In order to implement the "Opinions of the State Council on the Approval System for Reforming the Reform of the Medical Device Review and Approval" (Guo Fa [2015] No. 44)，Simplified drug approval procedures，The packaging materials and containers of the drug will be directly exposed to the drug (hereinafter referred to as the pharmaceutical packaging material)、The medicinal auxiliary materials are changed from individual approval to review and approval when applying for drug registration。The relevant matters are announced as follows:

 

  1、Develop in the territory of the People's Republic of China、Production、Pharmaceutical bags imported and used、Medicinal Accessories，stake online sports bettingApplicable this announcement requirements。Pharmaceutical bag materials used in imported drugs、Pharmaceutical anuxiliary materials shall be implemented in accordance with the relevant provisions of the "Administrative Measures for Drug Registration"。

 

  2、The State Food and Drug Administration in accordance with the principles of risk management, when applying for drug registration application、Pharmaceutical Accessiments Implementation Approval and Approval。The State Administration of Food and Drug Administration formulated and announced the implementation of the pharmaceutical bag material for the implementation of related review and approval、Pharmaceutical Accessories range (see Annex 1)，and adjust and improve according to the needs of the work。Pharmaceutical bag materials that are not yet included in the scope of related review and approval、Medicinal accessories should meet the medicinal requirements。

 

  3、From the date of the announcement of this announcement，Pharmaceutical bag、The medicinal auxiliary materials shall be approved and approved for the application for application and review of the drug registration application (see Annex 2)，"Requirements for the Requirement of Pharmaceutical Pharmaceuticals and Medicinal Accessories Declaration Information" will be announced separately。Food and drug supervision and management departments at all levels will no longer accept pharmaceutical packaging materials、Registration application for medicinal auxiliary materials，No longer issuing relevant registration approval certification documents。

 

  stake online sports betting4、Pharmaceutical bag、Change of the medicinal auxiliary materials to change the prescription、Craft、Quality Standard and other changes that affect the quality of the product，Its production enterprises should actively carry out corresponding evaluations，Timely notify drug production enterprises，and submit relevant information to the food and drug supervision and management department as required。Pharmaceutical bag、The relevant requirements of the change of medicinal auxiliary materials will be formulated separately by the State Food and Drug Administration。

 

  5、Approved Pharmaceutical Bag Material、Medicinal Accessories，Its approval certification documents continue to be valid during the validity period。After the expiry of the validity period，can continue to be used in the original medicine。When clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。

 

  Approve the certificate of the certification documents that expires before December 31, 2017 (including the day)、Medicinal Accessories，The validity period continues to December 31, 2017。From January 1, 2018，Drug clinical trials or production applications for other drugs，The relevant information should be submitted according to the requirements of this announcement。

 

  Other pharmaceutical accessories used in the history of drugs in the marketing drugs，can continue to be used in the original medicine。But when applying or production application for drug clinical trials for other drugs，The relevant information should be submitted according to the requirements of this announcement。

 

  6、Pharmaceutical bag、Pharmaceutical auxiliary materials manufacturers should be responsible for product quality; production should be organized under the conditions of meeting stake sports betting appcorresponding production quality management requirements;。

 

  7、Drug registration applicants should ensure that the medicine bag used、Medicinal accessories meet the medicinal requirements; pharmaceutical packaging materials should be strengthened、Audit of the supplier of medicinal auxiliary materials; should be grasped in time、Change of medicinal auxiliary materials，and research and evaluate the impact caused by the change，In accordance with the relevant provisions of the "Administrative Measures for Drug Registration", submit a corresponding supplementary application to the food and drug supervision and management department。

 

  eight、Pharmaceutical bag、The food and drug supervision and management department where the pharmaceutical auxiliary materials manufacturer is located shall bring the drug bag material in the administrative area、Pharmaceutical auxiliary materials manufacturers are included in the scope of daily supervision。The State Food and Drug Administration of Food and Drug Administration is on imported drug bags as required、Medicinal accessories manufacturers conduct supervision and inspection。

 

  Nine、This announcement is implemented from the date of release。Drugs that have been accepted before、Registration application for pharmaceutical packaging materials and medicinal accessories continues to review and approve in accordance with the original regulations，Previous medicine、Pharmaceutical packaging materials and medicinal auxiliary materials review and approval requirements are not consistent with this announcement，Taking this announcement as the subject。

 

  Feeling announcement.