All vaccine products in China will be monitored and monitored throughout the product life cycle, according to the recently adopted vaccine control law, officials said at a news conference on Saturday.
The law will come into force on December 1st. Experts say that this move could be a milestone in vaccine safety while at the same time restoring market confidence in the regulatory system.
Adopted by the Chinese National Parliament, the National People's Congress, on Saturday, the law requires "the most stringent" management of the establishment of a system of oversight over the entire process and stricter penalties for the production and sale of false or low quality vaccines.
The overall product life cycle of the e-monitoring system includes production, distribution and vaccination of vaccines, the statement states.
"The National Agency for Medical Products (NMPA) co-operates with the National Health Commission to build a national surveillance and control company surveillance platform," said Yuan Lin, head of the drug management and management department at the press conference. .
Liu Junhai, professor of business law at Renmin University in China, told the Global Times that the monitoring system is definitely an innovative move.
"When a platform is set up, every vaccine will be able to be tracked under a product profile. Only one scan is needed to monitor the manufacturer's process, quality assurance, and distribution, so consumers will regain their trust and improve the efficiency of the regulation," Liu explained.
NMPA has published technical standards and specifications for drugs since last year, including traceability of the vaccine.
For a vaccine monitoring system, the law requires vaccination information, including vaccine data, expiration date, and date of use, while medical staff issuing vaccines and their recipients should be recorded and kept for at least five years after the expiration date.
The new law on vaccine management combines all regulations. According to top-down authority, the law will facilitate the work of all subjects, Yuan said.
There are 45 vaccine manufacturers in China that produce more than 60 types of vaccine to prevent 34 types of diseases, with an annual capacity of more than 1 billion doses, said Jiao Hong, head of NMPA, 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 pointed out.
Some of these vaccine manufacturers are listed in the international procurement list and are exported to countries in the Belt and Road Initiative.
"We encourage 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 incident with the vaccine last year exposed problems in the company's internal controls and failure in the regulatory system, and the new law will allow regulators to shut up prisoners and curb the risks of vaccine management, Liu said.