APEC Moving Toward 'Regulatory Convergence' in Effort to Safeguard Drugs, Improve Manufacturing

Posted 13 May 2014 | By Alexander Gaffney, RAC 

An international organization which counts most of Asia as members says it and its members will be committing to a joint, multi-year initiative intended to improve medical product manufacturing and the security of the medical product supply chain.

In an announcement on 12 May 2014, the Asia-Pacific Economic Cooperation (APEC) group said its membership had committed to a "greater alignment of policies safeguarding pharmaceuticals, medical devices and biomedical goods"-a commitment the members said was "critical" to ensuring the health of their respective citizens.

"There is considerable variation in medical product manufacturing, distribution, and import-export practice requirements, not to mention differences in the oversight of things like internet pharmacies which are proliferating," said Ryan MacFarlane, co-chair of the APEC Life Sciences Innovation Forum, in a prepared statement. "Regulatory gaps, in and across economies, create opportunities for bad actors to interject unregulated products into the marketplace."

APEC said its goal is to work toward a "regulatory convergence" of practices and standards by 2020, with an emphasis on examining existing regulatory approaches and identifying best practices to adopt across the Asia-Pacific region.

The group is also apparently working with the US Food and Drug Administration. Mark Paxton, a compliance official in the agency's Office of Drug Security, Integrity and Recalls, noted that keeping substandard, counterfeit, misbranded and adulterated products off the market is a common challenge faced by all regulators.

"What we're asking each other is, 'What are the holes and what do we need to do to fill them to increase assurance levels about product quality, safety and efficacy?'" Paxton said. He also explained that APEC member nations are trying to balance international best practices along with the costs of compliance, which developing nations may be less able to bear relative to non-APEC economies.

An update on the initiative will be published by APEC in August 2014, its notice said.

APEC member economies include Australia, Canada, China, South Korea, Mexico, Russia, the United States, and Japan. There are 21 member economies in all.

APEC Announcement

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles