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1999年 6月 ,我国《处方药与非处方药分类管理办法》(试行 )正式公布 ,并决定自 2 0 0 0年 1月 1日起实行处方药与非处方药分类管理制度。 1999年 6月国家药品监督管理局公布了第一批国家非处方药药品目录 ,共计 32 5个品种 ,其中化学药品 16 5个 ,中成药 16 0个 (刊登在本刊1999年第 6期第 4 6 2～ 4 6 5页 )。 2 0 0 1年 6月 ,国家药品监督管理局公布了第二批国家非处方药药品目录 ,该目录包括 1535个药品制剂 ,其中化学药品制剂 2 0 5个 (含乙类非处方药 6 9个 ) ,中成药制剂 1330个 (含乙类非处方药 352个 ) (分别刊登在本刊 2 0 0 1年第 7期第 4 6 4～ 4 71页和 2 0 0 1年第 8期第 537～ 54 3页 )。此外 ,从第一批国家非处方药药品目录中 ,经专家临床评价后进一步遴选出乙类非处方药 194个 ,其中化学药品制剂 88个 ,中成药制剂 10 6个 (刊登在本刊 2 0 0 1年第 10期第 6 71页 )。 2 0 0 2年 9月 10日和 2 0 0 2年 11月 6日 ,国家药品监督管理局分别公布了第三批国家非处方药药品目录共计 6 15个药品制剂 ,其中化学药品制剂 97个 ,中成药制剂 518个。 2 0 0 2年 11月 2 8日国家药品监督管理局公布了第四批国家非处方药药品目录 (一 ) ,共计 30 3个药品制剂 ,其中化学药品制剂 10 7个 ,中成药制剂 19
In June 1999, China’s “Regulations on the Classification and Administration of Prescription Drugs and Non-prescription Drugs” (Trial Implementation) was officially announced and it was decided that the classification management system for prescription drugs and non-prescription drugs should be implemented from January 1, 2000. In June 1999, the State Drug Administration announced the first batch of national non-prescription drug catalogs, totaling 325 varieties, including 165 chemical products and 160 proprietary Chinese medicines (published in the journal No. 6 of 1999, No. 46 2 ~ 4 6 5 pages). In June 2001, the State Drug Administration announced the second batch of national non-prescription drugs catalogs, which included 1535 pharmaceutical preparations, of which 205 were chemical preparations (69 including Category B over-the-counter drugs) 1,330 medicinal preparations (including 352 non-prescription B drugs) (published separately in Issue 7, Issue 04, pp. 464-71, 2001 and Issue 8, pages 537-53, 2001) . In addition, from the first batch of national over-the-counter drug catalogs, a total of 194 B-type non-prescription drugs were further selected through clinical evaluation by experts, of which 88 were pharmaceutical preparations and 106 were proprietary Chinese medicines (published in 2001 10, p. 6 71). On September 10, 2002 and November 6, 2002, the State Drug Administration released the third batch of national non-prescription drug product catalogs respectively for a total of 615 pharmaceutical preparations, of which 97 were chemical preparations 518 medicine preparations. On November 28, 2002, the State Drug Administration released the fourth batch of national non-prescription drugs catalogs (1) for a total of 30 3 pharmaceutical preparations, of which 107 were chemical preparations, 19 for proprietary Chinese medicines