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Annual report on the administration of food and drugs in 2016

  • Author:Jane
  • Source:Cfda
  • Release on :2017-05-25


First, the production and functioning of the licence

(1) Food production and business licence

1. Food production licence

In 2016 the provinces (autonomous regions and Municipalities) Bureau issued a total of 18,854 new food production licence, food additives production Licence 462. From the end of November, the country a total of 165918 food production licence, food additives production Licence 3480; A total of 136233 food production companies, food additives production companies 3329.

2. Food Business License

From the end of November 2016, the country a total of 12338782 food business licence, of which 86,263,303 food sales, catering services 32, 00790, 511662 canteen units.

(2) Healthy food production licence

From the end of November 2016, the country has a total of 2328 healthy food production licence.

(3) Drug production and business licence

1. Drug-producing licence

From the end of November 2016, the country a total of 4176 raw materials and pharmaceutical production companies. In 2016, the number of production pharmaceutical companies and the number of raw materials and pharmaceutical companies have decreased, i.e. the period of renewal of the production company licence, some companies have not passed GMP certification, have temporarily the conditions for renovation of the replacement.

2. Drug Business License

From the end of November 2016, the country has a total of 465618 licensed companies for the pharmaceutical business licence, of which 11,794 legal entity wholesale companies, 1181 illegal wholesale companies; Retail chain companies 5609, retail chain stores 220703; Retail only pharmacy 226331 family.

(4) Medical equipment production and business licence

1. Medical Device Production licence

From the end of November 2016, the country has 15,343 manufacturing companies of medical devices, of which: can produce a class of products 4979 companies, can produce two types of products 8957 companies, can produce three types of products 2366 companies.

2. Medical Device Business License

From the end of November 2016, the country has two or three types of medical equipment business companies 335725, of which only two types of business medical equipment companies 164634, only three types of business medical equipment companies 62220, while engaged in two classes of business medical equipment companies 108871 home.

(5) Cosmetic production licence

From the end of November 2016, a total of 4798 parts of cosmetic production companies/health licenses.

Second, the status of examination of registration and approval

The Health Food Register

In 2016, a total of 312 initial registration applications for healthy foods were approved, 738 were altered, 143 for technology transfer and 118 to re-record.

(b) the registration of drugs

2016 in the new medication approval work approved the new drug clinic 4011, new drug certificate and approval number 5, approval number 13; Approved by the new Medicines application procedures to declare clinical applications 328.

In 2016, 2949 clinical applications were approved for generic medications and 207 were produced.

2016 approved a total of 513 imported drug cases, listed 28.

2016 General Administration approved a total of 2560 drug application, for the registry 578. The provinces (autonomous regions and Municipalities) Bureau approved a total of 5202 drug enforcement, for the record 16039.

In 2016, the General administration approved a total of 782 applications for direct contact with packaging materials and pharmaceutical containers, 924 applications for re-enrollment and 280 additional applications.

(c) The registration of medical devices

In 2016, the country approved a total of the territory of the first class of medical equipment for the registration 11539, the first category of imports of medical equipment for the registry 3023; The second category of registered medical equipment 6093, the territory of the third category of registered medical equipment 929, registered medical equipment (including Hong Kong, Macau and Taiwan) 444, import the third category of registered medical equipment (including Hong Kong, Macau and Taiwan) 593. Approved the second category of continuation of registered medical equipment 6076, the third category territory continued to register medical equipment 1510, the second category of medical equipment imports (including Hong Kong, Macau and Taiwan) 2077, importing the third category of registered medical equipment (including Hong Kong and Macau Taiwan) 1634 parts. The territory of the second type of licensing subjects to change the medical equipment 3814, the territory of the third category and import (including Hong Kong, Macau and Taiwan) licensing issues to change the medical equipment 1466.

(d) The Cosmetic register

2016 approved a special request for cosmetics for the first time to declare 3022, the continuation of 703, change 1064; Non-special use approved cosmetics imported for the first time 10,652, continuation 1285, change 1073.

Third, the approval of publicity and investigation of the situation

In 2016, the country approved a total of 30027 pharmaceutical advertising parts, of which 19799 copies of the record for different places. 7067 cases of illegal drug propaganda have been transferred to the administrative department of Industry and Commerce. Suspension of drug approval number 29.

In 2016, the country approved a total of 7109 medical devices for advertising, industrial and commercial administrative departments to transfer the illegal medical device from advertising 575; Revocation of medical Equipment approval announcement number 20.

In 2016, the country approved a total of 6936 health food advertising, industrial and commercial administrative departments to transfer illegal foods advertising 627, to recover the health of advertising food approval number 23.

Room, protection of traditional Chinese medicine varieties

From the end of November 2016, a total of 267 varieties of traditional Chinese medicine to protect varieties, of which 120 varieties of the first declaration, with the same species 15, extended protection period of 132.

5, Complaints reported

2016 at all levels of food and drug regulation departments received a total of 577915 complaints of food complaints, 22479 cases, closed 20988 cases. Receipt of healthy food complaints 26966 cases, 640 cases, 705 cases closed. Accept drug complaints reported 49,354 cases, 4144 cases, 4880 closed cases. Complaints received from medical equipment reported 11693, 803 cases, 968 closed cases. Complaints received complaints 26542 complaints, 1152 cases, closed 1222 cases.

Six cases investigated and treated with

2016 the food regulatory departments and medicines were investigated and treated with 17,121 food cases, the amount of 52,620,900,000 yuan, a fine of 1,605,709,000 yuan, the amount of illegal income of 80,468,000 yuan confiscated, investigated and treated with 7741 undocumented, 344 false dens, parts, transferred to the judiciary 1514 parts.

2016 the departments of Food and drug supervision were investigated and treated with 3725 cases of healthy foods, the amount of 78,667,000 yuan, a fine of 47,860,000 yuan, the amount of illegal income of 1,969,000 yuan, banned (investigating and dealing) without permission to produce 75 families, false Nest 21, ordered to suspend production 97, transferred to the judiciary 141.

2016 the departments of Food and drug supervision were investigated and treated with 96825 drug cases, the amount of 633,604,000 yuan, a fine of 458,217,000 yuan, confiscate the amount of illegal income of 131,755,000 yuan, to prohibit 1401 unlicensed businesses, cut the sale of 1702, revoked licence 153, transferred to the judiciary 1655 parts.

2016 the Food and drug regulatory departments have been investigated drug-packing materials 457 cases, the value of the quantity of 2,680,000 yuan.

2016 the departments for the supervision of food and drugs were investigated and treated with 13865 cases of medical equipment, the value of 81,280,000 yuan, the amount of 243,340,000 yuan fined, confiscate the amount of illegal income of 20,724,000 yuan, to prohibit 163 business licence, ordered to stop the production and closure of 170 families, the repeal of 15 licenses, transferred to the judiciary 67.

2016 the Food and drug supervision departments were investigated and treated with 7673 cosmetic cases, the value of 33,487,000 yuan, a fine of 36,226,000 yuan, the amount of illegal income of 950,500,000 yuan, ordered to suspend business for 162 families, transferred to the judiciary 26.

Note: [1] The report data for "Food and drug supervision and management of the statistical information system". The data is reported from 1 December 2015 to 30 November 2016.

[2] licence for production of medical equipment: both the production of a product class and the production of three types of business products, the statistics were counted as a class of production companies and three types of production companies, the total number of companies only one.

[3] Medical Device business License: At the same time operating two categories and three types of companies in the statistics were included in their respective categories.