In the field of drug supervision in 2023, according to the CIO** regulatory inspection, a total of 2,801 penalty data have been released from the relevant penalty information collected by the State Food and Drug Administration and the provincial and municipal food and drug administrations, covering almost all provinces and municipalities directly under the central government, of which 2,313 companies have been sanctioned by law. Behind these figures is the firm commitment of the State Food and Drug Administration and the provincial and municipal food and drug administrations to drug safety, as well as a strong guarantee for public health.
Enterprises are the main body of drug production and circulation, and their compliance operation is directly related to drug safety. In the enterprise sector, the punishment data of enterprises in the pharmaceutical field in 2023 will be as high as 2,313, involving 393 production enterprises, 1,852 operating enterprises, and 68 user units. These data show that from production to distribution to use, every link of drug supervision cannot be ignored.
From the perspective of regional distribution, the punishment information throughout the year involved a total of 31 provinces and cities across the country, and the information in Guangdong, Liaoning, Xinjiang, Anhui, and Ningxia accounted for an obvious proportion, and the data was outstanding. The high penalties in these regions may be related to the size of the local drug market, the strength of regulation, and the compliance awareness of enterprises. The high penalty rates of regulators in these regions reflect a zero-tolerance approach to drug safety issues, and also suggest that regulatory strategies need to be more refined to ensure that the same safety standards are met in each region.
From the perspective of punishment situations, a total of 31 punishment situations will be involved in the whole year of 2023, of which 11 situations will be involved in production enterprises, 24 types of operating enterprises, and 9 types of user units. The amount of fines and confiscations amounted to up to one million, and a total of nine companies had their licenses or registration certificates revoked. The above-mentioned penalty data reveals many problems in the production and distribution of drugs. Among them, the production, sales and use of inferior drugs are particularly prominent, and 510 enterprises have been punished for this. The specific reasons for punishment are concentrated in: the content of the drug ingredients does not meet the national drug standards, the drug exceeds the use period, and the drug does not meet other drug standards. In the case of inferior drugs, the maximum fine for the production enterprise is 140 million yuan, the maximum fine for the operating enterprise is nearly 65 million, and the maximum fine for the user unit is more than 1 million yuan. The actions of these companies not only violate the Drug Administration Law, but also pose a serious threat to the health of consumers. Against this backdrop, the huge amount of fines and confiscations, as well as the revocation of business licenses or registration certificates, demonstrate the determination of the regulators. These severe penalties have undoubtedly sounded the alarm bell for the entire industry, reminding all companies that they must strictly comply with drug production and quality standards.
In the next article, we will continue to take you to review the drug regulatory information in 2023, and sort out and analyze the content of the personal and product sections for you, so stay tuned.