Generic Medicines

A generic product is a product that is essentially similar to a currently registered product in Malaysia. However, the term generic is not applicable to Biologics. Generic may be further classified into two groups :Scheduled Poison
(Known as Controlled Medicine/ Controlled Poison) Products containing poisons as listed in the First Schedule under Poisons Act 1952.Non-scheduled Poison
(Known as Non-Poison or “Over-the-Counter”, OTC) Products containing active ingredients which are not listed in the First Schedule under Poisons Act 1952; and is excluding active ingredient which is categorized under health supplements or natural products or cosmetics.
Non-Schedule Poison can be categorized into two separate method of evaluation :

1. Full Evaluation
2. Abridge

• Frequently Asked Questions (FAQs)
• Guidelines for Generic Medicine
• Directives & Circulars
• Active Pharmaceutical Ingredients
• Bioequivalence
• Downloadable Forms
• HSA-NPRA Work Sharing Initiative