China Supplementary Notice on Further Strengthening Electronic Supervision of Essential Drugs
Title: 101228_China Supplementary Notice on Further Strengthening Electronic Supervision of Essential Drugs
Date Posted: 12/28/110
Tags: REGULATORY UPDATE, REST OF WORLD, CHINA
Comprehensive planning for electronic supervision of all varieties of essential drugs has been made according to the Notice on Electronic Supervision of all Varieties of Essential Drugs (SFDA [2010] 194) and Notice on Implementation of Electronic Supervision of all Varieties of Essential Drugs (SFDA [2010] 237). SFDA issued another Supplementary Notice: Strengthening Electronic Supervision of Essential Drugs on December 22, for further promoting the electronic supervision of all variety of essential drugs: Notice on Electronic Supervision of all Varieties of Essential Drugs (SFDA [2010] 194) and Notice on Implementation of Electronic Supervision of all Varieties of Essential Drugs (SFDA [2010] 237) making comprehensive deployment on the electronic supervision of all varieties of essential drugs. In order to promote its in-depth implementation, solve problems existing through the implementation, a supplementary circular on the relevant matters is hereby given as follows:
I. ENHANCING ELECTRONIC SUPERVISION OF IMPORTED BID-WINNING ESSENTIAL DRUGS
All imported varieties of bid-winning essential drugs should be entered into the network and coded according to the requirements of documents of SFDA [2010] 194 and 237. For varieties that are sub-packaged in China the subpackaging manufacturers must print/paste the drug electronic supervision code with a unified logo in the smallest sales package before March 31, 2011.
Those drugs that are sub-packaged in the original producing areas, relevant enterprises shall print/paste the drug electronic supervision code with a unified logo in the larger package before March 31, 2011 and print/paste the same on the smallest one before December 31, 2011.These companies affected by these new regulations should complete the task of network entry, coding, registration and write-off after verification.
Training of the imported manufacturers will be organized by SFDA. The annual service fee for 2010 digital certificate (Key Fee is 300 RMB/key/manufacturer) of manufacturers will be paid by the administration of the province (autonomous region or municipality) where the enterprise is located. If any digital certificates are needed expenses shall be the onus and be borne by the manufacturer. Other related expenses incurred shall also be borne by the enterprises concerned.
II. STANDARDIZING MANAGEMENT OF PRINTING/PASTING ELECTRONIC SUPERVISION CODES ON SOME MINIMUM PACKAGES
According to the requirements of the annex ("Printing Standard of Drug Supervision Code, Supplementary Notice on Related Problems Arising from Implementation of Electronic Supervision of Drugs (SFDA [2008]153)") states: If the size of the minimum package is too small or the bottles are specially shaped and under other special circumstances where drug electronic supervision codes with unified logo cannot be printed/pasted the code may be printed on the larger package of the minimum one. If there are any such variances the manufacturers should apply to the provincial food and drug administration for its examination and approval. Thereafter they should be confirmed in the system applicable.
If the imported varieties of bid-winning essential drugs that are packaged in the original producing areas belong to circumstances prescribed in the preceding paragraph, their offices or authorized agents in China shall apply to the provincial food and drug administration for its examination and approval. Thereafter they should be confirmed in the system applicable.
III. GUIDING DRUG ELECTRONIC SUPERVISION AND MANUFACTURERS ON SYSTEM INTEGRATION TRANSFORMATION
System integration of manufacturers plays an important role in the smooth completion of varieties of electronic supervision. The provincial administrations should guide the enterprises in their jurisdiction to design their technical transformation programs according to their actual situations, scales, financial capacity and enterprise resource planning (ERP) system status, choose suitable and reliable system integrators, urge drug manufacturers to transform production lines and jointly debug and test with SFDA system platform so that electronic supervision of all varieties of essential drugs will be completed on schedule.
IV. STRENGTHENING ELECTRONIC SUPERVISION OF THE VARIETIES OF ESSENTIAL DRUGS ADDED BY THE PROVINCES
The network entry of the varieties of essential drugs added by the provinces shall be managed by the corresponding provincial administrations. The enterprises should apply to the China Pharmaceutical Electronic Supervision Network for drug electronic supervision codes.
Unsuccessful tenders of essential drug manufacturers are encouraged to join China Pharmaceutical Electronic Supervision Network voluntarily. The unsuccessful tenders of essential drug manufacturers that join China Pharmaceutical Electronic Supervision Network voluntarily will be managed by their corresponding provincial administrations. These enterprises should apply to China Pharmaceutical Electronic Supervision Network for drug electronic supervision codes.
Varieties that have joined in China Pharmaceutical Electronic Supervision Network should be registered and written-off after verification by operation and wholesale enterprises to ensure the normal operation of the network and the integrity and reliability of the data.
V. FURTHER INCREASING THE INTENSITY OF TRAINING AND TECHNICAL GUIDANCE
Information management departments of provincial administration should effectively conduct training of drug electronic supervision on the production and wholesale companies and staff of drug regulatory agencies in their jurisdiction, make good use of technical advantages, coordinate and conduct technical services of electronic supervision in their jurisdiction.