Ten provinces and cities of China will carry out the marketing authorization holder (MAH) system for medical products under a trial program, the Chinese central government has decided.
Under the trial program, R&D organizations and researchers of medical products in Beijing, Tianjin, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan are allowed to apply for the drug approval number and assume the responsibility for drug quality.
In the past, only medicine producers had access to the drug approval number in China. Medicine producers had to get a drug approval number from China Food and Drug Administration before they could produce a certain medical product.
In the 10 provinces and cities involved in the trial program, the marketing authorization holders and producers of medical products are separated. The holders can entrust the production to different drugmakers and take the responsibility for the safety, effectiveness and quality of medical products.
The MAH system is expected to arouse enthusiasm of researchers and promote innovation in medical products, said Xu Jinghe, head of the law department under China Food and Drug Administration.
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