RECENT UPDATES
Garispanduan Pelaksanaan Risalah Maklumat Ubat Untuk Pengguna (RiMUP) |
Direktif untuk penggunaan Drug Registration Guidance Document (DRGD) Third Edition, Ninth Revision January 2025 |
Glucagon-like Peptide-1 (GLP-1) Receptor Agonists (Dulaglutide, Liraglutide, Lixisenatide, Semaglutide, and Tirzepatide): Aspiration and Pneumonia Aspiration during General Anaesthesia or Deep Sedation |
Guidelines for Clinical Trial |
Ethambutol: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) |
CALENDAR ACTIVITIES
20 Nov 2024; 08:30AM - 04:15PM MOPI Training 2024: Good Submission Practice 2.0 for Generic Medicines |
12 Nov 2024; 08:00AM - 05:00PM MOPI Training 2024: Good Distribution Practice for the Regulated Industry |
15 Oct 2024; 08:00AM - 05:00PM MOPI Training 2024: A practical approach to ISO 13485 QMS for medical devices |
25 Sep 2024; 08:00AM - 05:00PM MOPI Training 2024: Contamination Control - How to Develop an Effective Contamination Control Strategy |
10 Sep 2024; 08:00AM - 05:00PM MOPI Training 2024: Supply chain management and Supplier QA program-Application of QRM principles |
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