(Yicai Global) Oct. 9 -- The General Office of China's State Council, its cabinet, has issued guidance on driving innovation in the country's drug and medical devices sector through reforming clinical trial management, accelerating drug review and approval, promoting medical innovation and developing generic drugs, state-run Xinhua News Agency reported yesterday.
The guidance calls for strengthening of the full life-cycle management of medicines and medical equipment, the improvement of related technologies and enhanced organization.
The office's opinions call for better regulation of drug promotions and the publishing of authorized drug marketers and their related representatives on regulator websites.
Drug representatives are responsible for marketing medicines, introducing them to medical workers and listening to opinions and recommendations about their clinical uses. They should register with public departments and should not be tasked with selling medicines, Xinhua stated.
China's government warns that representatives who mislead doctors about drug uses or their adverse effects will be severely punished and those who sell medicines will also be reprimanded.
The country strictly controls injection preparations converted from oral medicines and does not approve injections if there are enough oral preparations to satisfy clinical demand. Likewise, regulators do not approve intravenous injection preparations if there are enough intramuscular injection preparations to satisfy demand.
Applications for switches between large dose injections, small dose injections and aseptic powder needles for injection use will not be approved if there are no substantial clinical advantages.