Food and Drug Administration of each province, autonomous region and municipality directly under the central government (Drug Administration):

  In order to implement the special provisions of the State Council on strengthening the supervision and administration of food and other products safety and the notice of the general office of the State Council on Further Strengthening the supervision and administration of drug safety (GBF [2007] No. 18), accelerate the establishment of key drug safety traceability system, strengthen the supervision of drug quality and safety, and ensure the public drug safety, the State Administration decided to establish a special drug monitoring letter On the basis of information network, further strengthen drug electronic supervision, improve drug labeling system, establish a unified national drug electronic supervision and management network (hereinafter referred to as drug electronic supervision network), and implement electronic supervision over drugs in categories and batches. The following matters are hereby notified as follows:

I. objectives  

  (1) in 2008, electronic supervision over the production and operation of key drugs such as blood products, vaccines, traditional Chinese medicine injections and class II psychotropic drugs will be implemented nationwide.

  (2) from 2009, gradually bring the production and operation of drugs and medical devices approved for registration into electronic supervision.

  II. Working methods and implementation steps

  (1) the State Administration shall formulate and publish the list of drugs on the Internet and the measures for its implementation, and shall, in accordance with the principles of comprehensive planning, step-by-step implementation and gradual promotion, classify and batch the drugs approved for registration into the list of drugs on the Internet and integrate them into the electronic supervision of drugs.

  (2) any enterprise that produces or markets the traditional Chinese medicine in the catalogue of drugs on the Internet must join the electronic supervision network of drugs within the prescribed time. Before the products listed in the catalogue of drugs entering the Internet are put on the market, the electronic supervision code of drugs with unified identification must be added to the minimum sales package of the products (see Annex 1 for the identification of supervision code).

  (3) the first batch of "list of drugs for Internet access" (see Annex 2) are blood products, vaccines, traditional Chinese medicine injections and class II psychotropic drugs。

  (4) when applying for drug registration and obtaining the approval documents for drug registration and production, the enterprises that produce drugs listed in the catalogue of drugs on the Internet must go through the procedures for entering the Internet of drug electronic supervision network at the same time and meet the conditions for assigning the codes of drug electronic supervision code; if they have already obtained the approval documents for drug registration and production, they shall complete the assigning the codes before October 31, 2008.

  (5) for newly established pharmaceutical trading enterprises, if they need to trade the drugs listed in the online drug catalog, they shall go through the procedures for entering the online drug regulatory network and provide the equipment for collecting the electronic drug regulatory code when applying for the pharmaceutical trading license; for those enterprises that have obtained the pharmaceutical trading license, if they need to trade the drugs listed in the online drug catalog, they shall complete the access to the Internet before October 31, 2008 and Relevant facilities shall be equipped, and data shall be submitted through the network at the same time.

  (6) the drugs listed in the catalogue of drugs on the Internet shall not be sold if they are not on the Internet or have not used the unified identification of the electronic supervision code of drugs. Pharmaceutical production and trading enterprises shall not forge or falsely use the electronic supervision code of pharmaceuticals.

  III. work requirements

  (1) all provincial (District, city) bureaus shall fully understand the importance of implementing the drug electronic supervision network to strengthen drug supervision and improve supervision efficiency, and build a unified national drug electronic supervision network in accordance with the requirements of the whole country. The main persons in charge of the provincial (District, city) bureaus shall be in person and specially assigned person shall be responsible for relevant work. To ensure the smooth implementation of the drug electronic regulatory network, we should make clear the responsibilities, make careful arrangements, pay close attention to the implementation, strictly follow the work deployment of the State Administration, and complete the relevant work within the specified time limit.

  (2) in accordance with the unified requirements of the State Administration, we should conscientiously organize the relevant pharmaceutical production and trading enterprises within the jurisdiction, do a good job in the organization and training of relevant personnel, and ensure the effectiveness and quality of the work and training of the drug electronic regulatory network.

  (3) to urge the relevant pharmaceutical production and trading enterprises within their jurisdiction to complete the access, code assignment and code scanning of the drug electronic regulatory network within the prescribed time limit, and to collect and report information in a timely and accurate manner.

  (4) the technical service institutions and operation and maintenance management institutions of the drug electronic regulatory network must ensure the normal operation of the network and the safety and reliability of data and information, and actively carry out the technical service work of various links such as enterprise access to the network, product coding, verification and cancellation of notes, consumption inquiry, regulatory traceability, notification and pre-warning, as well as the technical guidance and training work for the access enterprises Local food and drug regulatory authorities should actively cooperate.

  In the process of implementation, if there is any problem or work suggestion, you can contact the Information Office of the National Bureau in time.

  Contact person: Hai Ying, Hu Yang

  Tel: 010-88331937, 88330332

  Fax: 010-88331937, 68355521

  Email: haiying@sda.gov.cn, huyang@sda.gov.cn