CFDA Bulletin - Over-repeated Drug Alert Information

CFDA Bulletin - Over-repeated Drug Alert Information

Guidance: CFDA reminds relevant drug manufacturers and R&D institutions to fully understand the market supply and demand situation, scientifically assess drug R&D risks, and make prudent investment business decisions. Relevant departments at all levels must strengthen the examination and acceptance of relevant drug registration applications, on-site inspections and production site inspections, and conduct propaganda work on over-repeated drug varieties that have already been announced, and guide enterprises to rationalize R&D and application.

CFDA Bulletin - Over-repeated Drug Alert Information

The monitoring statistics of drugs covered the chemical and biological products approved by the CFDA before November 25th, 2014, a total of 2,750 generic products (excluding raw materials, vaccines, and in vitro diagnostic reagents for Chinese medicines, non-prescription drugs, involving existing registrations There are about 110,000 approved product numbers; a total of 14 major categories and 99 subcategories involving drug anatomy, therapeutics, and chemical taxonomy (ATC) classifications, of which 3 years are in the CMEI and RDM databases. There are 438 varieties that have no sales records.

The CFDA issued an announcement on over-repeated drug prompt information and sorted out the situation of listed drugs from 2012 to 2014. According to the number of approved companies, the number of companies with more than 20 approved documents and the number of companies with sales approval numbers exceeding 20 were the screening criteria. 282 over-repeated varieties were screened (in common name). Through the analysis of the sample hospital's use of drug sales in the past three years, there are currently 2241 varieties in normal circulation, of which 21 products have more than 100 production companies listed on the market, and 50 varieties have 50-99 production products listed on the market. Circulation. Explain that there are serious problems of over-repetition in some drugs that are normally used in circulation.

Through the analysis of data on sales and usage of the same type in the sample hospital for the first three years in the top 10 (when less than 10 total statistics), the sales of the top 10 varieties, the total sales of more than the total sales amount of the product 90 There were 2088% of the total (93.17% of the total); the use of the top 10 varieties had a total of 2,052 products (91.57% of the total) whose usage exceeded 90% of the total usage of this product. Explain that there are 10 companies in the same category that can meet the market demand.

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