Announcement on Matters Related to the Review and Approval of the Association between……

In order to implement the Opinions of the State Council on Reforming the Drug and Medical Device Evaluation and Approval System (Guofa [2015] No. 44) and simplify the drug approval process, the packaging materials and containers (hereinafter referred to as drug packaging materials) and pharmaceutical excipients that come into direct contact with drugs will be reviewed and approved together with the drug registration application, instead of being approved separately. The relevant matters are hereby announced as follows:

1、 The requirements of this announcement apply to pharmaceutical packaging materials and excipients developed, produced, imported, and used within the territory of the People's Republic of China. The pharmaceutical packaging materials and excipients used in imported drugs shall be implemented in accordance with the relevant provisions of the Drug Registration Management Measures.　　

2、 The State Food and Drug Administration, in accordance with the principle of risk management, conducts associated review and approval of drug packaging materials and pharmaceutical excipients when approving drug registration applications. The State Food and Drug Administration has formulated and announced the scope of drug packaging materials and pharmaceutical excipients for implementation of related review and approval (see Annex 1), and has made adjustments and improvements according to work needs. Pharmaceutical packaging materials and excipients that have not yet been included in the scope of related review and approval should meet the pharmaceutical requirements.

3、 Starting from the date of this announcement, drug packaging materials and pharmaceutical excipients shall be associated with drug registration applications for application and review and approval in accordance with the procedures (see Annex 2). The "Requirements for Application Materials for Drug Packaging Materials and Pharmaceutical Excipients" shall be published separately. Food and drug supervision and management departments at all levels will no longer independently accept registration applications for pharmaceutical packaging materials and excipients, nor will they issue relevant registration approval documents separately.

4、 When there are changes in the prescription, process, quality standards, etc. of pharmaceutical packaging materials and excipients that affect product quality, the production enterprise should take the initiative to conduct corresponding evaluations, timely notify the pharmaceutical production enterprise, and submit relevant information to the food and drug supervision and management department as required. The relevant requirements for changes in pharmaceutical packaging materials and excipients shall be separately formulated by the State Food and Drug Administration.

5、 The approved pharmaceutical packaging materials and excipients shall continue to be valid within their validity period. After the expiration of the validity period, it can continue to be used in the original drug. When used in clinical trials or production applications for other drugs, relevant information should be submitted in accordance with the requirements of this announcement.

Pharmaceutical packaging materials and excipients whose approval documents expire before December 31, 2017 (inclusive) shall be valid until December 31, 2017. Starting from January 1, 2018, when applying for clinical trials or production of drugs used for other drugs, relevant information should be submitted in accordance with the requirements of this announcement.

Other medicinal excipients that meet the medicinal requirements that have been historically used in marketed drugs can continue to be used in the original drug. When applying for clinical trials or production of drugs used for other drugs, relevant information should be submitted in accordance with the requirements of this announcement.

6、 Pharmaceutical packaging materials and pharmaceutical excipients production enterprises should be responsible for product quality; Production should be organized under the conditions of meeting the corresponding production quality management requirements; We should cooperate with pharmaceutical production enterprises to conduct supplier audits.

7、 The applicant for drug registration should ensure that the drug packaging materials and excipients used meet the medicinal requirements; We should strengthen the audit of suppliers of pharmaceutical packaging materials and excipients; It is necessary to timely grasp the changes in pharmaceutical packaging materials and excipients, and study and evaluate the impact of the changes. Corresponding supplementary applications should be submitted to the food and drug supervision and management department in accordance with relevant regulations such as the Drug Registration Management Measures.

8、 The food and drug supervision and management department in the location of pharmaceutical packaging materials and pharmaceutical excipient production enterprises shall include pharmaceutical packaging materials and pharmaceutical excipient production enterprises within the administrative area into the daily supervision scope. The State Food and Drug Administration shall supervise and inspect the production enterprises of imported pharmaceutical packaging materials and pharmaceutical excipients as needed.

9、 This announcement shall come into effect from the date of its publication. Previously accepted registration applications for drugs, drug packaging materials, and pharmaceutical excipients will continue to be reviewed and approved according to the original regulations. If the review and approval requirements for drugs, drug packaging materials, and pharmaceutical excipients are inconsistent with this announcement, this announcement shall prevail.

　This announcement is hereby made.

The State Administration for Food and Drug Administration　　　　　　　　　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　     　                               August 9, 2016