Chinese pilot programme to streamline drug approvals evaluated at recent meeting

During a recent summit, co-organised by STA Pharmaceutical, the Shanghai Municipal Food and Drug Administration and the local government of the Jinshan District of Shanghai, the current state of the China Marketing Authorisation Holder (MAH) system was discussed.

Progress of the new pilot programme in streamlining drug approvals for the Chinese market was evaluated in the lengthy discussions that took place. One of the key components of the MAH system is that drug licence holders can now use a trusted manufacturer instead of needing to build their own facilities to market a drug within the country.

This new system is aimed at speeding up innovation and patient access to therapies and is coordinated with international standards for drug safety to keep patient risk low. It is anticipated that in the future the system will also find uses at a university level and for R&D institutions as well as for individual researchers.

The programme’s guidelines were created using other systems as inspiration, such as that which is implemented in the US. According to a press statement the director of the China Office at the US FDA, Dr Leigh Verbois, believes the success of the MAH system is a positive step towards the ‘globalisation of drug regulation’.

“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,” commented Dr Minzhang Chen, CEO of STA Pharmaceuticals during the meeting. “There is still a long way to go with the MAH, but in any case from a CMO point of view, the MAH can optimise resources so that Chinese patients can gain access to more new drugs faster and cheaper.”

STA Pharmaceutical is a subsidiary of WuXi AppTec and an open-access capability and technology platform for small molecule pharmaceutical development and manufacturing.