Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018

This regulation is formulated in order to strengthen the supervision and administration of internet drug trading, standardize the behavior of internet drug trading and ensure the safety of public drug use. There are six chapters and fifty-seven articles in this regulation, including general principles, administration of internet drug sale, administration of internet drug transaction service platform, supervision and administration, legal liability and supplementary provisions.  

Products Covered: Drugs ICS: 11.120.10. HS: 30

Regulation Type: Regular notification

Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018

Good Data and Record Management Practices (GDRP) include general provisions, quality management, personnel, basic requirements of data, system and supplementary provisions, which is applicable to drug development, manufacture, distribution, post-marketing surveillance and evaluation The data in GDRP should be complete as well as attributable, legible, contemporaneous, original and accurate, commonly referred to as "ALCOA".  

Products Covered: Drugs ICS: 11.120.10  HS: 30

Regulation Type: Regular notification

Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018

Provisions for Overseas Inspection of Drugs and Medical Devices is applicable to the overseas development and production inspection of drugs and medical devices which are already on the market or will be on the market in China. The provisions consist of 5 chapters and 35 articles. 5 Chapters including general provisions, determination of the inspection task, inspection, audit and processing, and supplementary articles. The provisions specify the initiation, inspection and follow-up treatment of overseas drug  and medical device  inspection.

Products Covered: Drug ICS: 11.120.10 HS: 30 Medical device ICS: 11 HS: 9018, 9019, 9020, 9021, 9022

Regulation Type: Regular notification

Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018

This announcement is formulated by reference to international advanced experience, which aims to optimize the review process of drug clinical study, strengthen the communication with applicants, and enhance the review quality and efficiency of drug clinical study. This announcement consists of four parts according to the review process of drug clinical study, including preparation and application of communication meeting, convening of the communication meeting, acceptance, review and approval of drug clinical study application and other related items. In addition, the announcement has three annexes, i.e. application form of communication meeting, requirement for materials of communication meeting and requirement for application of dossier of phase I clinical study.  

Products Covered: Drugs ICS: 11.120.10. HS: 30

Regulation Type: Regular notification

Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018

These measures are formulated to establish a drug quality management system in which marketing authorization holder is the first responsible person, to improve the quality and efficiency of drug registration, and to ensure the safety, effectiveness and quality of drug. Based on management process for review and approval of drug master file (DMF) in support of finished drug product application, these measures consist of seven parts, respectively，General Provisions, Responsibilities and Obligations, DMF Listing, Review and Approval of DMF in Support of Finished Drug Product Application, Alteration and Termination, Supervision and Management, Supplementary Articles.

Products Covered: Drugs ICS: 11.120.10  HS: 30

Regulation Type: Regular notification

Distribution date: 18 January 2018 | Final date for Comment: 17 February 2018

In order to use flesh-bone meal as an ingredient of fertilizers, taking measures to keep livestock away from them, such as adding designated materials, is required so that Transmissible Spongiform Encephalopathy (TSE) should be prevented. Now five materials proved to be effective in keeping livestock away are to be newly designated.

Products Covered: Fertilizer (HS: 3101, 3102, 3104, 3105)

Regulation Type: Regular notification

Distribution date: 18 January 2018 | Final date for Comment: 17 February 2018

Currently ingredients derived from cattle, including gelatin and collagen, can be used for fertilizers provided that those ingredients undergo measures with regard to making prions inert or keeping livestock away from prion sources. Hereafter bovine hide gelatin and collagenare are to be allowed for using as an ingredient of fertilizers without taking these measures. In addition, for using bovine flesh-bone gelatin and collagen as an ingredient of fertilizers, additional measures to reduce infectivity are to be available.

Products Covered: Fertilizer HS: 3101, 3105

Regulation Type: Regular notification

Distribution date: 17 January 2018

Products Covered: 3305.10.00.00

Regulation Type: Addendum to Regular Notification

Distribution date: 16 January 2018

The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives (G/SPS/N/TPKM/426). The final amendment has entered into force on 9 January 2018.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 15 January 2018

Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;

Regulation Type: Addendum to Regular Notification