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2016 Annual Statistical Report on Food and Drug Supervision and Administration Published
Date:2017-05-24

On May 23, 2017, CFDA issued the 2016 Annual Statistical Report on Food and Drug Supervision and Administration, which is excerpted as below:

• Drug manufacturing licensing

As of the end of November 2016, China has a total of 4,176 active substance and preparation manufacturers. In 2016, the numbers of pharmaceutical manufacturers, active substance and preparation manufacturers have all decreased, the underlying reason is that: in the manufacturing license renewal period, some enterprises failed to pass the GMP certification, and are thus pending for renewal of certificates.

• Drug distributing licensing

As of the end of November 2016, China has a total of 465,618 enterprises with the Drug Distributing License, of which there are 11,794 corporate wholesale enterprises, 1,181 unincorporated wholesale enterprises; 5,609 retail chain enterprises, 220,703 retail chain stores; and 226,331 retail mono-drugstores.

• Drug registration

In 2016, a total of 4,011 applications for new drug clinical trial have been approved, along with 5 applications for NDA + approval number, and 13 applications for approval number; as well as 328 applications for clinical trial submitted in accordance with new drug application procedures have been approved. In 2016, CFDA approved a total of 2,949 applications for clinical trial of generic drugs, and 207 applications for production. In 2016, CFDA approved a total of 513 applications for clinical trial of imported drugs, and 28 applications for marketing. In 2016, CFDA approved a total of 2,560 drug supplementary applications, and 578 applications for filing. Food and drug regulatory authorities of all provinces (autonomous regions and municipalities) have approved a total of 5,202 drug supplementary applications, and 16,039 applications for filing. In 2016, CFDA approved a total of 782 applications for production of packaging materials and containers in direct contact with drugs, 924 applications for registration renewal, and 280 supplementary applications.

The report data are from the Food and Drug Administration Statistical Reporting System. The data reporting period ranges from December 1, 2015 to November 30, 2016.

 

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