While learning regulatory affairs there are several abbreviations you come across, you usually end up searching for them. Here is a list of abbreviations that are commonly repeated. There are several topics related to regulatory affairs where you come across these

List of common abbreviations in regulatory affairs

AP – Applicant’s Part
RP – Restricted Part
OP – Open Part
CP – Closed Part
NME – New Molecular Entity
NCE – New Chemical Entity
SmPC – Summary of Product Characteristics
PL – Packaging Leaflet
RMS – Reference Member State
CMS – Concerned Member State
CHMP – The Committee for Medicinal Products for Human Use
CPMP – Committee for Proprietary Medicinal Products
CVMP – Committee for Medicinal Products for Veterinary Use
SUPAC – Scale-up and post approval change

BACPAC – Bulk Active Chemicals Post Approval Changes
cGMP – Current good Manufacturing Practice

GCP- Good clinical Practice
GLP – Good Laboratory Practice

NDA – New Drug Application
ANDA – Abbreviated New Drug application
IND -Investigational New Drug Application
DMF -Drug Master file
ASMF- Active Substance Master File
MAA -Marketing Authorization Application
CEP -Certificate of Suitability to the monographs of the European Pharmacopoeia
ICH- The International Conference on Harmonization of technical requirements for registration of Pharmaceuticals for human use.
CTD -Common technical document for the registration of pharmaceuticals for human use.

These are some of the abbreviations in regulatory affairs .