The 2016 Annual Report on Food and Drug Supervision Statistics Has Been Released

I. Production and Operation Licensing Status

(I) Food Production and Operation Licensing Status

1. Food Production Licensing Status

In 2016, provincial (autonomous region, municipality) bureaus issued 18,854 new food production licenses and 462 new food additive production licenses. As of the end of November, there were 165,918 food production licenses and 3,480 food additive production licenses nationwide; there were 136,233 food production enterprises and 3,329 food additive production enterprises.

2. Food Operation Licensing Status

As of the end of November 2016, there were 12,338,782 food operation licenses nationwide, including 8,626,330 for food sales, 3,200,790 for catering services, and 511,662 for unit canteens.

(II) Health Food Production Licensing Status

As of the end of November 2016, there were 2,328 health food production licenses nationwide.

(III) Drug Production and Distribution Licensing Status

1. Drug Production Licensing Status

As of the end of November 2016, there were 4,176 pharmaceutical raw material and finished drug manufacturers nationwide. The number of pharmaceutical manufacturers, as well as the number of raw material and finished drug manufacturers, decreased in 2016. This was because some companies postponed their license renewals due to not having passed GMP certification.

2. Drug Distribution Licensing Status

As of the end of November 2016, there were 465,618 companies holding drug distribution licenses nationwide, including 11,794 legal entity wholesale companies and 1,181 non-legal entity wholesale companies; 5,609 retail chain companies with 220,703 retail chain stores; and 226,331 independent retail pharmacies.

(IV) Medical Device Production and Distribution Licensing Status

1. Medical Device Production Licensing Status

As of the end of November 2016, there were 15,343 medical device manufacturers nationwide, of which 4,979 could produce Class I products, 8,957 could produce Class II products, and 2,366 could produce Class III products.

2. Medical Device Distribution Licensing Status

As of the end of November 2016, there were 335,725 Class II and III medical device distribution companies nationwide, of which 164,634 only distributed Class II medical devices, 62,220 only distributed Class III medical devices, and 108,871 distributed both Class II and Class III medical devices.

(V) Cosmetic Production Licensing Status

As of the end of November 2016, there were 4,798 cosmetic production/hygiene licenses issued to cosmetic manufacturers.

II. Registration and Approval Status

(I) Health Food Registration Status

In 2016, a total of 312 initial registration applications, 738 change applications, 143 technology transfer applications, and 118 re-registration applications for health foods were approved.

(II) Drug Registration Status

In 2016, 4011 new drug clinical trial applications, 5 new drug certificates and approval numbers, and 13 approval numbers were approved in the new drug application process; a total of 328 clinical trial applications submitted according to the new drug application procedure were approved.

In 2016, a total of 2949 generic drug clinical trial applications and 207 production applications were approved.

In 2016, 513 imported drug clinical trial applications and 28 drug marketing authorizations were approved.

In 2016, the State Drug Administration approved 2560 drug supplementary applications and 578 filings. Provincial (autonomous region, municipality) drug administrations across the country approved 5202 drug supplementary applications and 16039 filings.

In 2016, the State Administration for Market Regulation approved 782 applications for the production of packaging materials and containers that directly contact pharmaceuticals, 924 re-registration applications, and 280 supplementary applications.

(III) Medical Device Registration Status

In 2016, a total of 11,539 domestic Class I medical device filings and 3,023 imported Class I medical device filings were approved nationwide; 6,093 domestic Class II registered medical devices and 929 domestic Class III registered medical devices were approved; 444 imported Class II registered medical devices (including those from Hong Kong, Macao, and Taiwan) and 593 imported Class III registered medical devices (including those from Hong Kong, Macao, and Taiwan) were approved. 6,076 domestic Class II medical device renewal registrations and 1,510 domestic Class III medical device renewal registrations were approved; 2,077 imported Class II medical device renewal registrations (including those from Hong Kong, Macao, and Taiwan) and 1,634 imported Class III medical device renewal registrations (including those from Hong Kong, Macao, and Taiwan) were approved. 3,814 domestic Class II medical devices underwent changes to their licensing items, and 1,466 domestic Class III and imported (including Hong Kong, Macao, and Taiwan) medical devices underwent changes to their licensing items. (IV) Cosmetic Registration Status

In 2016, a total of 3,022 initial applications for special-purpose cosmetics were approved, 703 were renewed, and 1,064 were amended; 10,652 initial filings for imported non-special-purpose cosmetics were approved, 1,285 were renewed, and 1,073 were amended.

III. Advertising Approval and Handling Status

In 2016, a total of 30,027 drug advertisements were approved nationwide, of which 19,799 were filed in different locations. 7,067 illegal drug advertisements were transferred to the Administration for Industry and Commerce. 29 drug advertisement approval numbers were revoked.

In 2016, a total of 7,109 medical device advertisements were approved nationwide. 575 illegal medical device advertisements were transferred to the Administration for Industry and Commerce; 20 medical device advertisement approval numbers were revoked.

In 2016, a total of 6,936 health food advertisements were approved nationwide. 627 illegal health food advertisements were transferred to the Administration for Industry and Commerce, and 23 health food advertisement approval numbers were revoked.

IV. Status of Traditional Chinese Medicine Variety Protection

As of the end of November 2016, there were 267 protected traditional Chinese medicine varieties certificates, including 120 newly applied varieties, 15 varieties of the same type, and 132 varieties with extended protection periods.

V. Complaints and Reports

In 2016, food and drug regulatory departments at all levels received 577,915 complaints and reports related to food, filed 22,479 cases, and closed 20,988 cases. They received 26,966 complaints and reports related to health food, filed 640 cases, and closed 705 cases. They received 49,354 complaints and reports related to drugs, filed 4,144 cases, and closed 4,880 cases. They received 11,693 complaints and reports related to medical devices, filed 803 cases, and closed 968 cases. They received 26,542 complaints and reports related to cosmetics, filed 1,152 cases, and closed 1,222 cases.

VI. Case Handling Status

In 2016, food and drug regulatory authorities investigated and handled 171,221 food-related cases, with a total value of 526.209 million yuan, fines of 1,605.709 million yuan, and confiscation of illegal gains of 80.468 million yuan. They investigated and dealt with 7,741 unlicensed businesses, dismantled 344 counterfeit production dens, revoked 146 licenses, and transferred 1,514 cases to judicial organs.

In 2016, food and drug regulatory authorities investigated and handled 3,725 health food cases, with a total value of 78.667 million yuan, fines of 47.864 million yuan, and confiscation of illegal gains of 1.969 million yuan. They shut down (investigated and dealt with) 75 unlicensed production and operation businesses, dismantled 21 counterfeit production and sales dens, ordered 97 businesses to cease production and operation, and transferred 141 cases to judicial organs.

In 2016, food and drug regulatory authorities investigated and handled 96,825 cases related to pharmaceuticals, with a total value of 633.604 million yuan, fines of 458.217 million yuan, and confiscation of illegal gains of 131.755 million yuan. They shut down 1,401 unlicensed businesses, dismantled 188 counterfeit production and sales dens, ordered 1,702 businesses to cease production or operations, revoked 153 licenses, and transferred 1,655 cases to judicial organs.

In 2016, food and drug regulatory authorities investigated and handled 457 cases related to pharmaceutical packaging materials, with a total value of 2.68 million yuan.

In 2016, food and drug regulatory authorities investigated and handled 13,865 cases involving medical devices, with a total value of RMB 81.28 million, fines of RMB 243.34 million, and confiscation of illegal gains of RMB 20.724 million. They shut down 163 unlicensed businesses, destroyed 17 counterfeit production and sales dens, ordered 170 businesses to cease production or operations, revoked 15 licenses, and transferred 67 cases to judicial organs.

In 2016, food and drug regulatory authorities investigated and handled 7,673 cases involving cosmetics, with a total value of RMB 33.478 million, fines of RMB 36.266 million, and confiscation of illegal gains of RMB 9.505 million. They ordered 162 businesses to cease production or operations and transferred 26 cases to judicial organs.

Note: [1] The data in this report comes from the "Statistical Reporting System for Food and Drug Supervision and Management." The data reporting period is from December 1, 2015 to November 30, 2016. [2] Medical device production licensing: Enterprises that produce both Class I and Class III products are counted as Class I and Class III production enterprises respectively in the statistics, and only one such enterprise is counted.

[3] Medical device business licensing: Enterprises that operate both Class II and Class III businesses are counted in their respective categories in the statistics.