New Tougher Law to Govern China’s Vaccine Industry Starting December 2.0

The notorious scandal of Changsheng Biotechnology producing fake vaccine panicked the public. The vaccine incident case exposed issues in companies’ internal controls and failure in the regulatory system, and the new law will enable the regulators to close loopholes and rein in risks in vaccine management. Hence, technical standards and specifications for drugs, including vaccine traceability have been published by the NMPA since last year, officials said at a press conference in China.

It is normal to see that almost every Chinese kid vaccinates after birth nowadays. As per school’s requests, F-1 students purchase International Student Health Insurance (aka 留学生 保险) to get required vaccine covered in American insurance (aka 美国保险 疫苗) plan, and visiting scholars buy required J-1 visa insurance (aka j1 签证 保险). Some purchase OPT insurance (aka opt 保险) or H-1B medical insurance (aka h1b 医保) after graduation. The vaccine safety incident has become a heated topic prevailing among all international students who have purchased or are going to purchase American health insurance (aka 美国健康保险) covering some types of vaccine. They strongly advocate the stricter rules to be effective in China ASAP.

For the vaccine tracking system, the law requires vaccination data, including a vaccine’s information, expiry date and use date, while medical workers who issue the vaccines and their recipients should be recorded and retained for at least five years after its expiry.

The new law on vaccine management integrates all regulations. With top-down authority, the law will help facilitate the operation of all subjects, said Yuan.

There are 45 vaccine producers in China that produce more than 60 types of vaccines to prevent 34 kinds of diseases, with an annual capacity of more than 1 billion doses, Jiao Hong, head of the NMPA, said at the press conference.

“China is one of the few countries in the world that can become self-sufficient with all planned immunization vaccines according to their own abilities,” Jiao noted.

Some of these vaccine producers have been listed in the international procurement list and export to countries in the Belt and Road Initiative.

“We are encouraging high-quality medical producers from China to enter the international market and effectively improve China’s participation in the global healthcare cause,” she said.

The vaccine incident case last year exposed issues in companies’ internal controls and failure in the regulatory system, and the new law will enable the regulators to close loopholes and rein in risks in vaccine management, Liu said.