QA104 FDA, Health Canada, European and International Regulatory Agencies and Structures

Each country across the globe has in place a national competent authority, such as FDA, Health Canada and EMA, that is responsible for setting pharmaceutical standards, monitoring compliance, and enforcing regulations.

Some of regulatory bodies, such as WHO and ICH have the power to set global standards and contribute in regulatory harmonization.

This course outlines the structure and function of U.S. and other regulatory bodies and agencies around the globe. The course, also, discusses the various agencies relationship and authorities as well as the current regulatory harmonization status.

Learning points:

• FDA structure and organization
• Health Canada structure and organization
• EMA structure and organization
• Regulatory bodies in Latin America, Asia-Pacific Region, Middle East and Africa.
• Role of ICH, WHO and other global regulatory bodies
• Global Harmonization