Greater scrutiny on vaccines

Chinese govt imposes higher levels of quality control

BEIJING: Drug regulators and vaccine producers will face intensified scrutiny to ensure product safety and quality, said a top drug supervision official.

Vaccines are a major public health issue because they involve matters of life and death as well as national security, and efforts are now being made to establish an effective supervisory mechanism over vaccines, said Jiao Hong, head of the China Medical Products Administration.

To ensure effective supervision over the sector, the administration will focus on urging vaccine producers and local drug authorities to carry out their respective duties, Jiao said at a news conference in Beijing during the annual sessions of China’s top legislative and advisory bodies.

Vaccine producers must take measures to ensure the quality of their products, including establishing sound quality control systems and product tracing systems, and also implement product risk report regulations, she said.

The administration will further clarify supervisory responsibilities on the part of local drug authorities, and urge provincial-level drug authorities to intensify site inspections over vaccine producers, she said.

The administration will increase patrols and random inspections over vaccine producers across the country, and severely punish violators, Jiao said.

Meanwhile, it will improve training of drug inspection officers to improve their efficiency, she said.

The safety and quality of drugs have been a major public concern over the past few years in China, with reports of alarming incidents such as the use of expired vaccines.

Changchun Changsheng Bio-tech Co, a major producer of a rabies vaccine in Jilin province, was found by China’s top drug regulator last year to have committed various violations such as using expired materials and faking production over a four-year period.

Although no deaths or injuries linked to the case have been reported, the incident shocked the nation, prompting top officials to vow intensified supervision over the sector.

A new law, the Vaccine Administration Law, which imposes much higher penalties on violators, was drafted and submitted to the top legislature for review at the end of last year. — China Daily/Asia New Network