The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
Qualified Person for PharmacoVigilance (QPPV)
Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market. Qualified Person for PharmacoVigilance A…
Paediatric Investigation Plan (PIP)
A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies…
Orphan Drug Designation (ODD)
Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or…
New Chemical Entity (NCE)
A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products. New Chemical…
Market Exclusivity
The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be…
Applicant for Clinical Trial Applications (CTA)
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees. Applicant for a CTA An applicant…
Anonymization Report (AR)
Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical…
Anonymization
The process of rendering data into a form which does not identify individuals and where identification is not likely to…