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
glossary
Orphan Drug Designation (ODD)
Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or…
glossary
New Chemical Entity (NCE)
A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products. New Chemical…
glossary
Market Exclusivity
The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be…
glossary
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…
glossary
Anonymization Report (AR)
Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical…
glossary
Anonymization
The process of rendering data into a form which does not identify individuals and where identification is not likely to…
glossary
Innovation Meeting
Innovation meetings are held by major EU Member States Competent Authorities (CA) to help organizations that are developing innovative medical…
glossary
Informed Consent Form (ICF)
Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical…
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