Asia-Pacific Group Targets 2020 for Medicines Regulatory Harmonization

The 21 APEC countries, which include Australia, China, Hong Kong, Russia and South Korea, to name a few, recently agreed on a goal to align their regulatory review of medicines and medical devices by the end of the decade.

APEC — the Asia-Pacific Economic Cooperation group — wants to reduce trade barriers to medical products by developing a website with links to countries’ customs websites, providing information in English as well as the country’s other languages; develop a database of nation-by-nation legal, regulatory and technical requirements for small business exporters; and clarifying how to register intellectual property.

Meanwhile, the European Medicines Agency and FDA plan to step up cooperation on good manufacturing practice (GMP) inspections, moving from information-sharing and joint inspections to outright reliance on one another’s results.

The initiative, now underway, could cut the number of GMP inspections drugmakers face on both sides of the Atlantic.

If your business is global — and most are these days — you need to keep up with just this type of regulatory change, and know what’s in the works in the countries you do business with. Regulatory bodies across the globe are constantly changing and updating compliance or harmonization guidelines — so don’t be left behind. With a copy of FDAnews Guide to International Pharma Regulation: 2012 Edition you’ll have a quick reference to these ever-changing international regulations.

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