This compilation of regulatory terms and definitions is derived from a set of RAPS publications covering the US, EU, Canada and international markets. It includes more than 5,000 definitions from a variety of sources, specifying the region for each, cross-referenced for easy use. Entries were selected based on their relevance to professionals involved in all lifecycle stages for biologics, medicinal products, medical devices and related healthcare products.

This resource is intended for regulatory professionals, developed by regulatory professionals, and RAPS members are encouraged to share input, make additions, or otherwise provide clarity where it might benefit fellow regulatory pros.

Members who are logged in may submit proposed changes up to a maximum of 500 characters. Submissions will be vetted by RAPS editorial review team, and notification of approval or denial will be made within 48 business hours.
 
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