDA), United States
Medical Device
Multi-Regional Clinical Trial and Good Clinical Practice Inspection (MRCT&GCP Inspection)
1.Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan
2.Food and Drug Administration, Thailand (Thai FDA)
Pharmacovigilance
Ministry of Food and Drug Safety (MFDS), Korea