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In order to implement the Opinions of the State Council […]
In order to implement the Opinions of the State Council on Reforming the System for the Review and Approval of Drugs and Medical Devices (Guo Fa [2015] No. 44), to simplify the procedures for drug approval, direct contact will be made with packaging materials and containers for drugs (hereinafter referred to as drug packaging materials), drugs The use of excipients has been changed from independent examination to review and approval together when examining drug registration applications. The relevant matters are announced as follows:
(1) The requirements of this announcement shall apply to pharmaceutical packaging materials and pharmaceutical excipients developed, produced, imported and used in the territory of the People's Republic of China. Pharmaceutical packaging materials and medicinal auxiliary materials used in imported medicines shall be implemented in accordance with the relevant provisions of the Measures for the Administration of Drug Registration.
2. The State Food and Drug Administration shall, in accordance with the principle of risk management, carry out related review and approval of pharmaceutical packaging materials and pharmaceutical excipients when approving drug registration applications. The State Food and Drug Administration has formulated and announced the scope of pharmaceutical packaging materials and pharmaceutical excipients that are subject to related review and approval (see Annex 1), and adjusted and improved according to the needs of the work. Pharmaceutical packaging materials and medicinal excipients that have not been included in the scope of related review and approval shall meet the requirements for medicinal use.
3. As of the date of this announcement, pharmaceutical packaging materials and medicinal excipients shall be reported and reviewed in accordance with the procedures (see Annex 2) and associated with drug registration applications. The "Requirements for the Declaration of Pharmaceutical Packaging Materials and Medicinal Excipients" will be announced separately. . Food and drug supervision and administration departments at all levels will no longer accept applications for registration of pharmaceutical packaging materials and pharmaceutical excipients separately, and will no longer issue separate registration approval certification documents.
4. When pharmaceutical packaging materials, pharmaceutical excipients change prescriptions, processes, quality standards and other changes that affect product quality, their production enterprises should take the initiative to carry out corresponding evaluations, promptly notify drug production enterprises, and submit to the Food and Drug Administration as required. Submit relevant information. Relevant requirements for the change of pharmaceutical packaging materials and pharmaceutical excipients shall be separately formulated by the State Food and Drug Administration.
V. Approval documents for approved pharmaceutical packaging materials and pharmaceutical excipients will continue to be valid during the validity period. After the expiry of the validity period, it can continue to be used in the original medicine. If it is used for clinical trials or production applications of other drugs, relevant information shall be submitted in accordance with the requirements of this announcement.
Medicinal packaging materials and medicinal excipients whose approval documents have expired before December 31, 2017 (including the date), the validity period is extended to December 31, 2017. Since January 1, 2018, when clinical trials or production applications for other drugs are used, relevant information should be submitted in accordance with the requirements of this announcement.
其他 Other medical excipients that have been used in the market in the past and meet the requirements of medicinal products can continue to be used in the original drugs. However, when applying for clinical trials or manufacturing applications for other drugs, relevant information shall be submitted in accordance with the requirements of this announcement.
26. Manufacturers of pharmaceutical packaging materials and pharmaceutical excipients shall be responsible for the quality of their products; they shall organize production under conditions that meet the requirements of corresponding production quality management; they shall cooperate with pharmaceutical manufacturers to conduct supplier audits.
7. Applicants for drug registration shall ensure that the used pharmaceutical packaging materials and pharmaceutical excipients meet the requirements for pharmaceutical use; they shall strengthen the audit of suppliers of pharmaceutical packaging materials and pharmaceutical excipients; and shall promptly grasp the changes of the pharmaceutical packaging materials and pharmaceutical excipients, and Study and evaluate the impact of the changes, and submit corresponding supplementary applications to the Food and Drug Administration in accordance with relevant regulations such as the “Administrative Measures for Drug Registration”.
VIII. The food and drug supervision and administration department where the pharmaceutical packaging materials and pharmaceutical excipients are located shall include the pharmaceutical packaging materials and pharmaceutical excipients manufacturing enterprises within the administrative area into the daily supervision scope. The State Food and Drug Administration shall supervise and inspect the manufacturers of imported pharmaceutical packaging materials and medicinal auxiliary materials as required.
9. This announcement will be implemented as of the date of publication. The previously accepted applications for registration of medicines, pharmaceutical packaging materials and pharmaceutical excipients will continue to be reviewed and approved in accordance with the original regulations. If the requirements for the review and approval of pharmaceuticals, pharmaceutical packaging materials and pharmaceutical excipients are not consistent with this announcement, this announcement shall prevail.
