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New Circular Further Enhancing the Development of the Market Authorization Holder Regime

China Insight - Life Sciences

The China Food and Drug Administration (“CFDA”) promulgated a new circular (2017) No.68 related to the promotion of a drug market authorization holder regime (“MAH Regime”) work on 21 August 2017 (“New Circular”).

The MAH Regime is a pilot regime launched out by the CFDA under its circular (2016) No. 41 in 2016. The MAH Regime will be implemented until 4 November 2018. According to the Circular (2016) No.41, as for the drugs which fall into the scope of pilot drugs in this Circular, it is possible for a drug research institute or a drug manufacturer located in one of the pilot regions (including Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, “Pilot Regions”) or a person engaged in the research and development in the Pilot Regions to become a market authorization holder of a drug to be registered in China. The applicant can submit the drug clinical trial application and drug market authorization application documents in order to obtain the market authorization approval for a drug that it develops, although the applicant itself may not meet the related drug manufacturing requirements. To manufacture the approved drug by this MAH applicant, the applicant shall delegate the manufacturing of the pilot drug to a qualified Chinese manufacturer who has obtained the drug manufacturing license. Before the implementing of this MAH Regime, only the companies which had the relevant drug manufacturing licenses were able to apply for the market authorization approval. Therefore, the MAH Regime under this circular (2016) No. 41 is aimed at encouraging more parties to be involved in the development and research of drugs in China although they do not have the relevant manufacturing licenses as requested under the law of the PRC .

The New Circular is aimed at further improving the work under the Circular (2016) No.41 and encouraging the authorities in each of the Pilot Regions to explore and find out more feasible ways regarding the liabilities of the MAH applicant, the legal liabilities in the whole process of manufacturing and sales as well as the cross-region supervisions by the local food and drug administration (“FDA”) located in different Pilot Regions.

The New Circular provides for the following rules:

1. Emphasis on the legal liability of the MAH

2. Centralizing of market authorization approvals within a group

3. Relocation

4. Transfer of market authorization approval 

5. Multi-sites entrustment

6. Distribution of drug by the MAH 

7. Pharmacovigilance

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Portrait of Nicolas Zhu
Nicolas Zhu