The Food and Drug Administration is a federal agency within the United States. They are responsible for protecting and promoting public health through the regulation and supervision of OTCs, medicines and biologics among other things. This website contains valuable information for the industry on regulations, approvals, warning letters, and guidance documents.
MHRA is the premier source for drug safety and other information in the United Kingdom.
The EMA is responsible for the protecting and testing of various medicines and drugs that are implemented throughout Europe.
These other resources below are also very useful and important to help you gain the knowledge that you need! Please take the time read through the PDFs below and expand your knowledge.
[gdlr_button href=”http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf” target=”_blank” size=”small” background=”#8cc63f” color=”#ffffff”]21 CFR Part 11[/gdlr_button] [gdlr_button href=”http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf” target=”_blank” size=”small” background=”#f21a7f” color=”#ffffff”]ICH E6 [/gdlr_button]