2017 annual report of food and drug supervision statistics

Source: CFDA 2018-04-04 I production and operation license (I) food production and operation license (I) Food production license (2017) A total of 17000 new food production licenses and 231 food additive production licenses were issued by provincial (District, city) bureaus By the end of November, there were 159000 food production licenses, 3695 food additive production licenses, 149000 food production enterprises and 3685 food additive production enterprises in China 2 As of the end of November 2017, there were 12.843 million food operation licenses (including food circulation licenses and catering service licenses still in validity) in China, including 8.963 million new food operation licenses, 2.675 million old food circulation licenses and 1.224 million old catering service licenses 3 As of the end of November 2017, there were 2317 health food production licenses in China （2） Drug production and marketing licensing 1 As of the end of November 2017, there were 4376 enterprises producing APIs and preparations in China 2 As of the end of November 2017, there were 472000 drug licensing enterprises in China, including 13000 wholesale enterprises, 5409 retail chain enterprises, 229000 retail chain stores and 225000 retail pharmacies （3） Production and operation license of medical devices 1 By the end of November 2017, there were 16000 medical device manufacturers in China, including 6096 enterprises that can produce class I products, 9340 enterprises that can produce class II products and 2189 enterprises that can produce class III products 2 As of the end of November 2017, there were 410000 class II and class III medical device enterprises in China, including 225000 class II medical device enterprises, 61000 class III medical device enterprises, and 124000 class II and class III medical device enterprises （4） By the end of November 2017, there were 4304 production / hygiene licenses for cosmetics manufacturers 2、 Registration approval (I) registration of special food in 2017, 797 applications for initial registration of health food, 1101 applications for change of registration and 348 applications for renewal of registration were approved In 2017, 952 applications for formula registration of infant formula milk powder products were approved In 2017, 3 applications for registration of formula food for special medical purposes were approved （2） Drug registration in 2017, a total of 734 new drug clinical applications, 20 new drug certificates and approval documents, and 9 approval documents were approved in the new drug approval work; a total of 42 clinical applications were approved according to the new drug application procedure In 2017, 251 clinical applications for generic drugs and 224 production applications were approved In 2017, a total of 316 clinical applications for imported drugs were approved and 93 were listed In 2017, the General Administration approved 2158 supplementary drug applications and 546 for filing A total of 4251 supplementary drug applications were approved and 12264 were put on record by the provincial (District, city) bureaus In 2017, a total of 552 applications for production of packaging materials and containers in direct contact with drugs were approved, 338 applications for re registration and 62 supplementary applications （3） Registration of medical devices in 2017, China approved the first registration of 5993 domestic class II medical devices, 867 domestic class III medical devices, 389 imported (including Hong Kong, Macao and Taiwan) class II medical devices and 189 imported (including Hong Kong, Macao and Taiwan) class III medical devices It is approved to continue the registration of 7193 domestic class II medical devices, 1616 domestic class III medical devices, 1655 imported (including Hong Kong, Macao and Taiwan) class II medical devices and 1631 imported (including Hong Kong, Macao and Taiwan) class III medical devices There are 4584 changes in Category II medical devices, 489 changes in category III medical devices, 555 changes in Category II medical devices for import (including Hong Kong, Macao and Taiwan), and 591 changes in category III medical devices for import (including Hong Kong, Macao and Taiwan) （4） Cosmetics registration in 2017, a total of 2537 special-purpose cosmetics were approved for the first application, 979 for renewal and 2510 for change; 12683 non special-purpose cosmetics were approved for the first record, 3163 for renewal and 1300 for change 3、 In 2017, 12000 drug advertisements were approved nationwide 8774 illegal drug advertisements were transferred to the administrative department for Industry and commerce 389 approval numbers of drug advertisements were revoked In 2017, a total of 17000 medical device advertisements were approved nationwide, 1087 illegal medical device advertisements were transferred to the administrative department for Industry and commerce, and 18 approval numbers of medical device advertisements were revoked In 2017, a total of 7029 health food advertisements were approved nationwide, 2312 illegal health food advertisements were transferred to the administrative department for Industry and commerce, and 40 approval numbers of health food advertisements were revoked 4、 As of the end of November 2017, there were 237 certificates of protected varieties of traditional Chinese medicine, including 110 varieties declared for the first time, 12 of the same varieties and 115 of extended protection period 5、 Complaints and reports in 2017, food and drug regulatory authorities at all levels accepted 880000 complaints and reports of food (including health food), 31000 filed cases and 31000 closed cases We have handled 58000 drug complaints and reports, filed 4825 cases and closed 4737 cases We have received 15000 complaints and reports of medical devices, 834 filed cases and 828 closed cases We have accepted 31 thousand complaints and reports of cosmetics, put 1105 cases on file, and closed 1213 cases 6、 Investigation and handling of cases in 2017, the food and drug regulatory authorities investigated 257000 food (including health food) cases, with a value of 680 million yuan, a fine of 2.39 billion yuan, and confiscated 160 million yuan of illegal income 1852 households were ordered to stop production and business, 186 licenses were revoked, 568 fakes and sales centers were destroyed, and 2454 judicial organs were transferred In 2017, the food and Drug Administration investigated and dealt with 112000 drug cases, with a value of 330 million yuan, a fine of 400 million yuan, confiscated illegal income of 110 million yuan, banned 1146 unlicensed businesses, destroyed 238 fake manufacturing and sales centers, ordered 1569 businesses to stop production and business, revoked 162 licenses and handed over 1951 judicial organs In 2017, the food and Drug Administration investigated 318 cases of drug packaging materials, with a value of 3.623 million yuan In 2017, the food and Drug Administration investigated and dealt with 17000 medical device cases, with a value of 180 million yuan, a fine of 430 million yuan, confiscated illegal income of 19.911 million yuan, banned 161 unlicensed businesses, destroyed 31 fake manufacturing and sales centers, ordered 98 businesses to stop production and business, 13 licenses to be revoked and 62 to be handed over to the judiciary In 2017, the food and Drug Administration investigated and dealt with a total of 10000 cosmetic cases; the value of the goods was 68.512 million yuan, a fine of 42.947 million yuan, the illegal income of 10.914 million yuan was confiscated, 284 households were ordered to stop production and business, and 24 cases were handed over to the judiciary Note: [1] the data in this report is from the statistical report system of food and drug administration Unless otherwise specified, the data report period is from December 1, 2016 to November 30, 2017 [2] Production license of medical devices: enterprises that produce both class I and class III products are counted as class I and class III production enterprises respectively in statistics, with only one enterprise in total [3] The deadline for application data of formula registration of infant formula milk powder products and application data of formula food for special medical purposes is December 31, 2017