[
English
] [
A
|
A+
|
A++
] [
■
|
■
|
■
]
Home
|
Sitemap
|
Contact Us
About NPCB
Introduction
Vision, Mission & Objective
Organisational Chart
Roles and Functions
Client Charter
Information
Obligation
Previous Year (2012)
Service Level Achievements
Online Web-Statistics & Analytics
Recognition & International Membership
WHO Collaborating Centre
PIC/S
OECD – GLP – MAD
MS-ISO (Quality System)
Market Surveillance Membership
ASEAN Committee
NPCB Awards & Recognition
Drug Control Authority (DCA)
Introduction
DCA Members
DCA News
Malaysian Adverse Drug Reactions Advisory Committee (MADRAC)
Introduction
MADRAC Members
Research & Project Collaboration
Contact Us
Address/Phone Directory
Location Map
Feedback Form
Consumers
Information
Patient Information Leaflet (PILs) / Risalah Maklumat Ubat Pengguna (RiMUP)
Reporting
Reporting medicinal problems
Reporting of Adverse Events Following Immunisation (AEFI)
FAQ on Reporting
Industry
General Information
Drug Registration Guidance Document (DRGD)
Regulatory Information
Regulatory Guidelines
Bioequivalence (BE)
Data Exclusivity
Registration and Notification
QUEST
Medicinal Products
Cosmetics
Veterinary
Template/Guide for Product Information (PI) for generic product
Product Recall Procedures
Inspection
GMP/GDP
Foreign GMP Inspection
Licensing
New Products/Indication
New Products Approved (QUEST3)
New Products Approved (QUEST2)
New Chemical Entities
Additional Indications Approved
Laboratory & Quality Control
Guidelines for Protocol of Analysis submission & Analytical Method Validation
Guidelines for Sample Submission
List of Accredited Laboratories*
Forms
Clinical Trial
Good Laboratory Practice (GLP) Compliance Monitoring Programme
Quest2 List of Manufacturers / Wholesales / Importers
Quest3 List of Manufacturers / Wholesales / Importers
Healthcare Professionals
Information
Safety Alert
Reporting
Adverse Drug Reaction
Product Complaint
Cutaneous ADR Classification
News & Publication
Information
News & Announcements
Circulars
Publications
NPCB Annual Reports
WHO-CC NPCB Annual Reports
Newsletter: Berita Ubat-ubatan
Newsletter: MADRAC Bulletin
MADRAC Annual Reports
Newsletter: Reaksi
Cancellation of
Traditional/Cosmetic Product
Cancellation of Registration of Traditional Products
Cancellation of Notification of Cosmetic Products
Training & Seminars
Guidelines Central
Product Search
Information on Product Searches
FAQ
Frequently Asked Questions
FAQ: Quest2/Quest3
Online Submission System
FAQ: Product Registration
FAQ: Active Pharmaceutical Ingredient (API)
FAQ Veterinary
FAQ: Cosmetic
FAQ: GLP
FAQ: GMP/GDP
FAQ: Licensing
FAQ: Reporting by Marketing Authorisation Holders
FAQ: Reporting on Cosumers
FAQ: Reporting for Healthcare Professionals
Search NPCB Portal
Loading
NEWS & PUBLICATION
Information
News & Announcements
Circulars
Publications
Cancellation of
Traditional/Cosmetic Product
Training & Seminars
Guidelines Central
News & Announcements
Title:
New Drug Registration Guidance Document (DRGD) - effective 1st January 2013
Date:
28 December 2012
Category:
Drug Registration Guidance Document Updates
Description:
Please read these news announcements regularly for AMENDMENTS and CHANGES to the DRGD.
Click
here
to download the New Drug Registration Guidance Document.
[
Back
]
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia. Tel: +603-78835400 Fax: +603-79562924, 79567075
Copyright © 2002 - 2013 NPCB. All Rights Reserved. |
Disclaimer
|
Privacy
|
Security
|
MSC
MyGov
BLESS
KKM
Pharmacy
ZIMBRA
MyCPD
HRMIS
KYM
MyHealth
MDC
Accredited Lab
Last Updated:
22 May, 2013
Access Time:
0.36 seconds
1,771,966 no. of visits
since Jan-2012
Click to view
Site Analytics/Graphs
Best Experienced with:
Chrome, Webkit, Firefox, IE9
QR Code
RSS Feed
Client Charter
