THE INTERNATIONAL REGULATION OF PHARMACEUTICAL DRUGSPDF电子书下载

International Regulation of Pharmaceutical Drugs 1

Pharmaceutical Drugs—The International Dimension 23

Control of Quality， Safety and Efficacy of Drugs Entering International Commerce 34

Regional Quality Control Efforts 38

Good Manufacturing Practices 41

Certification of the Quality of Pharmaceutical Products 5

Monitoring of Adverse Reactions to Drugs 47

Drug Information 53

International Pharmacopoeia 54

Technical Information 55

Drug Regulation 59

The United States and the International Regulation of Pharmaceutical Drugs 63

Tables 2

Ⅰ： Export Trade in Pharmaceuticals 2

Ⅱ： Major Characteristics of National Drug Regu-lations in Five Selected Countries 8

Ⅲ： Twenty Largest International Pharmaceutical Companies， 1972 25

Ⅳ： World Production of Pharmaceutical Products 26

Ⅴ： Generic Name and Origin of the 138 Major Pharmaceutical Innovations 1950—1967 27

Ⅵ： International Governmental and Non-govern- mental Organizations Concerned with the Pharmaceutical Regulations 33

Ⅶ： Comparison of Prices （in EEC units of ac-count） of a Selection of Pharmaceutical Products on Sale in Six EEC States， 1972 70

Ⅷ： Comparison of Prices According to Nationality of Parent Company of Manufacturer 71

Charts 3

Ⅰ： Trade Balance in Pharmaceuticals by World Re-gions 3

Ⅱ： Five Stage Progression of the Regulatory Proc-ess in the Development， Testing and Manu-facture of Pharmaceuticals 20

Appendices 74

Ⅰ： Good Practices in the Manufacture and Quality Control of Drugs 74

Ⅱ： Certification Scheme on the Quality of Pharma-ceutical Products Moving in International Commerce 92

Ⅲ： World Health Organization Resolutions Con-cerning Quality Control in Pharmaceuticals 98