Announcement of the State Administration of pharmaceutical packaging materials on the related review and approval of pharmaceutical excipients and drugs (2016 No. 134)

Source: CFDA 2016-8-11 to implement the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] 44) No.), simplify the drug approval process, and change the packaging materials, containers (hereinafter referred to as drug packaging materials) and pharmaceutical auxiliary materials that are directly in contact with drugs from independent approval to review and approval together with the drug registration application The relevant matters are hereby announced as follows: 1 The requirements of this announcement are applicable to the drug packaging materials and pharmaceutical auxiliary materials developed, produced, imported and used within the territory of the people's Republic of China The pharmaceutical packaging materials and pharmaceutical auxiliary materials used in imported drugs 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, conduct the associated review and approval of drug packaging materials and pharmaceutical excipients when approving drug registration applications The State Food and Drug Administration formulates and publishes the scope of drug packaging materials and pharmaceutical excipients subject to related review and approval (see Annex 1), and makes adjustments and improvements according to the work needs The drug packaging materials and auxiliary materials not included in the scope of related review and approval shall meet the requirements for medicine 3、 From the date of this announcement, drug packaging materials and pharmaceutical excipients shall be declared and reviewed and approved in accordance with the procedures (see Annex 2) and drug registration application, and the application data requirements for drug packaging materials and pharmaceutical excipients shall be published separately The food and drug administration at all levels will no longer independently accept the application for registration of drug packaging materials and pharmaceutical auxiliary materials, and will no longer independently issue the relevant registration approval documents 4、 In case of change of prescription, process, quality standard and other changes affecting product quality of drug packaging materials and pharmaceutical auxiliary materials, the manufacturer shall take the initiative to carry out corresponding assessment, timely notify the drug manufacturer, and submit relevant materials to the food and drug administration as required The relevant requirements for the change of drug packaging materials and pharmaceutical excipients shall be formulated separately by the State Food and drug administration 5、 For the approved drug packaging materials and pharmaceutical auxiliary materials, the approval documents shall continue to be valid within the validity period After the expiration of the validity period, it can continue to be used in the original drugs If it is used in clinical trials or production applications of other drugs, relevant materials shall be submitted according to the requirements of this announcement For drug packaging materials and pharmaceutical excipients whose approval documents expire before December 31, 2017 (inclusive), the validity period shall continue to December 31, 2017 From January 1, 2018, when applying for clinical trials or production of other drugs, relevant materials shall be submitted according to the requirements of this announcement Other pharmaceutical excipients that meet the pharmaceutical requirements and have been used in the listed drugs for a long time may continue to be used in the original drugs However, when applying for clinical trials or production of drugs for other drugs, relevant materials shall be submitted in accordance with the requirements of this announcement 6、 Pharmaceutical packaging materials and pharmaceutical auxiliary materials manufacturing enterprises shall be responsible for product quality; organize production under the conditions of meeting the corresponding production quality management requirements; cooperate with pharmaceutical manufacturing enterprises to carry out supplier audit 7、 The applicant for drug registration shall ensure that the used drug packaging materials and auxiliary materials meet the requirements for drug use; strengthen the audit of the suppliers of drug packaging materials and auxiliary materials; timely grasp the change of drug packaging materials and auxiliary materials, study and evaluate the impact of the change, and submit the corresponding information to the food and Drug Administration in accordance with the measures for the administration of drug registration and other relevant provisions Supplementary application 8、 The food and drug supervision and administration department in the place where the drug packaging material and pharmaceutical auxiliary material production enterprises are located shall include the drug packaging material and pharmaceutical auxiliary material production enterprises in the administrative region into the scope of daily supervision The State Food and drug administration shall supervise and inspect the production enterprises of imported drug packaging materials and pharmaceutical auxiliary materials as required 9、 This announcement shall come into force as of the date of promulgation The previously accepted applications for registration of drugs, drug packaging materials and pharmaceutical excipients shall continue to be reviewed and approved in accordance with the original provisions If the review and approval requirements for drugs, drug packaging materials and pharmaceutical excipients are inconsistent with this announcement, this announcement shall prevail It is hereby announced Annex: 1 Scope of drug packaging materials and pharmaceutical excipients subject to associated review and approval (Trial) 2 Review and approval procedures of drug packaging materials, pharmaceutical excipients and drugs (Trial) CFDA Announcement No 134, 2016, August 9, 2016, Annex 1 Docx Announcement No 134, 2016, annex 2 Docx