China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions

China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions

September 10, 2019, BioWorld

John Balzano is quoted in BioWorld regarding recent updates to China’s drug administration law and the establishment of marketing authorization holders (MAH). Mr. Balzano says, “This creates much-needed flexibility for research-based companies to develop products and bring them to market.” Another advantage of the MAH system is that licenses can officially be transferred. Previously, the license holders had to use makeshift pathways to transfer their licenses to other entities. Balzano said the new practice may increase flexibility for making deals. He added that the MAH system also allows for contract manufacturing at one or more locations and may ultimately create more centralized manufacturing and distribution of drugs. “China appears to want to have research-based companies be able to bring their products to the market and a strong biotech sector. It seems to want to have a more professional manufacturing sector to make things more consolidated,” he adds.