China puts too many liabilities on MAHs

China made the marketing authorization holder (MAH) scheme official in the country in December last year after running it as a three-year pilot program. The move was largely welcomed by China’s pharma industry, especially start-ups which have the research capacity but lack the funds to build a manufacturing facility.

However, the current MAH policy still has a lot of room to improve, particularly in terms of defining MAH’s responsibilities, said several speakers at a two-day conference held by the local consulting company Pharma DJ on August 20 in Shanghai.

“Under the current regulation, a Chinese MAH has too many responsibilities compared to its counterparts in the US and EU,” said Wang Gang, chief quality officer at the Shanghai-based Junshi Bioscience who also has extensive experiences with the European Medicines Agency and the US Food and Drug Administration on regulatory matters.