Sfda: On The Protection Of Pharmaceutical Regulatory Network Operation And Management Issues Of

585 Provinces, autonomous regions and municipalities directly under Food and Drug Administration (Drug Administration):

For the realization of the second class of psychotropic drugs, and some high-risk drug production factory, the dynamic flow control to ensure that the real drugs, can be traced back, the State Food and Drug Administration (hereinafter referred to as the State Agency) drugs in special electronic monitoring network Based on the initial completion of the National Drug electronic control network information system (hereinafter referred to as electronic monitoring network). In accordance with the "electronic monitoring on the implementation of Drug Issues related to the work" (State Food and Drug Administration's Office 2008 No. 165) requires, for the protection of electronic monitoring network for the normal operation, clear the drug regulatory departments at all levels, drug manufacturers, pharmaceutical trading enterprises responsibilities, relevant matters are announced as follows:

1, the basic principles of operation of electronic monitoring network

State Board in accordance with the comprehensive plan, step by step, step by step principle, classified in groups to implement electronic monitoring of drug.

All production and management of electronic monitoring network directory to include varieties of pharmaceutical companies, drugs should be in accordance with the relevant provisions of the regulatory network of networks of electronic procedures.

Pharmaceutical enterprises in accordance with the electronic monitoring code printing specifications, in the drug outside the label affixed to print or electronic monitoring code.

Second, the drug regulatory agency responsibilities

(A) of the drug regulatory authorities at all levels of electronic monitoring network should be regulated as drugs of electronic platforms, designate a person responsible for monitoring network of electronic business processes and basic information on maintenance work, and organize appropriate training and guidance to carry out the necessary work.

(B) of the National Council for the electronic monitoring of drugs on the information network maintenance and updates, inspect and supervise the drug regulatory departments of the provincial area network of electronic monitoring and day to day supervision and management of early warning information processing, and made significant early warning event treatment guidance.

(C) the drug regulatory departments of provincial jurisdiction pharmaceutical production enterprises to maintain and update basic information, inspect and supervise lower-level Drug Administration warning on the area of information processing, a significant written report of the national early warning events Bureau.

(D) of the provincial drug supervision and administration department of medicine production and business enterprises are not in accordance with the norms and procedures related to the use of electronic monitoring network report the relevant information, resulting in the relevant business data anomalies, shall order the enterprise rectification, where necessary, conduct on-site inspection urge the rectification.

Third, the drug regulatory departments at all levels should supervise the area in pharmaceutical production, enterprises do related work

(1) pharmaceutical companies should be based on the production of drug products, specifications and actual production application of the code.

(B) of the drug manufacturer code printed on the monitor, affixed to such electronic monitoring network should be strictly "manual" of the relevant technical requirements.

(C) pharmaceutical companies should designate a person responsible for the production of drugs to maintain and update information on electronic monitoring, verification of nuclear injection, and to ensure that submitted information in a timely manner, complete and accurate.

(D) shall not be counterfeit medicine production enterprises, misused or repeated use of regulatory codes, regulatory codes, and any surplus should be destroyed in time off the record; if lost or disclosure shall promptly report in writing the local Drug Administration, also copy to the State Council.

(5) drug manufacturers should designate a person responsible for the pharmaceuticals business of electronic monitoring maintenance and updating of information, verification of nuclear injection, and to ensure that submitted information in a timely manner, complete and accurate.

by: heiyou

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