Regulatory Focus™ > News Articles > To Boost Trade, China Agrees to Reform Drug, Device Regulations

To Boost Trade, China Agrees to Reform Drug, Device Regulations

Posted 13 January 2015 | By Michael Mezher 

To Boost Trade, China Agrees to Reform Drug, Device Regulations

The governments of the US and China have agreed to several policies that have the potential to reduce barriers to trade for US medical devices and pharmaceuticals sold in China. The agreement comes from discussions between the two countries at the 25th US-China Joint Commission on Commerce and Trade held in Chicago between 16 and 18 December 2014.

Less Red Tape

China has “agreed to streamline [its] regulatory process and cut red tape” for US pharmaceuticals and medical devices, the US Department of Commerce (DOC) said in a press statement announcing the agreement. The DOC explained that the two countries have agreed to the following measures affecting US healthcare products:

  1. "China will accelerate the studying and pushing forward of the reform of the medical device and pharmaceutical regulatory review and approval system, and will make great efforts to eliminate the drug application backlog within 2-3 years.  China’s efforts will include adding personnel, funds, streamlining relevant mechanisms, and increasing the speed of review."
  2. "Applicants who use Multi-Regional Clinical Trial data that includes data from China in order to apply for clinical trial waivers, and whose applications comply with the technical review requirements, can receive clinical trial waivers in China, in order to prevent duplicative testing."
  3. "China will implement measures that allow a drug not marketed in foreign countries to conduct clinical trials in China at the same time it is conducting clinical trials in another country.  Applicants can submit evidence of marketing approval of a pharmaceutical product in another country (i.e. certificate of pharmaceutical product) when applying for the drug license after completing clinical trials."

An Evolving Dialogue

The two countries have agreed to continue the dialogue between their respective regulatory authorities in 2015 by bringing in experts and agency officials “to promote efficient pharmaceutical and medical device regulation and market access.”

These agreements come just one month after the United States Food and Drug Administration (FDA) and the China Food and Drug Administration (CFDA) signed two Implementing Agreements (IAs) which aim to increase collaboration between the two regulatory agencies and “frame the work of [FDA] inspectors” in China. A fact sheet describing the major provisions of the IAs is available from FDA.


Department of Commerce Fact Sheet

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