2012.11.16 ZHANG, Wei、Zhang, Dayin
On November 2, 2012, State Food and Drug Administration (“SFDA”) issued the Reply Regarding Guangdong Food and Drug Administration to Take the Lead in Piloting Drug Evaluation and Approval Mechanism Reform (Guo Shi Yao Jian Zhu Han [2012] No. 148) (“SFDA Reply”).
Policy Background: On July 14, 2011, the State Council issued the Reply of the State Council on Policies Relating to Hengqin’s Development (Guo Han [2011] No. 85) (“Reply No. 85”), which allows Hengqin of Zhuhai to implement preferential policies more special than those of Special Economic Zones, including those policies in support of the innovative research of traditional Chinese medicine by enterprises in Hengqin Traditional Chinese Medicine Industry Park and of the pilot and trial drug regulatory mechanism reform by Guangdong Province.
In furtherance of the Reply No. 85 of the State Council, SFDA and the People’s Government of Guangdong Province have on March 27, 2012 entered into the Memorandum of Joint Establishment of Pilot Region of Drug Safety Supervision and Administration by the People’s Government of Guangdong Province and SFDA (the “Memorandum”) with a view to: (i) facilitating the exploration in drug regulatory mechanism reform by Guangdong Province, (ii) formulating and perfecting a drug evaluation and approval mechanism encouraging innovation and with clear-cut orientation, and (iii) motivating the industrial independent innovation principally by enterprises.
Formulation and Approval of Reform Implementation Plan: In light of the SFDA Reply, SFDA agrees to in joint efforts with Guangdong Province establish drug evaluation institution and implement the pilot and trial drug evaluation and approval mechanism reform in Guangdong. Guangdong Food and Drug Administration (“Guangdong FDA”) will formulate detailed implementation plan and submit the same to SFDA for approval before implementation.
Delegation Downstream of Examination and Approval Authority:
1. Transfer Applications for New Drug Technology and Drug Manufacturing Technology. Guangdong FDA is delegated with the authority to organize the technique evaluation of and the administrative approval on the transfer applications for new drug technology and drug manufacturing technology by the manufacturing enterprises within Guangdong Province, provided that the approval result shall be reported to SFDA for record. SFDA will issue the Drug Approval Number on the basis of Guangdong FDA’s approval result.1
2. Application for Drug Sub-Contract Production. Except for biological products and traditional Chinese medicine injections, Guangdong FDA is delegated with the authority to examine and approve cases in which a Guangdong drug manufacturing enterprise is subcontracted to carry out the production, provided that the approval result shall be reported to SFDA for record.2
It is important to note that the dossiers requirements and work time limit for the above evaluation and approval matters shall still be governed by the relevant provisions of the Administrative Measures for Drug Registration and the Measures for Supervision and Administration on Drug Production (SFDA Decrees No. 28 and No. 14).
Comments: The delegation provided for in the SFDA Reply only applies to drug technology transfer and drug sub-contract production. In spite of the limited application scope, it reflects the trend that SFDA is gradually delegating downstream its examination and approval authority to local authorities against the backdrop of the drug evaluation and approval mechanism reform. Hopefully, the gradual delegation of authority may alleviate the prolonged examination and approval “queuing” period resulted from the centralized drug approval authority and certain positive influence may be generated on drug examination efficiency and drug innovation encouragement.
1. In accordance with the current regulations, SFDA is responsible for the technique evaluation of and the administrative approval on the transfer applications for new drug technology and drug manufacturing technology.
2. In accordance with the current regulations, SFDA is responsible for the acceptance of and approval on the trans-province applications for drug sub-contract production.
