Chinese regulators easing multi-region clinical trial hurdles

China's move to spur drug approvals is seen as a breakthrough on accepting multi-region clinical trial processes as part of an effort to clear nearly 20,000 medicine approval requests pending and allowing more innovative therapies to reach the market, according to a briefing by the country's State Council, or cabinet.

The Aug. 18 release was sparse in detail, but did offer a timeline and general direction for policy. In related statements on the CFDA website and one carried in China Daily from the Development Research Center of the State Council, some details were fleshed out.

At stake for many innovative firms was the status of data gathered in multi-regional clinical trials, or MRCT, and their acceptance by the CFDA.

In July, CFDA officially joined the interim management committee of the International Coalition of Medicines Regulatory Authorities (ICMRA), signaling its readiness to be part of the global discussion on MRCTs and clinical data quality. But last year, drugmakers were concerned that CFDA may not accept MRCT data in whole and require local studies in approval applications as well.

For many companies, MRCTs are the only pathway for drugs that are not yet approved overseas to enter China, but enrolling Chinese patients has been a hurdle as domestic rules on recruitment vary.

Still, regionally the MRCT pathway has grown for market entry in countries such as South Korea, which is seeing a surge after moving to accept the process in 2010. The overall number of Asia-based patients in such trials is now as much as 30%, compared to only around 5% nearly a decade ago.

The State Council statement and related releases made it clear that simultaneous clinical trials of novel drugs and the data gathered from global trials would be accepted in the process of whether to approve innovative therapies.

In addition, the State Council said that overseas drugmakers can ask the CFDA to expedite reviews if a drug addresses unmet needs in areas like oncology, though the price cannot be more than in the drug's home market or countries similar to China.

"China has decided to reform its appraisal and approval system for drugs and medical instruments with the aim of improving drug safety and quality and encouraging innovation," the State Council release said.

"The relevant authorities will make efforts to strike a balance between the number of registration applications received and those that are approved by the end of 2016," the statement said. "They will also ensure that, by 2018, every application will be approved or rejected within a certain time limit. In order to achieve these goals, the State Council requested that the approval standards for medicines should be improved by adjusting the classification of drug registration. The appraisal and approval process of innovative drugs will be accelerated, including drugs to treat AIDS, cancer, serious infectious and rare diseases."

The State Council also noted that medical devices are included in the broad push on approvals--and CFDA has been busy since the start of the year on many fronts in drugs and devices that detail the procedures for filing clinical trial applications to seeking to expand staff and office resources.

- here's the release from China's State Council
- and verification and review notices from CFDA (Chinese)
- plus an article in China Daily