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
REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES
To report a suspected side effect or adverse drug reaction (ADR) to any medicine or vaccine
Kenyataan Akhbar KPK 6 Ogos 2019 – Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual |
New Products Approved |
Biosimilars Approved |
Direktif Untuk Penggunaan Drug Registration Guidance Document (DRGD) Second Edition, September 2016, Revised July 2019 |
Direktif untuk semua produk yang mengandungi lamotrigine: Pengemaskinian sisip bungkusan dan risalah maklumat ubat untuk pengguna (RiMUP) dengan penambahan maklumat keselamatan berkaitan risiko Brugada-Type ECG |
| 19 Aug 2019; 08:00AM - 05:00PM Root Cause Analysis and CAPA |
| 23 Sep 2019; 08:00AM - 05:00PM Computer Systems for Regulated Environment and Data Integrity |
| 07 Oct 2019; 08:00AM - 05:00PM Solid Dosage Manufacture Principles and Practices |
| 18 Nov 2019; 08:00AM - 05:00PM Good Distribution Practices for the Regulated Industry |
| 20 Nov 2019; 08:00AM - 05:00PM Supply Chain Management |
