China Update: New Device GMPs and a World-First Vaccine Approval

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China Revises Device GMPs

China’s Food and Drug Administration (CFDA) has issued revised current medical device good manufacturing practices (GMPs) that require manufacturers to implement quality management systems covering product design and development, manufacturing, and sales, including after-sales services.

Manufacturers must also maintain records on product design and development, production, testing, purchasing, sales, and after-sale services. In addition, the quality management system must also cover the operation, cleaning, and maintenance of the manufacturing equipment and facilities.

The revised GMPs take effect 1 March 2015.

CFDA Announcement

China Approves World's First Sabin Strain Inactivated Polio Vaccine

CFDA has announced the marketing approval of the world’s first Sabin strain inactivated polio vaccine. The vaccine was developed independently by China’s Institute of Medical Biology at the Academy of Medical Sciences.  The agency acknowledges the assistance of the World Health Organization (WHO), the US Centers for Disease Control (CDC), Japan’s National Institute of Infectious Diseases (NIID), the European Medicines Agency (EMA), and the UK, in the review of the vaccine. 

China intends to provide the vaccine to developing countries through the WHO’s polio eradication program.

CFDA Announcement