In a blink, it comes to the end of another year! 2017 is being further away. Do you know what are the new Chinese-produced drugs approved for production in this year, as a pharmaceutical practitioner?

Chinese-produced new chemical drugs with 16 acceptance numbers approved for production

Looking back the drug registration application situation of China in 2017, chemical drugs still dominate the drug registration application field in China. According to statistics, by December 21, the quantity of acceptance numbers of chemical drugs undertaken by CDA was 3,696 in total and there were 191 acceptance numbers of chemical drugs approved for production.

CFDA introduced the reform plan for chemical drug registration classification in March 2016. The new measures for administration are stricter with the definition of new drugs, compared to the previous measures for administration of classified applications of pharmaceutical product registration in 2007. According to the new measures for administration of registration, "For the pharmaceutical products under Class 1 and 2 of new registration classification, application shall be submitted in accordance with the procedure for new drugs in the Measures for the Administration of Drug Registration; for the pharmaceutical products under Class 3 and 4 of new registration classification, application shall be submitted in accordance with the procedure for generic drugs in the Measures for the Administration of Drug Registration."

According to statistics, after issuance of the new edition of the Measures for the Administration of Drug Registration, there were 272 acceptance numbers of Class 1 new chemical drugs approved for clinical trial by December 21, 2017, and there is no Class 1 new chemical drug approved for production for now. The article Another Good News! Outburst of HEC Pharm: Approved for Clinical Trials of 4 Class 1 New Chemical Drug Varieties of the official account of CPhI can be referred to for relevant information.

However, according to the measures for administration of classified applications of pharmaceutical product registration in 2007, among the Chinese-produced new chemical drugs applied for previously, there were 16 acceptance numbers of drugs approved for production in 2017, covering 7 APIs, and including 1 registration application of Class 3.4 new drug, and 15 registration applications of Class 3.1 new drugs. See the following table for the details.

Wherein, among the 7 APIs, there were 3 manufacturers approved to produce tenofovir disoproxil fumarate, and separately 1 manufacturer approved to produce other APIs.

Categories of new drugs approved

Among those approved for production, the category of drugs with the most acceptance numbers is nucleoside/nucleotide reverse transcriptase inhibitors, having 5 acceptance numbers, followed by immunosuppressive agents and sympathomimetic drugs, separately having 4 and 3 acceptance numbers, and the remaining categories include fluoroquinolones, coxibs, antineoplastic drugs, and gynecological drugs, separately having one acceptance number only.

Dosage form distribution

Among the 16 acceptance numbers of new chemical drugs approved for production, 9 are for API and intermediate preparation, 6 are for ordinary capsules, and 1 is for ordinary tablets.

Approval period

From the perspective of distribution of undertaking time of CDE, the quantity of acceptance numbers with the registration application filed in 2012 and beyond accounts for 14, wherein, the variety earliest undertaken by CDE is Pazufloxacin Mesilate of Fujian Sanai Pharmaceutical Co., Ltd.: this chemical drug with acceptance No. of CXHS0600402 was filed application in April 2006, and approved for production in August 2017, taking 130 months; the variety latest undertaken is Lenalidomide of SL Pharmaceutical, including acceptance numbers of CXHS1400266, CXHS1400267, and CXHS1400268, with the application started in January 2015, and the time of approval for production being November 2017, taking 34 months; the average review time of the 16 acceptance numbers of drugs approved for production is 55 months.

Those included in the priority review and approval procedure among the above 16 acceptance numbers of new chemical drugs approved for production include: the lenalidomide ordinary capsules and API and intermediate preparation of SL Pharmaceutical, tenofovir disoproxil fumarate capsules and API of Fujian Cosunter, parecoxib sodium of Sichuan Kelun Pharmaceutical, bortezomib API of Lianyungang Hongchuang Pharmaceutical, and tenofovir disoproxil fumarate API of Lianyungang Runzhong Pharmaceutical.

Note: The month calculation method is as follows: 15 days and more calculated as one month, less than 15 days not calculated.