SFDA issued a notice to strengthen the supervision of processing drugs entrusted by overseas manufacturers
Release time: 2011-08-03 & nbsp & nbsp & nbsp Source:
Business Club, August 2nd News July 26，National Food and Drug Administration (SFDA) issued a notice，Requires to strengthen the supervision and management of accepting processing drugs entrusted by overseas pharmaceutical manufacturers。
In recent years，Chinese pharmaceutical manufacturers accept the entrustment of overseas pharmaceutical manufacturers to conduct drug processing.，and develop faster，However, due to the different national drug supervision systems in the world，Drug management status is very complicated，Domestic enterprises blindly Stake Sports Bettingstake sports betting appcontract drug processing，illegal merchants at home and abroad use the production of counterfeit and shoddy products，Causes bad international impact。To maintain the national image，SFDA will strengthen the supervision and management of processed drugs entrusted by overseas pharmaceutical manufacturers，Strictly regulates the requirements of the commissioned processing behavior to make clear requirements。
Notification to point out，Provincial food and drug supervision and management departments must attach great importance to，Effectively strengthening drug manufacturers within the jurisdiction to accept the filing management of processing drugs entrusted by overseas pharmaceutical manufacturers，Strict review and accepting processed drug filing information entrusted by overseas pharmaceutical manufacturers。The client must be an overseas pharmaceutical manufacturer，And holding the drug abroad，and must sign a processing contract directly with domestic drug manufacturers。The authenticity and legitimacy of the document document of its drug listing permits are suspicious，It should be required to provide the commissioner to provide my country to the country in that country、Certification documents issued by the consulate。External labels or instructions of Trust Processing Drug Preparations must be marked with the name and address of the trustee processing enterprise，But there must be no approval number of Chinese medicines、Imported Drug Registration stake online sports bettingStake Sports BettingCertificate Number、Entrusted processing filing number and other content。
Drug production enterprises shall not accept overseas pharmaceutical manufacturers commissioned to process nude packaging preparations，The finished product should be completed after processing，and labels with the name of the drug and the name of the trusted processing enterprise。If a multinational company and other companies entrust internal commission to process nude packaging preparations，Relevant certification documents issued by the overseas drug management authorities。
Notification emphasis，Provincial food and drug supervision and management departments shall do a good job of filing in accordance with regulations，Injecting the "Receiving Drug Recruitment Form entrusted by the Overseas Pharmaceutical Manufacturer": "This table is only for the use of the filing certificate when it is subject to the supervision and inspection of the food and drug supervision and management department，The words must not be used as a listing license certificate provided to overseas institutions。For the filing application that does not meet the requirements，Should be informed that the enterprise will not record and reasons for the reason，Inform the relevant food and drug supervision and management department。
Provincial food and drug supervision and management departments shall strengthen the supervision and inspection of pharmaceutical manufacturers within their Stake Sports Bettingjurisdictions to accept overseas pharmaceutical My stake betting appmanufacturers，Interest into the Supervision and Inspection Plan，Interest into daily supervision。Production site inspections should include whether the enterprise strictly follows the recorded and processed location、Prescription、Craft、Quality and label description and other requirements，Whether to organize production in accordance with the "Regulations on the Management of Drug Production Quality Management"。For the annual processing of all year -round processing，A measures such as regular reports should be taken to strengthen supervision and management。During the supervision and inspection, if it is found that it is found without the record, it will be entrusted without authorization、Change the processing location or technical requirements of the recorded processing、Do not abide by the "Specifications for the Management of Drug Production Quality" and other behaviors，It must be ordered to correct it immediately，and deal with the "Measures for the Supervision and Administration of Drug Production" and relevant regulations。
Provincial food and drug supervision and management departments after receiving this notice，It is necessary to organize a comprehensive supervision and inspection of drug manufacturers in the area under the jurisdiction，Anyone who found that it does not meet the above requirements，It should be ordered to make corrections within a time limit，If the overdue does not meet stake online sports bettingthe requirements, it must Stake Sports Bettingbe ordered to stop processing。(Yang Junjian)
In recent years，Chinese pharmaceutical manufacturers accept the entrustment of overseas pharmaceutical manufacturers to conduct drug processing.，and develop faster，However, due to the different national drug supervision systems in the world，Drug management status is very complicated，Domestic enterprises blindly Stake Sports Bettingstake sports betting appcontract drug processing，illegal merchants at home and abroad use the production of counterfeit and shoddy products，Causes bad international impact。To maintain the national image，SFDA will strengthen the supervision and management of processed drugs entrusted by overseas pharmaceutical manufacturers，Strictly regulates the requirements of the commissioned processing behavior to make clear requirements。
Notification to point out，Provincial food and drug supervision and management departments must attach great importance to，Effectively strengthening drug manufacturers within the jurisdiction to accept the filing management of processing drugs entrusted by overseas pharmaceutical manufacturers，Strict review and accepting processed drug filing information entrusted by overseas pharmaceutical manufacturers。The client must be an overseas pharmaceutical manufacturer，And holding the drug abroad，and must sign a processing contract directly with domestic drug manufacturers。The authenticity and legitimacy of the document document of its drug listing permits are suspicious，It should be required to provide the commissioner to provide my country to the country in that country、Certification documents issued by the consulate。External labels or instructions of Trust Processing Drug Preparations must be marked with the name and address of the trustee processing enterprise，But there must be no approval number of Chinese medicines、Imported Drug Registration stake online sports bettingStake Sports BettingCertificate Number、Entrusted processing filing number and other content。
Drug production enterprises shall not accept overseas pharmaceutical manufacturers commissioned to process nude packaging preparations，The finished product should be completed after processing，and labels with the name of the drug and the name of the trusted processing enterprise。If a multinational company and other companies entrust internal commission to process nude packaging preparations，Relevant certification documents issued by the overseas drug management authorities。
Notification emphasis，Provincial food and drug supervision and management departments shall do a good job of filing in accordance with regulations，Injecting the "Receiving Drug Recruitment Form entrusted by the Overseas Pharmaceutical Manufacturer": "This table is only for the use of the filing certificate when it is subject to the supervision and inspection of the food and drug supervision and management department，The words must not be used as a listing license certificate provided to overseas institutions。For the filing application that does not meet the requirements，Should be informed that the enterprise will not record and reasons for the reason，Inform the relevant food and drug supervision and management department。
Provincial food and drug supervision and management departments shall strengthen the supervision and inspection of pharmaceutical manufacturers within their Stake Sports Bettingjurisdictions to accept overseas pharmaceutical My stake betting appmanufacturers，Interest into the Supervision and Inspection Plan，Interest into daily supervision。Production site inspections should include whether the enterprise strictly follows the recorded and processed location、Prescription、Craft、Quality and label description and other requirements，Whether to organize production in accordance with the "Regulations on the Management of Drug Production Quality Management"。For the annual processing of all year -round processing，A measures such as regular reports should be taken to strengthen supervision and management。During the supervision and inspection, if it is found that it is found without the record, it will be entrusted without authorization、Change the processing location or technical requirements of the recorded processing、Do not abide by the "Specifications for the Management of Drug Production Quality" and other behaviors，It must be ordered to correct it immediately，and deal with the "Measures for the Supervision and Administration of Drug Production" and relevant regulations。
Provincial food and drug supervision and management departments after receiving this notice，It is necessary to organize a comprehensive supervision and inspection of drug manufacturers in the area under the jurisdiction，Anyone who found that it does not meet the above requirements，It should be ordered to make corrections within a time limit，If the overdue does not meet stake online sports bettingthe requirements, it must Stake Sports Bettingbe ordered to stop processing。(Yang Junjian)
