Frequently Asked Questions (FAQs) : Generic Medicines
1. What are generic products?
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 biologic products.
Generics may be further classified into two groups:
i. Scheduled Poison(Known as Controlled Medicine/ Controlled Poison)
- Products containing poisons as listed in the First Schedule under Poisons Act 1952.
ii. 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.
2. If there are more than one source of Active Pharmaceutical Ingredient (API) , does the stability data for finished product for all sources need to be submitted?
3. What is the guidance document for stability studies of finished products to be registered in Malaysia?
4. What are the guidance documents for process validation of finished products to be registered in Malaysia?
5. What are the bioequivalence requirements for the purpose of product registration submission in Malaysia?
6. Where is the list of Malaysia comparator products (MCP) for applications with bioequivalence studies?
7. What is the basis for a product to be categorised as Abridged Evaluation, Non Scheduled Poison/OTC products?
8. What is the difference in the registration requirements between the Abridged and Full Evaluation for Non Scheduled Poison/ OTC products?
9. What are the drug substance(DS)/Active Pharmaceutical Ingredient (API) registration requirements for Non Scheduled Poison/ OTC category?
