FDA vs. EMEA and MHRA
Activities of the FDA are much broader than activities of the EMEA and the MHRA in that it focuses on protection of health in general and regulates food, drugs, medical devices, biologics, animal feed and drugs, cosmetics and also radiation-emitting products and tobacco.
Within these areas, however, its roles are similar to the EMEA and the MHRA. The FDA assesses new products, approves their marketing and operates post-marketing surveillance.
In addition, the FDA under the authority of the courts has an executive power and can directly sanction with the courts authority non-compliance with GMP standards or violation of other types of pharmaceutical regulation.
cGMP
The FDA uses the term “current GMP” (cGMP) to emphasize that manufacturers have to employ up-to-date technologies and systems in order to comply with the regulations.
The FDA’s cGMPs incorporate the ICH Q7A guidance for active pharmaceutical ingredients.
