Global Pharmaceutical Regulation Timeline

Pharmaceutical companies have faced the challenge of complying with government regulations for more than 170 years, and the requirements continue to evolve and multiply year after year.Federal regulation of pharmaceutical drugs emerged as early as 1848 in the United States, under a law that addressed only imported drugs.

Then came the Pure Food and Drug Act of 1906, which prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid the foundation for the nation’s first consumer protection agency, the Food and Drug Administration (FDA).

In 1938, Congress passed the Federal Food, Drug and Cosmetic Act with new provisions. For the first time, manufactures were required to show that a drug was safe before it could be marketed.

In 1966, the Fair Packaging and Labeling Act required all consumer products in interstate commerce to be honestly and informatively labeled, with the FDA enforcing provisions on food, drugs, cosmetics and medical devices.

In 1982, the FDA issued tamper-evident packaging requirements, and the Federal Anti-Tampering Act, passed in 1983, made it a crime to tamper with packaged consumer products.

The global framework for pharmaceutical regulations has undergone a profound transformation in the past two decades.

Timelines for serialization compliance are often extremely challenging, especially with changing requirements and multiple mandates occurring simultaneously.

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PHARMACEUTICAL REGULATION

TIMELINE 2010-2023

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