The measures were made public as the draft revisions are under review at the ongoing session of the Standing Committee of the National People's Congress (NPC).
The draft requires individuals and entities who have become medicine marketing authorization holders (MAHs) be responsible for the drugs' clinical and non-clinical trials, manufacturing, selling, and the analysis, report, and response of adverse reactions.
The MAHs should sign agreements with manufacturers, sellers, transporters, and keepers of the drugs to make sure they are capable of maintaining the quality of drugs and managing risks, the draft says.
"The draft makes it clear that MAHs must be responsible for the full 'life-cycle' of drugs," said Tang Minhao, head of the Shanghai Association of Food And Drug Safety. "The MAHs will become the primary target of drug supervision."
The MAH system has been introduced in selected cities and regions for more than four years in a pilot reform.
Latest comments