Following the promulgation of the Decision of the Standing Committee of the National People’s Congress on Authorizing the State Council to Carry out the Pilot Drug Marketing Authorization Holder System in Certain Regions and Relevant Issues on November 4, 2015 by the Standing Committee of the National People’s Congress (“First Decision”), the Standing Committee of the National People’s Congress recently promulgated on October 26, 2018, a second Decision of the Standing Committee of the National People’s Congress on Extending the Pilot Period of Authorizing the State Council to Carry out the Pilot Drug Marketing Authorization Holder System in Certain Regions ("Second Decision").
We summarize below the key points of the Second Decision.
1. Extension of Pilot Period
- Pilot Period stipulated in the First DecisionAccording to the First Decision, the pilot drug marketing authorization holder system shall be implemented in ten pilot areas in China, including Beijing, Tianjin, Hebei Province, Shanghai, Jiangsu Province, Zhejiang Province, Fujian Province, Shandong Province, Guangdong Province and Sichuan Province. The drug research and development institutions, scientific research personnel and drug manufacturers in these ten pilot areas are allowed to hold drug marketing approval (“MAH Holder System”).According to the First Decision, the pilot period of the MAH Holder System shall be three years starting from the date of promulgation of the First Decision, i.e. November 5, 2015. The pilot period expired on November 4, 2018.
- Extension of Pilot Period by the Second DecisionOn November 4, 2018, the last day of the pilot period as decided in the First Decision, the Standing Committee of the National People’s Congress promulgated the Second Decision to extend the pilot period for another year. The MAH Holder System continues to apply in the above ten pilot areas till November 4, 2019.
2. Integration between the MAH Holder System and the Revision of the Drug Administration Law of the People’s Republic of China (“PRC”)
- The Drug Administration Law of PRC is in the progress of revision. According to the exposure draft of the revision of the Drug Administration Law of PRC, the MAH Holder System will be no longer a pilot system but come into force nationwide.
- The purpose of extension of the pilot period of MAH Holder System by the Second Decision is to be integrated with the revision of the Drug Administration Law of the PRC which will hopefully come into effect in the near future.
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