Guangdong Province Taking M88 login Lead in Piloting Drug Evaluation and Approval Mechanism Reform

On November 2, 2012, State Food and Drug Administration (“SFDA”) issued M88 login Reply Regarding Guangdong Food and Drug Administration to Take M88 login 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, M88 login State Council issued M88 login Reply of M88 login 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 M88 login innovative research of traditional Chinese medicine by enterprises in Hengqin Traditional Chinese Medicine Industry Park and of M88 login pilot and trial drug regulatory mechanism reform by Guangdong Province.

In furM88 loginrance of M88 login Reply No. 85 of M88 login State Council, SFDA and M88 login People’s Government of Guangdong Province have on March 27, 2012 entered into M88 login Memorandum of Joint Establishment of Pilot Region of Drug Safety Supervision and Administration by M88 login People’s Government of Guangdong Province and SFDA (M88 login “Memorandum”) with a view to: (i) facilitating M88 login 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 M88 login industrial independent innovation principally by enterprises.

Formulation and Approval of Reform Implementation Plan: In light of M88 login SFDA Reply,SFDA agrees to in joint efforts with Guangdong Province establish drug evaluation institution and implement M88 login 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 M88 login 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 M88 login authority to organize M88 login technique evaluation of and M88 login administrative approval on M88 login transfer applications for new drug technology and drug manufacturing technology by M88 login manufacturing enterprises within Guangdong Province, provided that M88 login approval result shall be reported to SFDA for record. SFDA will issue M88 login Drug Approval Number on M88 login 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 M88 login authority to examine and approve cases in which a Guangdong drug manufacturing enterprise is subcontracted to carry out M88 login production, provided that M88 login approval result shall be reported to SFDA for record.²

It is important to note that M88 login dossiers requirements and work time limit for M88 login above evaluation and approval matters shall still be governed by M88 login relevant provisions of M88 login Administrative Measures for Drug Registration and M88 login Measures for Supervision and Administration on Drug Production (SFDA Decrees No. 28 and No. 14).

Comments:M88 login delegation provided for in M88 login SFDA Reply only applies to drug technology transfer and drug sub-contract production. In spite of M88 login limited application scope, it reflects M88 login trend that SFDA is gradually delegating downstream its examination and approval authority to local authorities against M88 login backdrop of M88 login drug evaluation and approval mechanism reform. Hopefully, M88 login gradual delegation of authority may alleviate M88 login prolonged examination and approval “queuing” period resulted from M88 login centralized drug approval authority and certain positive influence may be generated on drug examination efficiency and drug innovation encouragement.

1. In accordance with M88 login current regulations, SFDA is responsible for M88 login technique evaluation of and M88 login administrative approval on M88 login transfer applications for new drug technology and drug manufacturing technology.

2. In accordance with M88 login current regulations, SFDA is responsible for M88 login acceptance of and approval on M88 login trans-province applications for drug sub-contract production.