CLICK HERE for APACRM-related literature
Mission of APACRM
To expedite the development and availability of superior therapeutic products, such as regenerative medicine products, to Asian patients.
Participating members of the APACRM:
ABLE, Association of Biotechnology Led Enterprises (India);
BPIPO, Biotechnoogy and Pharmaceutical Industries Promotion Office (Taiwan);
CARM, The Council for Advanced Regenerative Medicine (Korea);
CMBA, China Medicinal Biotech Association (China);
FIRM, Forum for Innovative Regenerative Medicine (Japan);
RMAF, Regenerative Medicine Acceleration Foundation (Korea);
SAPI, Singapore Association of Pharmaceuticals Industries (Shingapore);
Purpose
To promote harmonization and optimization of the regulations on Regenerative Medicine products among Asian countries and territories
To maximize the opportunities in Asian markets, and ensure the creation of a market that is comparable to those in North America and Europe.
This international platform should serve as a base for the development of a common scientific understanding of the nature of regenerative medicine through establishing a dialogue between the industry and health authorities to identify common challenges. It is also expected to help expedite the distribution of these advanced therapeutic products in the Asian markets.
Working Level Meeting
WG1: To investigate the differences in non-clinical data packages required for Cellular Therapy Products in Asian countries/regions and to extract regulatory science issues & limitations
WG2: Regulation on starting cell and ancillary materials for cellular therapy products in Asian countries/regions and risk-based approach
WG3: Points to Consider for Regulations on Clinical Trials for AAV-based Gene Therapies in 6 Asia Countries