ADME |
Absorption, Distribution, Metabolism and Excretion
|
ASR |
Annual Safety Report |
BLA |
Biological License Application |
| CEP |
Certificate of European Pharmacopeia
(certificate of suitability) |
| CMC |
Chemical, Manufacture and Control |
| CP |
Centralised Procedure |
| CPP |
Certificate of Pharmaceutical Product |
| CTA |
Clinical Trial Application |
CTD |
Common Technical Document |
| CRO |
Contract Research Organisation |
| DCP |
Decentralised Procedure |
| DMF |
Drug Master File |
eCTD |
Electronic Common Technical Document |
ERA |
Environmental Risk Assessment |
| EU |
European Union |
| GCP |
Good Clinical Practice |
| GLP |
Good Laboratory Practice |
| GMP |
Good Manufacturing Practice |
| ICH |
International Conference on Harmonisation |
| IMPD |
Investigational Medicinal Product Dossier
|
| IND |
Investigational New Drug |
| MA |
Marketing Authorisation |
| MAA |
Marketing Authorisation Application |
| MRP |
Mutual Recognition Procedure |
| NDA |
New Drug Application |
| ODD |
Orphan Drug Designation |
| OTC |
Over-The-Counter |
PIL |
Patient Information Leaflet |
| PIP |
Paediatric Investigation Plan |
| PSUR |
Periodic Safety Update Report |
PD |
Pharmacodynamy |
PK |
Pharmacokinetic |
PL |
Package Leaflet |
| PUMA |
Paediatric Use Marketing Authorisation |
| RMP |
Risk Management Plan |
| QOS |
Quality Overall Summary |
QRD |
Quality Review of Documents |
| R & D |
Research and Development |
| RMP |
Risk Management Plan |
| SPC |
Summary of Product Characteristics |
| TSE |
Transmissible Spongiform Encephalopathy |
| VAMF |
Vaccine Antigen Master File |
