China's MAH pilot forecast to provide further opportunities for international pharma

China’s detailed pilot plan for the Marketing Authorization Holder (MAH) system, which is seen as a revolutionary process in the development of biopharmaceutical innovation in the country, will be discussed at CPhI & P-MEC China – organized by UBM EMEA and UBM SINOEXPO and set to take place June 20-22.

The new system allows the license holders of a drug to sell in China using a contract manufacturer, instead of manufacturing the drug themselves. This makes it easier for the growing number of Chinese biotech’s to progress their own products through clinical development; they are no longer required to invest in their own manufacturing facilities. However, it also means that foreign drug license holders can now use contract facilities in China, providing much easier access to the market. This year, with the MAH now underway, it is perhaps unsurprising that the number of international attendees at CPhI China is expected to grow by 15% – as they look to capitalize on the domestic market, which continues to grow at double digit pace, the conference organizer commented.

China is a pharmerging giant, with around 6,500 pharmaceutical manufacturing companies producing 1,500 types of ac0tive pharmaceutical ingredients (APIs), the biggest production being Vitamins C and E, penicillin, and paracetamol. In addition, there are 16,000 medical device and equipment manufacturing companies, which produce about 3,000 kinds of products such as MRI and CT.