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Full forms of some of the Abbreviations related to Regulatory Affairs

  • Author: CEO
  • Create Time: 04/02/2013 17:25:18
  • Last Update Time: 05/02/2013 10:41:37

S.No.

Abbreviation

Full Form

1

NDA

New Drug Application

2

ANDA

Abbreviated New Drug application

3

IND

 Investigational New Drug Application

4

DMF

Drug Master file

5

ASMF

Active Substance Master File

6

MAA

Marketing Authorisation Application

7

CEP

Certificate of Suitability to the monographs of the European Pharmacopoeia

8

ICH

The International Conference on Harmonisation of technical requirements for registration of Pharmaceuticals for human use.

9

CTD

Common technical document for the registration of pharmaceuticals for human use.

10

AP

Applicant’s Part

11

RP

Restricted Part

12

OP

Open Part

13

CP

Closed Part

14

NME

New Molecular Entity

15

NCE

New Chemical Entity

16

SmPC

Summary of Product Characteristics

17

PL

Packaging Leaflet

18

RMS

Reference Member State

19

CMS

Concerned Member State

20

CHMP

The Committee for Medicinal Products for Human Use

21

CPMP

Committee for Proprietary Medicinal Products

22

CVMP

Committee For Medicinal Products For Veterinary Use

23

SUPAC

Scale-up and post approval changes

24

BACPAC

Bulk Active Chemicals Post approval Changes

25

cGMP

Current good Manufacturing Practice

26

GCP

Good clinical Practice

27

GLP

Good Laboratory Practice


Key features of KPE – Advance Diploma in Regulatory Affairs:

Practical Orientation 
Printed/Printable study material 
Access the E-Modules online with user id and password
Online lectures with live interactions with faculty
Access to case study file online
All e-study material contains self assessment computer based test.
Flexible online final examination
Placement assistance provided
The Internationally Accredited course – Approved by International Association of Distance Learning (IADL), UK
Personalized webpage


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