The NPC Standing Committee’s Decision on Authorizing the State Council to Carry out the Pilot Drug Marketing Authorization Holder System in Some Places and Related Issues

In order to promote the reform of the drug review and approval system, encourage drug innovation, improve drug quality, and provide practical experience for further reform and improvement of the drug management system, the 17th meeting of the Standing Committee of the 12th National People's Congress decided:

1. Authorize the State Council to carry out a pilot program of the drug marketing authorization holder system in ten provinces and municipalities directly under the Central Government, including Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Sichuan, allowing drug research and development institutions and scientific researchers to obtain drug approval numbers and assume corresponding responsibilities for drug quality.

2. Agree that the State Council will organize and carry out drug registration classification reform, improve drug quality, and promote the transformation and upgrading of my country's drug industry. To this end, in accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China, drugs approved for production that have national drug standards shall comply with national drug standards and achieve the quality and efficacy of original research drugs; drugs approved for production that have been marketed overseas but not yet marketed in China, if there are no national drug standards, shall achieve the quality and efficacy of original research drugs. The State Food and Drug Administration shall formulate and revise relevant national drug standards in a timely manner in accordance with the above requirements.

The pilot period authorized by this decision is three years, starting from the date of implementation of this decision. The State Food and Drug Administration shall formulate a specific pilot program and submit it to the Standing Committee of the National People's Congress for filing after approval by the State Council. During the pilot period, the State Council shall strengthen the organization, guidance and supervision and inspection of the pilot work to ensure the quality and safety of drugs. After the pilot period expires, the "Drug Administration Law of the People's Republic of China" shall be amended and improved for those proven feasible in practice; for those proven in practice not suitable for adjustment, the provisions of the "Drug Administration Law of the People's Republic of China" shall be restored. The drug approval number obtained during the pilot period shall continue to be valid after the pilot period expires. Before the expiration of the pilot period, the State Council shall submit a report on the implementation of this decision to the Standing Committee of the National People's Congress.

This decision shall take effect on November 5, 2015.

Specific news link: Decision of the Standing Committee of the National People's Congress on authorizing the State Council to carry out pilot projects on the drug marketing authorization holder system in some places and related issues