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Health Professionals

The information in this section is for health providers, such as doctors, pharmacists, nurses, medical assistants, etc. and not present as medical advice to health professionals.

Safety Alerts & NPRA 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.

Quality Reporting

Please use this form to report for quality reporting of registered product (e.g. quality, efficacy, labelling, packaging) NOT related to ADRs.

Products Search

Search Pharmaceutical, Complimentary & Alternative Products that registered with National Pharmaceutical Regulatory Agency, NPRA. You may also search cosmetic products notified with NPRA

Summary Report on Adverse Events Following Immunisation of COVID-19 Vaccines in Malaysia

This report provides summarised updates on adverse events following immunisatAion (AEFIs) of COVID-19 Vaccines in Malaysia.

To receive the latest safety issues including COVID-19 Vaccines AEFI Summary Report, you may join the NPRA Safety Information Mailing List by submitting details of your name, profession and workplace through email to fv@npra.gov.my (please put in NPRA Safety Mailing List as the subject of your email).

The summary report is only available in English.

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.

Consumer Information

Consumer Reporting of Side Effects to Medicines or Vaccines

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 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

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

Safety Information

Cancellation of Registered Complementary & Alternative Product

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 )

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

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.

Vaccine Lot Notification of Non-Compliance

Plasma Products Lot Notification Non-Compliance

NPRA Facebook Page

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 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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DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Wednesday 18 May 2022, 18:46:01.
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