Industry calls for exposure to drug safety blacklist

On October 1, 2012, the “Blacklist for Pharmaceutical Safety” Management Regulations (Trial) formulated by the State Food and Drug Administration was formally implemented. According to the regulations, the food and drug supervision and administration department at or above the provincial level should set up a “drug safety” blacklist “column” on the prominent site of its government affairs website, and include the unqualified producers, managers, and persons responsible in the administrative area into drug safety.” Blacklist, and updated by special management.

Recently, Li Yingjie, a Henan public-goods person who has long paid attention to drug safety, conducted a special investigation and found that in the 33 provincial drug administration department’s administrative websites, the “drug safety” blacklist “column” was not set on the 32 administrative website homepages. The Food and Drug Administration of the Tibet Autonomous Region did not even have a government affairs website.

The release of illegal drug information is also not optimistic. While investigating whether the provincial drug administration department’s government affairs website has set up blacklist sections in accordance with the regulations, Li Yingjie also conducted a simple investigation on the situation of these government websites publishing illegal drug information. The results are equally not optimistic. .

According to the survey, among the 32 government affairs website homepages, only 16 government affairs website homepages have columns for drug safety information. However, of the 16 drug safety information columns, there are 5 websites whose column information has been lagging behind, with 7 sites being The column information was too simple. The public could not obtain effective information. There were 3 websites whose columnists had false names - no drug safety information. There was even a column in the website that completely reprinted illegal drug information in other places. Through these columns, consumers simply cannot obtain information in a timely and effective manner.

The letter proposed to improve regulations and strengthen implementation on December 11. According to the investigation results, Li Yingjie sent a letter of recommendation to the State Food and Drug Administration. Li Yingjie stated in the proposal letter that since the administrative inaction of the provincial drug administration department led directly to the blacklist of drug safety, it did not achieve the intended purpose. The drug regulatory department also had many problems in the disclosure of illegal drug information.

The letter proposed that the State Food and Drug Administration should establish a “drug safety” blacklist “column” on the homepage of the government affairs website as soon as possible in accordance with regulations and urge the food and drug supervision agencies (drugs supervision and administration bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government, food and drug supervision of the Xinjiang Production and Construction Corps. The Authority will adopt the same measures in accordance with the regulations and establish the publication channels for drug safety blacklists as soon as possible.
Drug safety cannot be separated from the "black list"

Cheng Yuan, executive director of the “Nanjing Tianxia Public Agency”, a public interest organization that has long been concerned with food and drug safety, believes that the establishment and publication of drug blacklists can greatly shake up unscrupulous units and personnel, supervise and warn producers and operators to fully fulfill their responsibility for quality and safety, and society The public can also easily understand the situation of drug safety through the blacklist to avoid harm. It is crucial to maintaining the order of the pharmaceutical market and safeguarding the health and safety of the public. Safeguarding drug safety requires such a “blacklist”, which is also in line with the National Development and Reform Commission. With regard to the spirit of further strengthening the guidelines for the construction of the drug safety credit system, since the SFDA has made regulations, it should take the lead in implementing it and strictly supervise the implementation of the subordinate units.

The importance of drug safety blacklists for maintaining drug safety is self-evident. If the investigation is true, no province-level drug regulatory department in the country will set up drug blacklist columns according to regulations. The results will inevitably disappoint the public. The administration according to law is the basic requirement for the administrative department. The important point contained in the administration according to law is that the law must be adhered to. The actions of the provincial pharmaceutical supervisory department will greatly impair the credibility of the government department. Therefore, it is recommended that the State Food and Drug Administration urge the provincial drug administration as soon as possible. The department implements the regulations and investigates the administrative responsibilities of the responsible personnel.