Combination Products

Introduction

  • Drug-medical device/ medical device-drug combination products are regulated according to the classification whether as drug or medical device.
  • Combination products regulated as drug by Drug Control Authority is in accordance with the requirements set forth in the Control of Drugs and Cosmetics Regulations 1984 which is promulgated under Sale of Drug Act 1952 and any other relevant documents published by NPRA.
  • Combination products regulated as medical device by Medical Device Authority is in accordance with the requirements set forth in the Medical Device Act 2012 (Act 737) and its subsidiary legislations, and any other relevant documents published by MDA.
  • Any drug substances used as ancillary to medical device which is listed as a scheduled poison shall be regulated in accordance with the Poison Act 1952.

Recent Updates, Directives & Circulars


  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Combination Products
  • Directives & Circulars Related to Combination Products

Drug Registration Guidance Document : Second Edition – September 2016, revised July 2018

PREAMBLE

  • This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products. This document will replace the “DRUG REGISTRATION GUIDANCE DOCUMENT” Second Edition, September 2016.
  • This DRGD shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing pharmaceutical and natural products for human use in Malaysia, which include but not limited to the following:

a) Sale of Drugs Act 1952;
b) Control of Drugs and Cosmetics Regulations 1984;
c) Dangerous Drugs Act 1952;
d) Poisons Act 1952;
e) Medicines (Advertisement & Sale) Act 1956;
f) Patents Act 1983;
g) Wildlife Conservation Act 2010 (Laws of Malaysia Act 716); and
h) International Trade in Endangered Species Act 2008 (Act 686).
The written laws shall take precedence over this guidance document in any event of discrepancy.

 
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DRGD Update

List of DRGD Updates Download
List of DRGD Updates - October 2018 October 2018
List of DRGD Updates - August 2018 August 2018
List of DRGD Updates - July 2018 July 2018
List of DRGD Updates - June 2018 June 2018
List of DRGD Updates - April 2018 April 2018
List of DRGD Updates - March 2018 March 2018
Drug Registration Guidance Document (DRGD) Second Edition - September 2016, revised January 2018 January 2018

Product Registration Process

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National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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