Circular of the General Office of the State Council on Issuing the Pilot Program for the Drug Marketing Authorization Holder System
Circular of the General Office of the State Council on Issuing the Pilot Program for the Drug Marketing Authorization Holder System
Circular of the General Office of the State Council on Issuing the Pilot Program for the Drug Marketing Authorization Holder System
Guo Ban Fa [2016] No.41
May 26, 2016
People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, and ministries and commissions of and departments directly under the State Council,
The Pilot Program for the Drug Marketing Authorization Holder System, which has been approved by the State Council, is hereby issued.
Implementing the pilot program for the drug marketing authorization holder system is an important content of the drug review and approval system reform, and is of great importance to encouraging drug innovation and improving drug quality. All the relevant regions shall pay high attention and carefully organize the implementation in line with the requirements of the pilot program. The China Food and Drug Administration ("CFDA") shall, in concert with the relevant departments, improve supporting policies, strengthen the organization and guidance as well as supervision and inspection, promote the pilot program in a steady and orderly manner, ensure the quality and safety of the drugs under the pilot program and timely report any major circumstances and issues to the State Council.
Pilot Program for the Drug Marketing Authorization Holder System
According to 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 Places and the Relevant Issues, the pilot drug marketing authorization holder system shall be implemented in ten provinces and municipalities directly under the Central Government, namely, Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan. The following program is hereby formulated in order to effectively carry out the pilot work.
I. Content of This Program
Drug research institutes or researchers in the pilot administrative regions may serve as the applicants for the drug registration (the "applicants") and file applications for clinical drug trails and drug marketing; and any applicant granted the drug marketing permit and a drug approval number may become a drug marketing authorization holder (the "holder"). The applicants and the holders shall correspondingly assume the relevant legal liability for clinical drug trails and drug manufacturing and marketing specified in the laws and regulations.
If a holder has no corresponding manufacturing qualification, the holder shall entrust a qualified drug manufacturer (the "commissioned manufacturer") in the pilot administrative region concerned to manufacture the drugs approved for marketing. If a holder has the corresponding manufacturing qualification, the drugs may be manufactured by the holder itself or by a commissioned manufacturer.
During the examination and approval of an application for drug registration or after the application is approved, the application or the holder concerned may file a supplementary application for changing the applicant, the holder or the commissioned manufacturer.
II. Scope of Drugs under This Program
1. New drugs approved for marketing after the implementation of this Program, including: (1) chemical drugs of categories 1 to 4 and category 5 (limited to targeted preparation, sustained-release preparation and controlled release preparation), traditional Chinese medicine and natural drugs of categories 1 to 6, biological products for therapy of categories 1 and 7 and bio-similar drugs, registered, classified and declared in accordance with the existing Administrative Measures for Drug Registration; and (2) chemical drugs of categories 1 and 2 declared in accordance with the new registration categories of chemical drugs (the "new registration categories") after the reform of the registration classification of chemical drugs is carried out.
2.
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Guo Ban Fa [2016] No.41
May 26, 2016
People's governments of all provinces, autonomous regions and municipalities directly under the Central Government, and ministries and commissions of and departments directly under the State Council,
The Pilot Program for the Drug Marketing Authorization Holder System, which has been approved by the State Council, is hereby issued.
Implementing the pilot program for the drug marketing authorization holder system is an important content of the drug review and approval system reform, and is of great importance to encouraging drug innovation and improving drug quality. All the relevant regions shall pay high attention and carefully organize the implementation in line with the requirements of the pilot program. The China Food and Drug Administration ("CFDA") shall, in concert with the relevant departments, improve supporting policies, strengthen the organization and guidance as well as supervision and inspection, promote the pilot program in a steady and orderly manner, ensure the quality and safety of the drugs under the pilot program and timely report any major circumstances and issues to the State Council.
Pilot Program for the Drug Marketing Authorization Holder System
According to 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 Places and the Relevant Issues, the pilot drug marketing authorization holder system shall be implemented in ten provinces and municipalities directly under the Central Government, namely, Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan. The following program is hereby formulated in order to effectively carry out the pilot work.
I. Content of This Program
Drug research institutes or researchers in the pilot administrative regions may serve as the applicants for the drug registration (the "applicants") and file applications for clinical drug trails and drug marketing; and any applicant granted the drug marketing permit and a drug approval number may become a drug marketing authorization holder (the "holder"). The applicants and the holders shall correspondingly assume the relevant legal liability for clinical drug trails and drug manufacturing and marketing specified in the laws and regulations.
If a holder has no corresponding manufacturing qualification, the holder shall entrust a qualified drug manufacturer (the "commissioned manufacturer") in the pilot administrative region concerned to manufacture the drugs approved for marketing. If a holder has the corresponding manufacturing qualification, the drugs may be manufactured by the holder itself or by a commissioned manufacturer.
During the examination and approval of an application for drug registration or after the application is approved, the application or the holder concerned may file a supplementary application for changing the applicant, the holder or the commissioned manufacturer.
II. Scope of Drugs under This Program
1. New drugs approved for marketing after the implementation of this Program, including: (1) chemical drugs of categories 1 to 4 and category 5 (limited to targeted preparation, sustained-release preparation and controlled release preparation), traditional Chinese medicine and natural drugs of categories 1 to 6, biological products for therapy of categories 1 and 7 and bio-similar drugs, registered, classified and declared in accordance with the existing Administrative Measures for Drug Registration; and (2) chemical drugs of categories 1 and 2 declared in accordance with the new registration categories of chemical drugs (the "new registration categories") after the reform of the registration classification of chemical drugs is carried out.
2.
......