China pilot eyes easier marketing authorization

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A pilot program to widen eligibility for drug marketing authorization approval by the China FDA will help small and innovative companies get drugs to market at a lower cost.

The Marketing Authorization Holder (MAH) pilot, recently approved by the State Council, allows researchers and smaller operations approved to apply for and hold China FDA approvals in the absence of in-house manufacturing facilities--marking a departure from the requirement, according to a note from law firm Ropes & Gray on the pilot.

The change, if adopted widely after the pilot ends in November 2018, will allow innovative drug developers to hire contract manufacturers and save them the expense of full-blown operations, the law firm noted.

"The MAH system demonstrates China’s strong momentum to unleash innovation in the pharmaceutical sector," the law firm said. "Both local and foreign players should consider leveraging the regulatory flexibility of the pilot program to acquire or spin off assets and to utilize GMP-certified contract manufacturing arrangements. Contract manufacturers are also advised to revisit potential opportunities in the Chinese market."

Policymakers in China have expressed concern that drug development costs could lead to higher prices for approved innovative products developed locally. To give some breathing room, the MAH pilot allows firms life science development hubs the chance to qualify.

The rules state that an individual holder of marketing authorization must be a Chinese citizen, and some medicines are excluded.

- here's an update from Ropes & Gray

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