Governance, Risk, and Compliance Handbook: Technology, Finance, Environmental, and International Guidance and Best Practices

CHAPTER 35

PHARMACEUTICAL

James G. Robertson

35.1 INTERNATIONAL

35.2 CANADA

35.3 EUROPE

35.4 ASIA

(a) China

(b) Japan

(c) Hong Kong

35.5 SUMMARY

NOTES

Manufacturing, research, design, development, marketing, and many operations in the pharmaceutical industry have been regulated in the United States since 1906 when the U.S. Food and Drug Administration (FDA) was created by passage of the Food and Drugs Act. This act has been amended significantly 19 times, is supplemented by 23 other acts, and is now known as the Federal Food, Drug, and Cosmetic Act. Under the authority created by these acts, the FDA has made over 1,000 rules in Title 21 of the Code of Federal Regulations (CFR). The FDA mission statement asserts that the FDA "is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation." This scope of regulation is very broad, and together it encompasses around a quarter of the U.S. economy.

Similar regulations are in place in other developed countries and regions, including Canada, Europe, Australia, and Japan. Emerging economies typically rely on regulations from the World Heath Organization (WHO).1 These align reasonably well with those from the United States and other developed countries. Europe and some other countries also require registration of manufacturers for compliance with certain ISO standards. ...