Circular of the China Food and Drug Administration on Seeking Public Comments on the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment)
Circular of the China Food and Drug Administration on Seeking Public Comments on the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment)
Circular of the China Food and Drug Administration on Seeking Public Comments on the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment)
March 21, 2018
In order to promote the transformation of the research and development achievements of new drugs and the rational flow of production technologies, encourage the merger and restructuring of drug marketing authorization holders and drug manufacturers, and regulate the registration of changes to drug production sites, the China Food and Drug Administration has, in accordance with the Drug Administration Law of the People's Republic of China, the Implementing Regulations of the Drug Administration Law of the People's Republic of China and other applicable laws and regulations, formulated the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment), which are hereby published for public consultation. The general public may visit the official website of the Legislative Affairs Office of the State Council (address: http://www.chinalaw.gov.cn) to give opinions through the Column "Comments Sought on the Legislation" under the main menu on the first page by April 19, 2018.
Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment)
Article 1 (Legal basis) In order to promote the transformation of the research and development achievements of new drugs and the rational flow of production technologies, encourage the merger and restructuring of drug marketing authorization holders and drug manufacturers, and regulate the registration of changes to drug production sites, the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (the "Provisions") are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementing Regulations of the Drug Administration Law of the People's Republic of China.
Article 2 (Scope of application) The Provisions apply to the evaluation, examination and approval of the application for the registration of changes to the drug production sites for traditional Chinese medicines, chemical drugs and biological products and preparations already launched on the market.
For changes to the drug production sites of active pharmaceutical ingredients already launched on the market, registration of changes in relevant information shall be handled through the registration platform for active pharmaceutical ingredients, pharmaceutical excipients and pharmaceutical packaging materials in accordance with the relevant provisions.
Article 3 (Definition of changes) For the purpose of the Provisions, the term "changes to drug production sites" refers to changes to the actual production plants (including manufacturing, packaging, inspection and release) and production lines of drugs, including changes to the production addresses or to the production facilities at the same production address.
The same production address means that the old and new plants used for actual production have the same physical address.
......
March 21, 2018
In order to promote the transformation of the research and development achievements of new drugs and the rational flow of production technologies, encourage the merger and restructuring of drug marketing authorization holders and drug manufacturers, and regulate the registration of changes to drug production sites, the China Food and Drug Administration has, in accordance with the Drug Administration Law of the People's Republic of China, the Implementing Regulations of the Drug Administration Law of the People's Republic of China and other applicable laws and regulations, formulated the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment), which are hereby published for public consultation. The general public may visit the official website of the Legislative Affairs Office of the State Council (address: http://www.chinalaw.gov.cn) to give opinions through the Column "Comments Sought on the Legislation" under the main menu on the first page by April 19, 2018.
Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (Draft for Comment)
Article 1 (Legal basis) In order to promote the transformation of the research and development achievements of new drugs and the rational flow of production technologies, encourage the merger and restructuring of drug marketing authorization holders and drug manufacturers, and regulate the registration of changes to drug production sites, the Administrative Provisions on the Examination and Approval of the Registration of Changes to Drug Production Sites (the "Provisions") are formulated in accordance with the Drug Administration Law of the People's Republic of China and the Implementing Regulations of the Drug Administration Law of the People's Republic of China.
Article 2 (Scope of application) The Provisions apply to the evaluation, examination and approval of the application for the registration of changes to the drug production sites for traditional Chinese medicines, chemical drugs and biological products and preparations already launched on the market.
For changes to the drug production sites of active pharmaceutical ingredients already launched on the market, registration of changes in relevant information shall be handled through the registration platform for active pharmaceutical ingredients, pharmaceutical excipients and pharmaceutical packaging materials in accordance with the relevant provisions.
Article 3 (Definition of changes) For the purpose of the Provisions, the term "changes to drug production sites" refers to changes to the actual production plants (including manufacturing, packaging, inspection and release) and production lines of drugs, including changes to the production addresses or to the production facilities at the same production address.
The same production address means that the old and new plants used for actual production have the same physical address.
......