Acronyms

If you feel lost with the acronyms used on this site (or in the Regulatory Affairs world in general), have a look here under. You'll find some of the most frequently used combinations and their meaning.

This page will be regularly updated, so come back to it to check if some new entries popped up since your last visit.

• API : Active Pharmaceutical Ingredient

• BCS : Biopharmaceutics Classification System (FDA)

• BDTF : Big Data Task Force (EMA)

• CAP : Centrally Authorised Medicinal Products (EMA)

• CDMS : Centralised Data Management System

• CESSP : Common European Single Submission Portal (EMA)

• DADI : Digital Application Dataset Integration (EMA)

• eAF : Electronic Application Forms (EMA)

• eCTD : Electronic Common Technical Document (ICH)

• EMA : European Medicines Agency

• ePI : Electronic Product Information (EMA)

• ESG : Electronic Submissions Gateway (FDA)

• ESTRI : Electronic Standards for the Transfer of Regulatory Information (ICH)

• EUDAMED : European Database on Medical Devices (EMA)

• FDA : Food and Drug Administration

• FHIR : Fast Healthcare Interoperability Resources

• ICH : International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

• IDMP : Identification of Medicinal Products (ICH)

• MDR : Medical Device Regulation

• MRP : Mutually Recognised Medicinal Products (EMA)

• NAP : Nationally Authorised Medicinal Products (EMA)

• NCA : National Competent Authority (EMA)

• OMS : Organisations Management Service (EMA)

• PMS : Product Management Service (EMA)

• RMS : Referentials Management Service (EMA)

• SIAMED : EMA database for Centrally Approved Products

• SMS : Substances Management Service (EMA)

• SPOR : Substance, Product, Organisations and Referentials (EMA)

• SSF : Specification for Submission Format

• UUID : (Universally Unique Identifier) Identifies the instances submitted by eCTD v4.0

• xEVMPD : Extended EudraVigilance medicinal product dictionary (Article 57) (EMA)