The RQHC is comprised of four Regional Focus Groups; the membership of each is made up of regulatory professionals with subject matter expertise and experience working in the EMEA, North America, Latin America and Asia-Pacific regions. RQHC A-P RFG’s goals are to identify topics and issues of concern to health authorities in the region, to identify opportunities for ISPE to provide input, guidance, and scientific/technical support on evolving regulatory issues and concerns for the specific region, and to conduct and deliver regional regulatory projects.
The RQHC A-P RFG has recently been refreshed with new members and a renewed focus on issues in the Asia-Pacific region. The RQHC A-P RFG will focus on all countries in the Asia-Pacific region and will connect with ISPE Affiliates in Australia/New Zealand, India, Indonesia, Japan, South Korea, Malaysia, Philippines, Singapore, and Thailand, as well as with the new ISPE Shanghai organization on China-related topics
The refreshed RQHC A-P RFG has compiled a list of ‘hot topics’ to address, including:
- regulatory harmonization between the AP countries and ICH
- the requirement in some AP markets to register excipient and packaging suppliers
- import testing requirements
- reliance pathways
- acceptance of ‘global’ drug substance starting materials
- prior approval post-approval variations required for minor changes
- renewal requirements
- more widespread acceptance of science- and risk-based approaches to drug development
- and many others!
In order to develop nuanced strategy, initial meetings will focus upon individual countries. The RQHC A-P RFG recently focused on Vietnam and challenges that industry is experiencing there, such as the level of detail required on GMP certificates, segregation of cytostatic materials, and CPP requirements. We will focus next on Malaysia.
Going forward, we’ll meet with colleagues in the AP affiliates, strengthening our bridges for greater impact, and participate in upcoming AP affiliate meetings and conferences. Our goal is to move towards global harmonization, which will accelerate patient access to important medicines all over the globe, and especially in the AP region.
If these goals and interests resonate with you, there is room to join your colleagues on the RQHC A-P RFG. If you are interested in learning more about joining the group, please reach out to Carol Winfield, ISPE Sr. Director of Regulatory Operations. We look forward to having you join us!
