APEC Supply Chain Regulatory Harmonization Effort Gaining Traction

The Asia Pacific Economic Cooperation (APEC) organization is developing and implementing a five-year plan cutting across GMPs, GDPs, pharmacy practices and Internet sales that could have a powerful influence on global regulatory harmonization in the pharmaceutical supply chain arena.

In addition to Pacific Rim member countries, other regulatory and standards organizations, including FDA, EMA, USP, Health Canada, EDQM, WHO, Rx-360, and the Nigerian government are participating in the plan, which was sanctioned by APEC in December and is now getting underway.

APEC is a multi-lateral trade setting organization that was founded by 21 Pacific Rim countries with a mission of mitigating unnecessary trade burdens between them.  FDA and Health Canada were among the participants that were instrumental in convincing the multi-national body that the harmonization of pharmaceutical supply chain regulation is an important component in achieving its goals.

At a “Pharmaceutical Supply Chain Workshop” co-sponsored by PDA and FDA in Bethesda, MD in early June, CDER Office of Drug Security, Integrity and Recalls (ODSIR) Regulatory Counsel Mark Paxton provided an update on the progress the group is making and discussed why the effort is important.

Paxton, the FDA representative to the APEC subcommittee looking at drug regulatory harmonization, explained that the scope of the supply chain effort ranges from raw material purchasing to the finished product used by the patient.

“From raw materials to finished product manufacturers and the distribution channels that go forward to the patients, from my perspective [the supply chain] has gotten worse everywhere, not better,” Paxton commented.  “So we want to be very holistic in this.  We do not want to close one gap and just have something else erupt somewhere else.”

He noted that the APEC committee has engaged with industry, and “particularly with Rx-360 membership,” to understand the issues that are not always obvious to regulators.

“Understand that the FDA is based in the US,” Paxton said.  “We have not had a long history of working overseas on a lot of different things that multi-national companies see every day.  But because of globalization, we have to have an understanding of what is going on because we have bad product coming into the United States all of a sudden.  We are very much alerted to that.  In fact my office, ODSIR, was formed just for that purpose.”

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