Guilty producers will be publicly named and shamed and may be prosecuted

A regulation on the management of a drug safety blacklist will take effect on Oct 1, the State Food and Drug Administration said on Sunday.

The new regulation stipulates that people who produce drugs illegally, who seriously violated regulations on drugs and medical devices and who were subject to administrative punishment will be blacklisted and named on an official government website so they can be supervised by the public, the administration said.

"Establishing the blacklist for drug safety strengthens safety supervision and the administration of drugs and medical devices, promotes the construction of a credit system and improves the industry’s entry and exit mechanism," said a statement released by the administration on Sunday.

"Meanwhile, it will also be conducive to supervising the producers to fully assume their responsibility for drug quality and safety and deterring illegal behavior," it added.

According to the regulation, illegal drug producers who receive administrative punishment in seven kinds of situations will be included on the blacklist.

The first situation is that their licenses for the production of drugs and associated operations, or permits for working with medical institutions, were revoked for manufacturing or selling fake or substandard medicine.

The second is that they didn’t obtain a certificate to produce medical devices or produced ones that didn’t accord with national regulations and industry standards or manufactured and sold medical devices of poor quality that resulted in serious medical malpractices, or their permits for the manufacture and operation of medical devices had been revoked.

Others include: concealing the real situation or providing false materials when applying for administrative permits; using deception, bribery or other improper means to receive administrative permits; counterfeiting; deliberate destruction of an incident scene; concealing or destroying evidence; refusing or escaping supervision when under investigation of administrative penalty; being criminally accountable for illegal behavior involving drugs or medical devices, and producing or selling drugs or medical devices that cause serious medical incidents due to violation of laws and requirements.

"It’s necessary to implement a blacklisting system for the safe administration of drugs and so people can purchase drugs of a good quality and safely use medical devices to treat their diseases," said Sun Zhongshi, a professor with the national monitoring center for the rational use of medication under the Ministry of Health.

"Previously, manufacturing and selling fake medicine was rampant across the country. It posed a big risk to people’s health," he added. "The blacklist will send a strong signal to medicine-producing enterprises that they are under the supervision both of the public and the administrative authorities. Once enterprises involved in the illegal production of drugs are blacklisted and publicly named, their business will face complete collapse and even a criminal penalty if the situation is serious. Therefore the administrative authorities will take the blacklist seriously and make public enterprises that behave illegally after acquiring solid evidence."

Office regulation

On Oct 1, the regulation on the administration of government offices will also be formally introduced. It aims to control the scale and undertaking of official business tours abroad, official vehicles, as well as official receptions.

According to the ordinance, governments at all levels are required to strengthen their management of meetings, control the number and size of conferences and make full use of public office space, audio and video systems.

Moreover, it stipulates that government departments should strictly implement the provisions on official business trips abroad and examine the reasons, agenda and schedules of civil servants who travel on business, as well as controlling the number of those who take the trips.

During trips abroad, civil servants shouldn’t arrange study or training that is irrelevant to their work, it added.

zhangyan1@chinadaily.com.cn