China Outlines Plan to Encourage Innovation, Speed Drug Approvals

The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information.

The Council wants the China Food and Drug Administration to establish timelines for approving or rejecting applications by 2018, according to a plan released Aug. 18. The CFDA would also establish a special review and approval system to spur development of innovative drugs to combat AIDS, cancer, major infectious diseases and rare diseases. Small and micro-enterprises would be given approval priority.

Institutions involved in researching and developing new drugs would be allowed to apply for registration of those products, and once approved and transferred to manufacturing facilities, no further appraisal would be required.

The plan also calls for simpler applications so that drugs, their labeling, packaging and materials can be approved simultaneously.

At the same time, transparency around the approval process would increase, with timely release of information on registration applications and drug supply and demand. Sponsors would be informed of the status of application reviews and the public would be able to view and inquire about product approvals.

The Council also wants Chinese hospitals and academic centers to increase their participation in multinational clinical trials that adhere to international standards to gather test data that can be used to support regulatory submissions.

Meanwhile, responsibilities of sponsors, clinical sites and ethics committees to protect study subjects would be strengthened, and the clinical trial process would be more closely scrutinized to ensure data integrity and reliability. Any fraudulent activities concerning research or data would be severely punished, the Council says.

The plan also outlines steps to improve the quality of generic drugs and speed up generic quality conformance evaluations by the end of 2018. Generic drugs that don’t pass a quality conformance assessment would not be reregistered.

Mark Barnes, an attorney with Ropes & Gray, says the measures, which have been put out for public comment, are likely to take effect, as State Council proposals are typically adopted.

The long registration timeline in China has been a sore topic for multinational pharmaceutical companies, and even made it to the senior-level U.S.-China Joint Commission on Commerce and Trade dialogue, says Helen Chen, head of L.E.K. Consulting’s China life sciences practice.

One of the processes rumored to be streamlined is the IND application, which, if adopted, would move China toward a US-style process of approval, she tells IPRM. The duration may be 60 days, compared with 30 days in the U.S., but it’s substantially shorter than the one to two years drugmakers now wait for clinical trial authorization.

Plans that would allow R&D institutions to apply for registration of new drugs could open up the contract manufacturing market in China, Chen notes. This would foster start-ups, which could use CMOs rather than having to raise and invest capital in a manufacturing facility, and would give the larger drugmakers more flexibility, she adds. — Kellen Owings


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