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China FDA, US FDA and industry leaders debate MAH pilot being adopted nationwide

STA Pharmaceutical Co., Ltd. (STA)  – a WuXi AppTec subsidiary and a leading open-access capability and technology platform for small molecule pharmaceutical development and manufacturing – co-organized a summit along with the Shanghai Municipal Food and Drug Administration and the local government of the Jinshan District of Shanghai on the current state of the China Marketing Authorization Holder (MAH) system, currently being piloted in ten provinces and municipalities across China.
Discussions ran for several hours and were centred on the progress of the new MAH system in streamlining drug approvals for the China market.  A key feature of the pilot program is licence holders of a drug can now use an entrusted manufacturer instead of losing time to build their own facilities, as was formerly required, in order to market a drug in China.
The system coordinates with international standards for drug safety to keep patient risk low, while stimulating innovation, and speeding patient’s access to life saving therapies. A leader from the Shanghai Food and Drug Administration explained that the idea of the approval system reform was first conceived in 2015 in Shanghai, one of China’s leading pharmaceutical and research hubs. The main purpose of the system was to ‘further drive research and development, encourage drug innovation and stimulate scientific researchers’. He even goes on to add that in the future, it won’t only be just biotech and pharma companies that can utilize the MAH, but also universities, R&D institutions and even individual researchers.
The pilot program guidelines are based around other foreign systems that China has looked to for inspiration, including the USA. Dr Leigh Verbois, Director of the China Office at the US FDA, touted the success of the pilot over the past year as a huge positive step forward in ‘the globalization of drug regulation’.
Dr. Leigh also went on to say that China’s movement towards a similar regulatory system as other major pharma economies helps to mitigate risk. “This is what we want to be able to ensure that no matter where you are, perhaps in China or other parts of the United States, the product risk you encounter may be the same.”
Dr. Minzhang Chen, CEO of STA Pharmaceuticals, rounded off the session with first-hand view of what it’s like to be a participant within the scheme. He commented that more and more domestic and foreign customers had begun to co-operate with STA on the MAH since its launch in 2016. “So far we have supported more than a dozen customers of the MAH with new drug clinical approval and on-site verification, of which two customers have passed the (MAH) listing licence application.”
Dr. Chen acknowledged that this was only the beginning, commenting, “There is still a long way to go with the MAH, but in any case from a CMO point of view, the MAH can optimize resources so that Chinese patients can gain access to more new drugs faster and cheaper.” The panel went on to agree that it is a very interesting time for the Chinese pharma market, with the possibility of opening up more innovative research and pushing China ahead as a global leader in drug development.