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Regulatory Writing Regulatory writing is a highly scientific
niche that involves the production of documentation required for
the approval of drugs by regulatory authorities. The documents
are created based on specific templates and guidelines that
report the results of clinical trials and are ultimately
submitted to the US Food and Drug Administration (FDA). Other
national agencies include Health Canada (Canada), European
Medicines Agency (EMA) (European Union), and the Ministry of
Health, Labour and Welfare (Japan). Such agencies assess the
efficacy and safety of drugs throughout the clinical trials
process and ultimately approve their use in a specified patient
population. Regulatory writers are expected to work on a whole
range of documents such as Investigator’s Brochures, Clinical
Protocols, Patient Information Sheets, Investigational New Drug
Applications, New Drug Applications, Clinical Study Reports,
Common Technical Documents, and Marketin