Skip to main content

Information on Regulatory Writing


Clinical courses


Clinical research courses

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 Marketing Authorizations. These documents follow very specific and rigid formats.

Regulatory writers mustbe adept at working with data management and clinical operations groups to review and interpret clinical trial data. Writers also require a keen knowledge and understanding of the drug-development process, FDA regulatory requirements, Good Clinical Practice (GCP), Good Publication Practice (GPP), and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, including strong familiarity with the eCTD (electronic common technical document, used now by most companies to submit documents). Attention to detail is a must, since regulatory writers work with enormous amounts of data that require accurate reporting.

This article in provided by, Indegene India