How many pharmaceutical companies are left? Look at the 2015 Annual Food and Drug Supervision Statistics Report


Release time:

2016-02-06


Abstract: As of the end of November 2015, there were 5065 API and preparation manufacturers nationwide. There are 466546 enterprises holding the "Drug Business License", including 11959 legal person wholesale enterprises and 1549 unincorporated wholesale enterprises. There are 4981 retail chain enterprises and 204895 retail chain stores. There are 243162 retail single pharmacies. A total of 2440 health food production licenses.
1. production and business license
(I) food production and business license
1. Food production licensing
In 2015, the bureaus of all provinces (autonomous regions and municipalities) issued 26228 new food production licenses and 217 new food additive production licenses. By the end of November, there were 170195 food production licenses and 3349 food additive production licenses, 131750 food production enterprises and 3288 food additive production enterprises.
2. Food business license
As of the end of November 2015, there were 8190702 food circulation licenses and 3486103 catering service licenses nationwide.
(II) health food production license
By the end of November 2015, there were 2440 health food production licenses nationwide.
(III) Pharmaceutical Production and Business License
1. Drug production license
As of the end of November 2015, there were 5065 API and preparation manufacturers nationwide.
2. Drug business license
As of the end of November 2015, there were 466546 "drug business license" enterprises in China, including 11959 legal person wholesale enterprises, 1549 illegal wholesale enterprises, 4981 retail chain enterprises, 204895 retail chain enterprise stores, and 243162 retail single pharmacies.
Production and operation license of medical devices in (IV)
1. Medical device production license
By the end of November 2015, there were 14151 medical device manufacturers in China, including 5080 in category I, 9517 in category II and 2614 in category III.
2. Medical device business license
As of the end of November 2015, a total of 186269 medical device operating enterprises (Class II and Class III) have implemented license management nationwide. There are 125197 enterprises operating Class II medical device products and 121984 enterprises operating Class III medical device products.
(V) Cosmetics Production License
As of the end of November 2015, there were 4542 hygiene licenses for cosmetics manufacturers.
2. Registration Approval
(I) health food registration
In 2015, 987 applications for initial registration of health food, 513 applications for change, 93 applications for technology transfer and 349 applications for further registration were approved.
(II) drug registration
In 2015, a total of 606 new drug clinical applications, 2 new drug certificates, 37 new drug certificates and approval numbers, and 48 approval numbers were approved. A total of 14 clinical applications, 24 new drug certificates and production applications and 37 production applications were approved according to the new drug application procedures.
Among them: in accordance with the provisions of the Measures for the Administration of Drug Registration, 1.1 to 1.5 categories in the chemical drug registration classification are approved for the production of 1 variety, and 88 clinical varieties are approved; 1 category in the biological product registration classification is approved for the production of 1 variety, and 19 clinical varieties are approved.
In 2015, 404 clinical applications for generic drugs and 143 production applications were approved.
In 2015, a total of 348 clinical applications for imported drugs were approved and 36 were listed.
In 2015, the General Administration approved 1623 supplementary drug applications and filed 871. The bureaus of all provinces (autonomous regions and municipalities) across the country have approved 7495 supplementary drug applications and filed 21659.
In 2015, the General Administration approved 341 applications for the production of packaging materials and containers that directly contact drugs, 349 applications for re-registration and 5 applications for import supplements. The provincial bureau approved 201 domestic supplementary applications.
(III) medical device registration
In 2015, a total of 11055 Class I medical devices were approved nationwide. 7029 Class II medical devices were registered for the first time and 4599 were renewed. 761 of the three types of medical devices were registered for the first time and 900 were renewed. Hong Kong, Macao and Taiwan registered 104 medical devices for the first time and continued to register 17. Imported medical devices registered 1559 for the first time and continued to register 1159.
Registration of (IV) Cosmetics
In 2015, a total of 4020 cosmetics for special purposes were approved for the first time, 623 were continued and 894 were changed. 9317 imported non-special cosmetics were approved for the first time, 837 were continued and 819 were changed.
3. Advertising Approval and Investigation
In 2015, a total of 29261 drug advertisements were approved nationwide, of which 20444 were filed in different places. 110690 illegal drug advertisements were transferred to the administrative department for industry and commerce. 164 pieces of drug advertising approval numbers were revoked.
In 2015, a total of 3853 medical device advertisements were approved nationwide, and 7546 illegal medical device advertisements were transferred to the administrative department for industry and commerce; 11 medical device advertisement approval numbers were revoked.
In 2015, a total of 5175 health food advertisements were approved nationwide, 30183 illegal health food advertisements were transferred to the administrative department for industry and commerce, and 100 health food advertisement approval numbers were withdrawn.
Protection of Traditional Chinese Medicine Varieties in 4.
As of the end of November 2015, there were 317 certificates of protected varieties of traditional Chinese medicine, including 114 varieties declared for the first time, 17 varieties of the same variety, and 186 extended protection periods.
5. complaints and reports
In 2015, food and drug regulatory departments at all levels accepted 409830 food complaints, filed 27402 cases and closed 27635 cases. Accepted 22608 complaints about health food, filed 996 cases and closed 896 cases. 39023 drug complaints were accepted, 3839 cases were filed and 4555 cases were closed. 9536 complaints about medical devices were accepted, 608 cases were filed and 764 cases were closed. 18812 complaints about cosmetics were accepted, 762 cases were filed and 958 cases were closed.
Investigation and handling of 6. cases
In 2015, the food and drug regulatory authorities investigated and dealt with 241834 food cases, involving a total value of 403.985 million yuan, a fine of 1045.488 million yuan, confiscation of 81.947 million yuan, investigated and dealt with 30659 unlicensed households, destroyed 743 fake dens, revoked 235 licenses and transferred 1618 to judicial organs.
In 2015, the food and drug regulatory authorities investigated and dealt with 5992 health food cases, involving a total value of 76.987 million yuan, a fine of 34.094 million yuan, confiscation of 3.23 million yuan, banning (investigating) 244 unauthorized production and operation households, and destroying 36 counterfeit production and sales dens. 318 households were closed for rectification and 143 were handed over to judicial organs.
In 2015, the food and drug regulatory authorities investigated and dealt with 89226 drug cases, involving a total value of 540.209 million yuan, a fine of 324.264 million yuan, confiscation of 91.086 million yuan, banning 1221 unlicensed businesses, destroying 165 fake dens, suspending 2959 businesses for rectification, revoking 77 licenses and handing over 1529 to judicial organs.
In 2015, the food and drug regulatory authorities investigated and dealt with 211 cases of drug packaging materials, involving a total value of 2.103 million yuan.
In 2015, the food and drug regulatory authorities investigated and dealt with 10760 medical device cases, involving a total value of 186.318 million yuan, a fine of 198.967 million yuan and a confiscation of 20.644 million yuan. They banned 145 unlicensed businesses, destroyed 19 fake production and sales dens, closed down 510 businesses for rectification, revoked 18 licenses and handed over 77 to judicial organs.
In 2015, the food and drug regulatory authorities investigated and dealt with 6139 cosmetics cases, involving a total value of 26.884 million yuan, a fine of 22.956 million yuan, confiscation of 14.025 million yuan, suspension of business for rectification of 260 households, and transfer of 14 cases to judicial organs.