APEC Members See Increased Regulatory Convergence
Posted 19 August 2019 | By
Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile.
The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in:
- Sharing information (from 16 APEC economies to 19 economies)
- Establishing confidentiality commitments (from 12 economies to 15)
- Sharing good manufacturing practice (GMP) certificates (from 15 to 17 economies)
- Establishing mutual recognition agreements (MRAs) (from 10 to 12 economies)
- Streamlining the requirements for certificates of pharmaceutical products (CPPs) (from seven to eight economies)
- Allowing a single license to cover multiple sites (from nine to 13 economies).
But the number of APEC economies of the 21 total members joining international regulatory convergence initiatives over the last decade has skyrocketed.
For instance, those economies joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has increased from two to seven, while the number participating in the Pharmaceutical Inspection Cooperation Scheme (PIC/S) has increased from four to 13 economies. And the number joining the International Pharmaceutical Regulators Programme (IPRP) has increased from six economies to nine.
“Measurement leads to improvement. More regulatory convergence enhances the well-being of our people who rely on safe and effective medical products – and we look forward to achieving more progress,” said Michelle Limoli of the US Food and Drug Administration, who serves as co-chair of the forum’s Regulatory Harmonization Steering Committee
APEC also notes how it uses 12 training centers across seven member-country sites to train hundreds of regulators on multi-regional clinical trials, biotech products, global supply chain integrity, advanced therapies and medical devices.
The 21 APEC member economies are the US, Australia, Brunei Darussalam, Canada, Chile, China, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Papua New Guinea, Peru, the Philippines, Russia, Singapore, Republic of Korea, Chinese Taipei, Thailand and Vietnam.