China Makes Strides Toward Western Drug, Device Standards

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By Mark Melnicoe

The latest series of announcements from China’s Food and Drug Administration will streamline and accelerate approvals for drugs and medical devices in a step being hailed as the most important yet in the country’s health-care modernization drive.

Four draft circulars issued May 11-12 are aimed at expediting reviews of drugs and devices, expanding the infrastructure for clinical trials, improving enforcement actions and establishing a patent-linkage system with improved intellectual property (IP) protections. Comment on the drafts is being taken until June 10.

“The four documents proposed many critical policies that will bring China much closer to Western countries in the regulatory oversight of drugs and medical devices,” Shaoyu Andrew Chen, partner and managing director of the China food and drug practice at Covington & Burling in Shanghai, told Bloomberg BNA in a May 17 email. “These proposed policies will substantially speed up the marketing approvals of imported and domestic drugs or medical devices, and provide some meaningful IP and data protection from a regulatory perspective.”

Approval Times May Be Cut in Half

It’s a welcome step for multinational drug and device companies, which are seeing booming sales in China but have long bristled at the country’s maze of rules and regulations for importation, licensing and approvals. Chen said approvals in China can take as long as five years after they have gained approval in their home countries, but that should change.

“The proposed policies, together with the proposed decisions to change the registration of imported drugs that were issued on March 17, 2017, could shorten the approval time very significantly, in some cases by 50 percent or more,” he told Bloomberg BNA, predicting that the timeline can be cut to “zero to three years.”

A U.S.-based industry group also commented on the steps taken by China. “The proposals appear to be in keeping with China’s ambition to become a world leader in medical innovation,” Mark Grayson, a spokesman for the Washington-based Pharmaceutical Research and Manufacturers of America, told Bloomberg BNA in an email. “In combination with other reforms, the proposals could benefit patients in China and around the world.”

Four Big Takeaways

Katherine Wang, a partner at Ropes & Gray in Shanghai, cited four main takeaways affecting multinational health-care companies:

  •  conditional approvals for drugs or devices treating life-threatening diseases or addressing critical unmet medical needs;
  •  automatic clinical trial approvals after a 60-day stay period if China’s Center for Drug Evaluation or Center for Medical Device Evaluation don’t reject or issue deficiency notices;
  •  conditional admission of foreign study data for marketing authorizations; and
  •  for drug manufacturers specifically, permission to initiate phase I studies in China, the introduction of patent linkage, and reinforcement of data exclusivity.
Taken together, the four drafts “represent the most significant efforts that the Chinese government has taken to reform the health-care industry,” Wang told Bloomberg BNA in a May 18 email.

Some Deregulation for Clinical Trials

In addition to speeding reviews and approvals of drugs and devices (Circular No. 52), the draft policies aim to “deregulate the conduct of clinical trials to encourage innovation (Circular No. 53), enhance post-market supervision throughout a product’s entire life cycle (Circular No. 54), and protect the rights of innovators (Circular No. 55),” Wang wrote in a client alert May 14.

Drugs and devices that offer new solutions for treating life-threatening diseases or addressing critical unmet medical needs can be eligible for conditional approvals, as long as early and mid-stage study data can indicate their efficacy and predict their clinical values, Wang wrote.

In addition, “drugs and devices that offer new solutions for treating rare diseases, if already approved outside China, can be eligible for conditional approvals.”

She noted that Circular 53 eases government controls on clinical trials.

Foreign Trials Data Allowed

“Foreign clinical data can be admitted to support registration of drugs and medical devices in China, as long as (a) the trials comply with Chinese regulations, (b) the trials pass CFDA’s on-site audits, and (c) applicants can provide clinical data to prove that no ethnicity difference affects the product’s safety and efficacy,” Wang wrote.

She also noted that a Marketing Authorization Holder (MAH) system that has been piloted in 10 provinces for more than a year will be applied nationwide. The MAH system allows drug researchers to commercialize their products while retaining their marketing rights without the burden of doing the manufacturing themselves. Previously, only drug manufacturers could obtain regulatory approvals—a system seen as an obstacle to innovation because it forced researchers and developers to make big investments in manufacturing facilities if they wanted to get their inventions to market.

The latest circulars build on a years-long trend that has seen the central government push for greater integrity of clinical trials data, faster approvals for drugs and devices, and better protection of patents and trademarks to help spur innovation.

Rules May Take Effect Soon

After the comment period ends June 10, China’s FDA could move fairly quickly on its own, practitioners suggested.

“Arguably, many of the proposed policies will require formal amendment to the laws and regulations, and it could take at least a few months or even years to complete the formal legislative amendment process,” Chen told Bloomberg BNA.

But he also said that the CFDA and other agencies “have used ’policies’ or ’decisions’ as a vehicle to implement changes to the law without going through the formal legislative amendment process.”

“Policies can be issued and take effect much sooner than the formal legislative amendment process,” Chen said. “Accordingly, some of the proposed policies or decisions could take effect very soon, either on a rolling basis or all at once, especially if no significant objections are raised by various stakeholders during this public comment period.”

To contact the reporter on this story: Mark Melnicoe in Shanghai, at correspondents@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

For More Information

The China FDA's Circular 52 on speeding reviews and approvals is in Chinese at http://www.sfda.gov.cn/WS01/CL0087/172567.html.Circular 53 detailing fewer rules on clinical trials is at http://www.sfda.gov.cn/WS01/CL0087/172568.html.Circular 54 on enhancing post-market supervision is at http://www.sfda.gov.cn/WS01/CL0087/172569.html.Circular 55 protecting patents and other rights of innovators is at http://www.sfda.gov.cn/WS01/CL0087/172606.html.

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