Releasedon 10th 08, 2016

To implement the" Suggestions of the State Council on the reform of drug and medicinal device review and approval system" (GuoFa 2015 No. 44),to simplify the drug approval process, packaging materials and containerscontact with drugs (hereinafter referred to as packaging materials), medicinalexcipients will be reviewed and approved together with drug in the registrationapplication. The announcements are made as follows:

1.      Themedicinal excipients developed, produced, imported and used in the territory ofPeople's Republic of China shall be applied to the requirements of this announcement. The pharmaceutical packagingmaterials and medicinal excipients used in the imported drugs are carried outin accordance with the relevant provisions of "Drug RegistrationRegulations ".

2.      TheState Administration of food and drug administration review and approve pharmaceuticalpackaging materials and medicinal excipients together with drug in theregistration application in accordance with the principle of risk management.The State Food and drug administration has formulated and announced the scopeof the package materials and pharmaceutical excipients for joint evaluation(see attachment 1), adjusted and perfected according to the needs of work. The pharmaceuticalpackaging materials and medicinal excipients which are not included in the scopeshall be in accordance with the medicinal requirements.

3.      Fromthe date of the announcement, the pharmaceutical packaging materials andpharmaceutical excipients should be reported and reviewed in accordance withthe procedures (see Annex 2) and the application for drug registration. “Therequirements for the declaration materials for pharmaceutical packagingmaterials and medicinal excipients” will be announced separately. The departments offood and drug supervision and administration will no longer accept theapplication for registration of pharmaceutical packaging materials and medicinalexcipients separately, and no longer issue relevant registration approvaldocuments separately.

4.      Whenthere is any change in the formulation, process and quality standard which mayaffect the quality of products, the manufacturers should carry out thecorresponding evaluation, inform the pharmaceutical manufacturers timely, andsubmit relevant information to the food and drug administration according tothe requirements. The relevant requirements for the change of pharmaceuticalpackaging materials and medicinal excipients shall be formulated separately bythe State Administration of food and drug administration.

5.      Forthe pharmaceutical packaging materials and medicinal excipients which have beenapproved, their approval documents will continue to be effective within theperiod of effect. After the expiration of the validity period, it can continueto be used in the original medicine. If used in other drug clinical trials orproduction applications, the relevant information shall be submitted inaccordance with the requirements of this announcement.

Thepharmaceutical packaging materials and medicinal excipients which will expirebefore December 31, 2017 (including the same day) are valid until December 31,2017. Since January 1, 2018, if used in other drug clinical trials orproduction applications, the relevant information shall be submitted inaccordance with the requirements of this announcement.

Othermedicinal excipients, which have been used in the history of the listed drugs,can continue to be used in the original medicine. However, if used in otherdrug clinical trials or production applications, the relevant information shallbe submitted in accordance with the requirements of this announcement.

6.      Manufacturersof pharmaceutical packaging materials and medicinal excipients should beresponsible for the quality of products. They should organize production underthe requirements of corresponding production quality management, and cooperatewith pharmaceutical manufacturers to carry out supplier audit.

7.      Drugregistration applicant shall ensure the pharmaceutical packaging materials and medicinalexcipients used shall meet the requirements for medicinal use, shall strengthensupplier audit for pharmaceutical packaging materials and medicinal excipients,shall promptly grasp the change of pharmaceutical packaging materials and medicinalexcipients, research and assess the impact of the changes, submit thecorresponding supplementary application to the food and drug supervision andmanagement departments in accordance with the relevant provisions of the "Drug RegistrationRegulations ".

8.      Foodand drug supervision and administration departments at the locality ofpharmaceutical packaging materials and medicinal excipients shall include thepharmaceutical packaging materials and medicinal excipients manufacturers inthe administrative area in the daily regulatory scope. The State Administrationof food and drug supervision and administration shall supervise and inspect theimported pharmaceutical packaging materials and medicinal excipientsmanufacturers according to the needs.

9.      Thisannouncement comes into force on the date of promulgation. The registeredapplications for drugs, pharmaceutical packaging materials and medicinalexcipients have been reviewed and approved according to the originalregulations. If the requirements for examination and approval of drugs,pharmaceutical packaging materials and medicinal excipients are not consistentwith the present proclamation, this announcement shall prevail.

Annexes: 

1.The scope of pharmaceuticalpackaging materials and medicinalexcipients for joint evaluation (Trial)

2.Procedure for joint evaluation and approval forpharmaceutical package materials, medicinal excipients and drugs (Trial)

 General Administration of Food and DrugAdministration

2016.08.09