No permit for top vaccines in China
Chinas leading three hepatitis B vaccine producers have failed to obtain the government's permission and authorization for manufacturing new products. This can lead to a shortage in the hepatitis B vaccines and can affect the market. Recently, China Food and Drug Administration (CFDA), which is in charge of the country’s food and drug regulation, released an updated list of companies that have the Good Manufacturing Practices (GMP) certificate for their pharmaceutical products.In this list, the health regulator has included the names of top companies like Dalian Hissen BioPharm Co, Shenzhen BioKangtai and Beijing Tiantan Biological Products Corporation. The present standards related to good manufacturing practices (GMP) include stringent requirements that the pharmaceutical companies need to meet as regards their process of manufacturing and the quality of their manufacturing units.
According to the notification from CFDA, the companies that have failed to obtain the GMP certificate before the December 31, have been banned from manufacturing new products, however, they can continue selling their existing products.