The Asia-Pacific Economic Cooperation (APEC) group recently declared a goal to align regulatory processes for medical devices and pharmaceutical products by 2020. APEC consists of 21 countries, including the US, China, Australia, and South Korea.
The initiative is called the “Strategic Framework for Regulatory Convergence in the Medical Products Sector”. It is outlined in three phases. Phase I will identify each country’s needs in building capacity for developing and implementing regulatory practices. Phase II will cultivate the resources and expertise needed to fulfill those needs. Phase III will comprise of a periodic cycle of assessment, implementation, and reporting, aided by APEC’s regulatory evaluation template.
Participation in the initiative is voluntary. The Framework seeks to promote countries to adopt harmonized regulatory guidances. Pharmaceutical products will follow guidelines from a harmonization body between the US, European Union, and Japan. Medical devices will follow guidelines from the Global Harmonization Task Force.
Regulatory convergence is likely to be a major priority for Asia’s medical products sector in 2012. The APEC framework joins the Trans-Pacific Partnership as the latest initiatives with components specifically addressing the healthcare industry.