China Approves Drug Marketing Authorization Holder Pilot Plan

China’s State Council issued an effective notice, dated May 26, 2016, formally authorizing a trial plan for a new drug marketing authorization holder (MAH) system for 10 provinces: Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Sichuan. Pharmaceutical research institutions and individual researchers in these provinces can submit an application for clinical trials or marketing authorization registration. Applicants obtaining marketing authorizations and approval documents can become MAHs and take legal responsibility for clinical trials, production, and marketing, something previously not allowed, PaizaBio said in a press statement.

According to PaizaBio’s chief commercialization officer, David Deere, who oversees the company’s aseptic fill/finish operations in China, this is significant as it approves the use of contract manufacturing organizations (CMOs) to produce drugs in China. Per the State Council’s announcement, MAHs without manufacturing capabilities for production must contract with a CMO with qualification to produce approved drugs. MAHs with manufacturing capabilities can use their own facility to produce drugs or may contract production with qualified CMOs. MAHs or applicants can submit additional information, alternate MAH, and change CMO during and after the approval process.

The announcement is a clarification of policy reforms announced by China’s Food and Drug Administration (cFDA) in late 2015 designed to accelerate the regulatory review of new drugs and expand options for manufacturing approved drugs, PaizaBio wrote. The new policies, which went into effect December 1, 2015, represent major changes in China’s drug development and commercialization policies and address accelerating the high-volume backlog of drugs awaiting review and approval by the cFDA and fostering domestic clinical drug development and manufacturing to international technical and quality standards. Chinese and Western pharmaceutical companies are impacted.

Drugs approved before this plan include those having the quality and efficacy consistency to the original drugs and drugs from manufacturing companies that have the approval documents relocate or emerge with other companies. The MAH trial period takes effect on this date of plan issuance until November 4, 2018, at which time participants approval documents will remain valid for the full approval period as issued.

Source: PaizaBio