All vaccine products in China will be tracked and supervised throughout their product lifecycle according to a newly passed law on vaccine administration, officials said at a press conference Saturday.
The law will take effect on December 1. Experts say that the move could be a milestone in vaccine safety, while bringing back market confidence in the regulatory system.
Passed by China's top legislature, the National People's Congress, on Saturday, the law requires "strictest" management by setting up a supervision system over the entire process and tougher penalties for producing and selling fake or substandard vaccines.
The full product lifecycle within the e-tracking system includes vaccine production, distribution and vaccination, the press briefing said.
"The National Medical Products Administration (NMPA) is working with the National Health Commission to build a nationwide vaccine tracking platform for supervision and regulation of enterprises," Yuan Lin, head of the drug supervision and management department under the administration, told the press conference.
Liu Junhai, a business law professor at Renmin University of China, told the Global Times that the tracking system is definitely an innovative move.
"Once the platform is in place, each vaccine will be traceable under the product profile. It will take just one scan to trace the producer, quality check and distribution process. Thus, consumers will regain their confidence and regulation efficiency will be improved too," Liu elaborated.
Technical standards and specifications for drugs, including vaccine traceability have been published by the NMPA since last year.
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.