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Safety Alerts & NPRA Recent Updates
Safety Alerts
Recent Updates
Reporting ADR/AEFI by Healthcare Professionals
Please report ALL suspected Adverse Drug Reactions (ADRs) (including those for traditional products) and Adverse Events Following Immunisation (AEFIs) to the National Centre for Adverse Drug Reactions Monitoring.
Do not hesitate to report if some details are not known.The identities of Reporter, Patient and Institution will remain confidential.
Reporting by Healthcare Professionals
Please use this form to report product complaints (e.g. quality, efficacy, labelling, packaging) NOT related to ADRs.
Registered Products Complaints (Related to Medicine) Form [PDF]
Search Pharmaceutical, Complimentary & Alternative Products that registered with National Pharmaceutical Regulatory Agency, NPRA. You may also search cosmetic products notified with NPRA
NEWSLETTER: MADRAC BULLETIN
The MADRAC Bulletin provides information on the activities of the Malaysian Adverse Drug Reactions Advisory Committee, which meets bimonthly and advises the Drug Control Authority (DCA) on local and international drug safety issues.
REAKSI DRUG SAFETY NEWS
This publication provides information and recommendations to healthcare professionals to enhance communication of drug safety updates, raise
awareness of adverse drug reactions reported, and stimulate additional adverse drug reaction reporting.
View All REAKSI Drug Safety News
Consumer Reporting of Side Effects to Medicines or Vaccines
To report a suspected side effect or adverse drug reaction (ADR) to any medicine (including prescription, over-the-counter, traditional product, health supplement, etc.)
or adverse event following immunisation (AEFI) to any vaccine.
Consumer Medication Information Leaflets (RiMUP)
Consumer Medication Information Leaflet (RiMUP) is a copy of patient information leaflet for a medicine,
which outlines the conditions under which the medicine should be used and information on its
known safety.
Online Public Engagement
This page is available for public consultation and will present new proposals or amendments to the draft law (including laws, policies, regulations, etc.). The draft will appear on this page within 14 working days. The public is encouraged to provide comments and views on the NPRA during this period.
Vaccine Lot Release Certificate
Plasma Products Lot Release
Search Plasma Products Lot Release
Cancellation of Registered Complementary & Alternative Product
Produk-produk ini didapati mengandungi bahan kimia, termasuk racun berjadual yang tidak dibenarkan dalam Produk Komplementari dan Alternatif. Penggunaan produk-produk ini yang dicampurpalsu dengan bahan kimia seperti yang telah dikesan boleh menyebabkan kesan advers serius.
Adulterated Poducts ( Unregistered )
NPRA telah menerima laporan kesan sampingan berkaitan produk-produk yang tersenarai di bawah dan hasil ujian yang telah dijalankan mendapati bahawa produk-produk ini telah dicampurpalsu dengan bahan terlarang atau racun berjadual.
Cancellation of Notified Cosmetic Products
Produk-produk ini telah didapati mengandungi bahan larangan, termasuk racun berjadual yang tidak dibenarkan dalam produk kosmetik. Penggunaan produk kosmetik yang dicampurpalsu dengan bahan kimia seperti yang telah dikesan boleh menyebabkan kesan advers serius.