Every country has an agency that decides whether drugs can be sold. These regulatory authorities review applications, inspect manufacturing facilities, monitor safety after approval, and take action when problems arise. The FDA in the United States, the EMA in the European Union, and the MHRA in the United Kingdom are among the most influential. Others include Health Canada, the Therapeutic Goods Administration in Australia, and the Pharmaceuticals and Medical Devices Agency in Japan.

Regulatory authorities vary in size, resources, and procedures, but they share common goals: ensuring that drugs are safe, effective, and of high quality. They review preclinical and clinical data, assess the risk-benefit balance, and approve or reject applications. They also oversee labeling, advertising, and post-marketing surveillance. International harmonization efforts, led by the International Council for Harmonisation, have aligned many technical requirements, but each authority retains its own decision-making power. A drug approved in one country is not automatically approved in another.

Core functions:

• Review. Assessing applications for safety and efficacy.
• Inspection. Checking manufacturing facilities for compliance.
• Surveillance. Monitoring adverse events after approval.
• Enforcement. Recalls, warning letters, and market withdrawal.
• Guidance. Publishing standards and expectations for industry.

Regulatory decisions are public in many countries, and the documents behind them are often available online.