Hebahan Program Kuala Lumpur Pharmacy Run 2019

QUEST3+ System Registration ProcessHow to register as a user in QUEST3+ system?

Registration for the QUEST 3+ System is simple,
and no regulatory consultant/agent* services should be required

Quality Control Centre has maintained theMS ISO/IEC 17025:2005

accreditation certificate by Jabatan Standards Malaysia on 30 August 2018.
Accreditation will be valid until 30 November 2020

SCAM TELEPHONE CALLSNOTICE

Recently, the NPRA has received reports from the public regarding scam telephone calls that
were made by individuals who claimed to be NPRA officers.

More Information

NPRA mission is to safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.

Consumers

ConSERF, AEFI Reporting, RiMUP, Product Cancellation & etc

Health Professionals

Safety Alert, Reporting ADR, MADRAC, Product Complaints, Publications

Industries

Product Registration, QUEST3+ System, Guideline Central, Application Forms, FAQs.

PRODUCT SEARCH

Check product status including pharmaceutical, natural & cosmetic products

Product Status

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

To report a suspected side effect or adverse drug reaction (ADR) to any medicine or vaccine

Report ADR as Consumers

Report ADR as Health Care Professional

ANNOUNCEMENTS
RECENT UPDATES
PRESS RELEASE
DIRECTIVES & CIRCULARS
SAFETY ALERTS
CALENDAR ACTIVITIES

15Oct

Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020

05Aug

Manufacturer's / Importer's / Wholesaler's Licence Renewal Application for Year 2020

10Jul

Training Seminar on ICH Stability Guidelines (ICH-Q1)

View All Announcements

Keperluan Acknowledgement Receipt/ Endorsement Letter bagi pendaftaran baru/ pendaftaran semula produk kombinasi ubat-peranti perubatan (Drug-Medical Device Combination)
published on 2019-10-14

List of Renewal Approved Veterinary Products
published on 2019-10-08

Additional Indications Approved
published on 2019-10-08

New Products Approved
published on 2019-10-08

Penguatkuasaan keperluan kajian bioekuivalens (BE) dan akreditasi pusat kajian BE bagi produk generik tetapi produk inovator tidak pernah didaftarkan di Malaysia
published on 2019-10-03

More Recent Updates

01Oct

Keperluan Acknowledgement Receipt/ Endorsement Letter bagi pendaftaran baru/ pendaftaran semula produk kombinasi ubat-peranti perubatan (Drug-Medical Device Combination)

03Oct

Penguatkuasaan keperluan kajian bioekuivalens (BE) dan akreditasi pusat kajian BE bagi produk generik tetapi produk inovator tidak pernah didaftarkan di Malaysia

05Sep

BIL.1/2019 MAKLUMAN BERKENAAN STATUS KEMASKINI BAHAN-BAHAN DALAM ANNEX PADA GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA (5 SEPTEMBER 2019)

View All Directives & Circulars

03Sep

Clopidogrel: Interaction with boosted antiviral Human Immunodeficiency Virus (HIV) therapy leading to insufficient inhibition of platelet aggregation

03Sep

LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis

26Aug

Diclofenac (systemic use): (i) Risk of anastomotic leakage and (ii) Risk of Kounis syndrome

View All Safety Alerts

18 Nov 2019;
08:00AM - 05:00PM
Good Distribution Practices for the Regulated Industry

20 Nov 2019;
08:00AM - 05:00PM
Supply Chain Management

02 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Effective Communication at the Workplace

03 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Reasoning and Decision Making

04 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Managing Change – assessing the resistance and readiness

View Full Calendar