Circular of the China Food and Drug Administration on the Matters Relating to Promotion of the Pilot Program for the Drug Marketing Authorization Holder System
Circular of the China Food and Drug Administration on the Matters Relating to Promotion of the Pilot Program for the Drug Marketing Authorization Holder System
Circular of the China Food and Drug Administration on the Matters Relating to Promotion of the Pilot Program for the Drug Marketing Authorization Holder System
Shi Yao Jian Yao Hua Guan [2017] No.68
August 15, 2017
The drug and food administrations in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan Provinces(Cities),
In accordance with the Decision on Empowering the State Council to Carry out the Pilot Program for the Drug Marketing Authorization Holder System in Some Regions and Related Issues promulgated by the National People's Congress and the Circular of the General Office of the State Council on Promulgating the Pilot Program for the Drug Marketing Authorization Holder System (Guo Ban Fa [2016]No.41), the China Food and Drug Administration (the "CFDA") has organized to carry out the drug marketing authorization holder(the "Holder") system pilot program. Since the pilot program is carried out, the local governments in pilot provinces (cities) have formulated the implementing proposals in succession, actively carried out work and achieved the desired effect at different stages. Nevertheless, there is still a gap between overall work progress and the actual requirements. In order to promote carrying out the marketing authorization holder system pilot program and further make exploration in respect of the rights, obligations and legal liability of the Holder, the quality management system in entrusted manufacturing and the responsibility system for the whole manufacturing and marketing chain, cross-regional regulatory coordination between the drug regulators, division of duties and assumption of responsibilities, we hereby notify the matters relating to the pilot program as follows:
I. We shall ensure the assumption of the legal liability by the Holder. The Holder shall be responsible for managing the whole manufacturing and marketing chain and the whole life cycle of drugs and assume the full legal liability for pre-clinical drug study, clinical trials, manufacturing, marketing and distribution and adverse drug reaction monitoring etc. Generally speaking, drug manufacturers, drug R&D institutes and researchers can serve as the Holders. Drug manufacturing and processing enterprises which hold no drug approval number yet obtain their drug manufacturing licenses can be entrusted with the task of manufacturing and processing drugs. The entities and individuals that are entrusted by the Holders with the tasks of the R&D, clinical trials, manufacturing, marketing and distribution of drugs shall assume liabilities as prescribed by laws and regulations and stipulated in agreements. The Holders shall be responsible for the release of drug marketing and assume full liability for the quality of drugs sold on the market and its entrusted manufacturers shall be responsible for manufacturing drugs according to the technology and quality standards under the agreements, releasing products manufactured and be responsible to the Holder for the quality of drugs.
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