S. S. Y. J. Z. (2011) No. 120

To Food and Drug Administrations concerned,

In light of provisions of Notice on Further Supervision on Drug Re-registration (G. S. Y. J. Z. (2009) No. 387)issued by State Food and Drug Administration, as of September 2010, Jiangsu province has basically accomplished the re-registration of 9,798 drug approval numbers. In order to guarantee the further supervision of drug re-registration, relevant issues are hereby notified as follows:

1. Each municipal Food and Drug Administration shall reinforce the regular supervision of the alteration to drug registration and urge the producers to undertake research and verification in accordance with the requirement of Management Measures of Drug Registration and Principles of Technical Guidance for Chemical Medicine Alteration Research. Supplementary applications shall be reported to provincial administration when needed.

2. In accordance with the requirements of Notice on Further Supervision on Drug Re-registration (G. S. Y. J. Z. (2009) No. 387)issued by State Food and Drug Administration, prescriptions and manufacturing techniques of injections shall be verified and re-registered after meeting the requirements. Whereas the verification on part of prescriptions and techniques has been finished, each municipal Food and Drug Administration shall release the catalogues and get prepared to guarantee the verification prior to June 30. Static verification can be conducted for drugs that are currently off production and the date and causes for the suspension shall be noted. The provincial administration has the qualified drugs conditionally re-registered after verification, namely on-spot inspection and sampling inspection shall be conducted for the reproduced re-registered drugs.

3. Each municipal administration shall urge the drug producers to implement the risk evaluation and relevant technical work on rejections in accordance with the Notice on Releasing the Basic Technical Requirements for Chemical Injections and Multi-Component Bio-chemical Injections (G. S. Y. J. Z. (2008) No. 7) issued by the State Food and Drug Administration. For those small-dose injections qualified for re-registration, administrations shall urge the producers to finish all the research work and deliver the research materials or supplementary application prior to September 30. For those large-dose injections unqualified for germ-free guarantee, re-registration shall be conditionally conducted after the accomplishment of germ-free verification and key item research on quality control. The producer shall finish the rest research work and deliver the research materials or supplementary application prior to September 30. Re-registration shall not be issued to the drugs that are unqualified for germ-free standard and that relevant researches have not been implemented. The producers shall be urged to revoke the drug approval number for the unreasonable dose drugs.

4. The provincial administration has issued re-registration to the drugs in accordance with the re-registration qualification that are off production during the validity of the drug approval number. Each municipal administration shall conduct on-spot inspection and sampling inspection (3 batches for injections and 1 batch for other drugs) when the production is resumed in accordance with the relevant provisions issued by the State Food and Drug Administration, which shall be allowed to be sold in the market through the inspection by the local administration. In order to guarantee the drug quality, supervision shall be reinforced on the drugs off production for long and producers with frequent personnel alteration and equipment alteration.

5. The drug producers under the jurisdiction of each municipal administration shall be timely notified to carefully check their own drug approval numbers. Causes shall be timely inquired from the registry of the provincial administration for drugs that have been applied for re-registration but have not been approved (excluding the injections without the research materials). Producers concerned shall explain causes to the local administrations for drugs that have not been timely applied for re-registration. Each municipal administration shall carefully collect and check the drug lists and report to the provincial administration prior to May 30.

6. Each municipal administration shall guide and urge producers to actively eliminate the drugs that are off production for long, with immature techniques, unstable in quality and of great risk. Producers that fail to apply for re-registration and reform the workshop due to the unqualified production conditions shall actively apply for the revocation of drug approval number.

May 4, 2011