China has introduced a new law on vaccine administration which toughens penalties on the production and sale of fake or substandard vaccines, China Daily reports.
The law, which was adopted by the country’s top legislature on Saturday, also calls for strict management and supervision of the “whole process.”
The new law, which takes effect on December 1, 2019, stipulates that supervision of vaccines will cover the whole process, from vaccine development, production and distribution, to vaccination.
Specialized inspection teams of pharmaceutical professionals will be established at the central and provincial levels to conduct the supervision.
An electronic information system will be set up to make all information relating to vaccines trackable, such as production and package information of vaccines, period of validity, date of vaccination, and medical workers who conduct the vaccination and the recipients. The records must be retained for at least five years after the expiry of the vaccine, according to the law.
To increase transparency of the industry, vaccine licence holders are required to publish vaccine information on their websites in a timely manner, including product instructions and labels, official approval, recall information, inspections and punishment received and compulsory insurances covered.
The new law also toughens penalties on the production and sale of fake or substandard vaccines. It stipulates that people whose violations constitute a crime shall bear heavier criminal responsibility in accordance with the law.
As well, producers and sellers of defective vaccines will face a fine of 15 to 50 times the value of the illicit products, while substandard vaccine makers or sellers face a fine of 10 to 30 times the value.
The threshold for fines will also be raised, where fake or substandard vaccines worth less than 500,000 yuan ($72,908) shall be calculated as 500,000 yuan. Production and business operations can also be suspended and pharmaceutical production licences can be revoked.
Production and business operation will be suspended for rectification, and drug registration certificates or even pharmaceutical production licenses can be revoked, it said.
Jiao Hong, head of the National Medical Products Administration, said the law will further enhance the quality of the country’s vaccines and boost the public’s confidence on vaccine safety.