《THE INTERNATIONAL REGULATION OF PHARMACEUTICAL DRUGS》

International Regulation of Pharmaceutical Drugs1

Pharmaceutical Drugs—The International Dimension23

Control of Quality， Safety and Efficacy of Drugs Entering International Commerce34

Regional Quality Control Efforts38

Good Manufacturing Practices41

Certification of the Quality of Pharmaceutical Products5

Monitoring of Adverse Reactions to Drugs47

Drug Information53

International Pharmacopoeia54

Technical Information55

Drug Regulation59

The United States and the International Regulation of Pharmaceutical Drugs63

Tables2

Ⅰ： Export Trade in Pharmaceuticals2

Ⅱ：Major Characteristics of National Drug Regu-lations in Five Selected Countries8

Ⅲ： Twenty Largest International Pharmaceutical Companies， 197225

Ⅳ： World Production of Pharmaceutical Products26

Ⅴ： Generic Name and Origin of the 138 Major Pharmaceutical Innovations 1950—196727

Ⅵ： International Governmental and Non-govern- mental Organizations Concerned with the Pharmaceutical Regulations33

Ⅶ： Comparison of Prices （in EEC units of ac-count） of a Selection of Pharmaceutical Products on Sale in Six EEC States， 197270

Ⅷ： Comparison of Prices According to Nationality of Parent Company of Manufacturer71

Charts3

Ⅰ：Trade Balance in Pharmaceuticals by World Re-gions3

Ⅱ： Five Stage Progression of the Regulatory Proc-ess in the Development， Testing and Manu-facture of Pharmaceuticals20

Appendices74

Ⅰ：Good Practices in the Manufacture and Quality Control of Drugs74

Ⅱ： Certification Scheme on the Quality of Pharma-ceutical Products Moving in International Commerce92

Ⅲ： World Health Organization Resolutions Con-cerning Quality Control in Pharmaceuticals98