Farmakovigilans

NPRA sentiasa berusaha menjamin keselamatan produk ubat-ubatan melalui farmakovigilans. Farmakovigilans adalah sains dan aktiviti berkaitan pengesanan, penilaian, pemahaman dan pencegahan kesan advers atau masalah ubat-ubatan lain. [1]

 

Antara aktiviti farmakovigilans yang dijalankan oleh NPRA adalah pemonitoran kesan advers ubat (ADR) dan penyaringan makluman isu keselamatan ubat. Aktiviti-aktiviti ini membolehkan isu keselamatan ubat dikenal pasti dan dinilai untuk melaksanakan tindakan pengurangan risiko. NPRA juga berkomunikasi dengan ahli profesional kesihatan dan orang awam berkaitan isu keselamatan ubat, dalam usaha berterusan untuk meningkatkan keselamatan pesakit.

 

Rujukan: 1. WHO (2002). The Importance of Pharmacovigilance: Safety monitoring of medicinal products. pp 7-8

Kemaskini Terkini, Direktif & Pekeliling


  • Kemaskini Terkini untuk Garispanduan, Pekeliling, Direktif, Soalan Lazim (FAQ) & Pengumuman untuk Farmakovigilans 
  • Direktif & Pekeliling berkaitan dengan Farmakovigilans

Drug Registration Guidance Document : Edisi Kedua – September 2016, semakan July 2018

PREAMBLE

  • DOKUMEN PANDUAN PENDAFTARAN DRUG (DRGD) ini akan menjadi panduan rujukan untuk proses pendaftaran termasuk kawalan kualiti, pemeriksaan & pelesenan dan aktiviti pasca pendaftaran produk ubat. Dokumen ini akan menggantikan “DRUG REGISTRATION GUIDANCE DOCUMENT” Edisi Kedua, 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

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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