CFDA: In 2013, there were 4,875 pharmaceutical companies in China

December 23rd, the CFDA published the 2013 Annual Report on Food and Drug Regulatory Statistics through its official website. Here are some of the contents related to the pharmaceutical industry. Several figures are worth noting: in 2013, there were 4,875 api and preparation production enterprises nationwide, and in 2013, 148 new drugs were approved clinically, 4 new drug certificates, 66 approval numbers, 45 new drug certificates and approval numbers.
drug registration
in 2013 approved 148 new drugs clinically, 4 new drug certificates, 66 approval numbers, new drug certificates and approval numbers 45. (Among them: according to the Measures for the Administration of Drug Registration, 1 to 5 categories in the registration classification of Traditional Chinese medicines and natural medicines are approved for the production of 0 varieties and 0 varieties for clinical treatment; 1.1 to 1.5 categories in the classification of chemical drugs are approved for the production of 2 varieties, 82 varieties for clinical approval; and 1 category for the registration classification of biological products is approved for the production of 1 variety and 4 varieties for clinical approval.) In
2013, 120 clinical applications, 0 new drug certificates, 6 new drug certificates and 32 production documents were approved in accordance with the application procedure for new drugs.
approved 92 clinical applications for generic drugs and 176 for production in 2013.
approved 251 clinical applications for imported drugs and 17 applications for listing in 2013.
2013, the General Administration approved a total of 2,055 additional drug applications, 530 for the record. A total of 5,385 additional drug applications were approved by provincial bureaus nationwide, and 20153 were filed.
in 2013, the General Administration approved 571 applications for the production of packaging materials and containers for direct contact with drugs, 506 re-registration applications, 19 import supplementary applications, and 140 domestic supplementary applications approved by the provincial bureau.
pharmaceutical, medical equipment, health food, cosmetics production enterprises
As of the end of 2013, there were 4,875 api and preparation production enterprises nationwide.
the end of 2013, there were 15,698 medical device manufacturers nationwide, including: 4,218 I. medical device manufacturers, 8804 Class II. medical device manufacturers, and 2,676 Class III medical device manufacturers.
the end of 2013, there were 2,616 health food production enterprises in China.
the end of 2013, there were 4,015 cosmetics manufacturers nationwide.
Medical Device Registration
In 2013, a total of 4,252 class I medical devices were approved for the first time and 3,738 were re-registered; Approved 1030 first registrations of Class III medical devices, re-registration of 1852, initial registration of 229 medical devices in Hong Kong, Macao and Taiwan, re-registration of 66 cases, first registration of imported medical devices 3,916 cases, re-registration of 3,798.
The situation of pharmaceutical and medical device business enterprises
As of the end of 2013, there were 451,129 enterprises holding "drug business licenses" in China, of which 12,849 were legal persons wholesale enterprises and 2,051 were illegal wholesale enterprises;
the end of 2013, there were 183,809 medical device operating enterprises operating license management (Class II, Class III. medical devices) nationwide.
approval and investigation of drug
in 2013, a total of 30,662 drug advertisements were approved nationwide, of which 21,092 were filed offs site. 160,917 illegal drug advertisements were transferred to the administrative department for industry and commerce;
2013, a total of 2,773 medical device advertisements were approved nationwide, and 20,438 illegal medical device advertisements were transferred to the administrative department for industry and commerce;
2013, a total of 4,217 health food advertisements were approved nationwide, and 28,903 illegal health food advertisements were transferred to the administrative departments of industry and commerce;
The protection of Chinese medicine species
By the end of 2013, there were 504 certificates of protection of Chinese medicine species, of which 131 were initially declared varieties, 20 were of the same variety, and 353 were extended.
the number of complaints reported and filed
in 2013 a total of 45,908 drug complaints were received, of which 7,325 were filed and 6,180 were closed. 9760 complaints were received about medical devices, of which 1,426 were filed and 1,193 were closed. Of the 16,142 complaints received about health food, 1,317 were filed and 1,101 were closed. 4,372 cosmetic complaints were received, of which 396 were filed and 319 were closed.
cases of illegal drugs and medical devices
147,322 drug cases and 72 cases of more than 1 million yuan were investigated and dealt with throughout 2013; The total value of the articles involved was 982.799 million yuan, the fine amount was 412.47 million yuan, the confiscation amount was 88.17 million yuan, 2495 households were banned from operating without a license, 608 false nests were destroyed, 2009 households were closed for rectification, 193 permits were revoked, 2337 cases were handed over to judicial organs, 508 people were criminally punished, and 2525202 people were supervised and inspected.
2013, a total of 19792 cases of medical devices, more than 1 million cases 16 cases; The total value of the articles involved was 13.6852 million yuan, the fine amount was 10.4246 million yuan, the confiscation amount was 2.5821 million yuan, 932 undocumented operations were banned, 48 false nests were destroyed, 221 were closed for rectification, 6 permits were revoked, 81 were handed over to judicial organs, 10 criminal penalties were imposed, and 1123,716 people were supervised and inspected.
Administrative Reconsideration, Administrative Litigation
In 2013, 452 administrative reconsiderations were accepted by the state-owned food and drug regulatory departments at all levels, and 93 administrative litigation cases against the food and drug supervision and administration departments at all levels were accepted by the courts. (Biological exploration)