RECENT UPDATES
Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness |
Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use |
[Updated] Loperamide: Risk of Acute Pancreatitis |
Direktif Berkenaan Pengemaskinian dan Pelaksanaan Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023 |
Thanks for Joining #MedSafetyWeek 2023 💖 |
CALENDAR ACTIVITIES
18 Jan 2024; 09:00AM - 05:30PM ISPE Online GDP Seminar : Module 1 (QMS & Documentation ) |
18 Dec 2023; 08:00AM - 05:00PM TMHS Industry Training 2023: PQR and Verification |
03 Oct 2023; 08:30AM - 05:00PM Latihan Industri: Ke Arah Pelaksanaan Pengujian Kawalan Kualiti Ke Atas Bahan Mentah Herba Bagi Pengilang Produk Semulajadi |
15 Aug 2023; 08:00AM - 05:00PM National Regulatory Conference (NRC) 2023 |
22 May 2023; 09:00AM - 05:00PM ISPE Malaysia Education Series: Strengthening GDP Fundamentals |
Regulatory Information
Any matters related to inspection of bioequivalence (BE) centres & listing of ethics committee (EC) with Drug Control Authority (DCA).
Medicinal gases are gases or gas mixtures intended for the administration to patients for medicinal purpose such as anaesthetic, therapeutic, prophylactic and diagnostic use.
Product Categories
Browse Guidelines, Directives, Circulars, Announcements and Application Forms according to Product Categories