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MAH system reaches BDA

Updated: 2021-04-15

After the drug marketing authorization holder system (MAH) takes effect in China, market entities with drug technology but no production plants can also apply for a drug marketing license and obtain drug marketing license approvals, which means that drug R&D companies no longer simply provide technology but can also participate in the entire life cycle of drug R&D, production, and sales.

On March 23, Atorvastatin Calcium, the first product developed by Beijing Hicrystal Biomedical Technology Co., Ltd. in the Beijing Economic and Technological Development Area (BDA) was approved for listing. 

Why was it decided to establish Hicrystal in the BDA? Cao Xianglin of Hicrystal said that to promote the listing of R&D drugs through the MAHder system, it is necessary to integrate a large number of industry resources, like testing, verification and other supporting services required in the drug R&D stage.

After the laboratory R&D completes the transfer of results and the industrialization stage, production needs to be commissioned. The high concentration of biomedicine resources in the BDA meets the needs of enterprises like Hicrystal.

The BDA has gathered more than a thousand companies in the biomedical field, including Bayer, Tide Pharmaceutical, and Tongrentang, forming a complete industrial chain covering biomedicine, medical equipment, the health industry and other fields, with a focus on biotechnology, targeted drugs, cell therapy, genetic testing, smart medical equipment, telemedicine and other emerging business formats.