The Basics (for People New to Regulatory Affairs)
Resources to build your understanding of the regulatory requirements for drug development.
RAVEN Resource: List of Guidelines, Newsletters and Membership Opportunities
This RAVEN page will provide a listing of available resources for finding information and establishing alerts and email notifications for new regulatory information. (A MUST for regulatory affairs professionals!)
These are the laws which regulate drug development in the United States. While Guidances provide "FDA's current thinking", these are the laws which must be followed in order to maintain compliance.
FDA Website: "The Drug Development Process"
Simple overview of the steps required for a drug to move through the process from preclinical to clinical and then to approval.
An FDA Website that provides Guidance documents, Forms, and Reference information related to all electronic submissions in the US.
FDA Website: Forms and Instructions
FDA website listing forms and instructions for US INDs.
EMA Guidebook: User guide for micro, small and medium-sized enterprises (2016)
is guide has been prepared for micro, small and medium-sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stages of developing a medicinal product. An overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (‘EU’) is provided. The regulatory procedures in place to optimise development and obtain an EU marketing authorisation are also summarised.
ICH Guideline: E8(R1) General Considerations for Clinical Studies (New 2022)
This guidance describes internationally accepted principles and practices in the design and conduct of clinical studies of drug and biological products. The guidance is intended to assist sponsors and other parties that design clinical studies, and to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility. This guidance revises the ICH guidance E8 General Considerations for Clinical Trials issued in December 1997. Significant changes from the 1997 version include the following: (1) addresses study quality to ensure the protection of study participants and the generation of reliable and meaningful results, while promoting study efficiency; (2) addresses a broad range of study designs and data sources; and (3) provides updated cross-referencing to other relevant ICH guidances that inform the design, planning, and conduct of clinical research.
The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.
The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States.
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