Generic Medicine
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 :
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 :
- Full Evaluation
- Abridge
Recent Updates on Generic Medicine
Product Registration Process
Step I : Preparation
Product Classification, Token Configuration, Payment Mode, Patent and Data Exclusivity Status and Ensure Key Documents Availability.
Pre-submission of Application (Preparation)
Step I : PreparationStep 2 : Submission
Key-in, upload documents and submit your application (Part I, Part II, Part III & Part IV)
Product Validation, Part I, Part II, Part III & Part IV
Step 2 : SubmissionStep 3 : Regulatory Outcome
Evaluation of Application & Drug Control Authority (DCA) Decision.
Evaluation of Application & Drug Control Authority (DCA) decision.
Step 3 : Regulatory OutcomeStep 4 : Post-registration Process
Maintenance of Registration, Withdrawal of Product Registration, Amendment to The Particulars of The Product, Post Marketing Activities
Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities
Step 4 : Post-Registration Process