Generic Product Registration

Introduction

What is Generic Medicine?

A generic product refers to a product that is essentially equivalent to an existing registered product in Malaysia. However, the term “generic” does not apply to biologic products. Generics can be further divided into two categories:

1. Scheduled Poison
Also known as Controlled Medicine or Controlled Poison, these are products containing substances listed in the First Schedule of the Poisons Act 1952.

2. Non-Scheduled Poison
Also referred to as Non-Poison or Over-the-Counter (OTC) products, these contain active ingredients not listed in the First Schedule of the Poisons Act 1952. This category excludes products where the active ingredients are classified under health supplements, natural products, or cosmetics.

Non-Scheduled Poison products are further evaluated through two possible approaches:

  • Full Evaluation
  • Abridged Evaluation
Generic Product Registration in Malaysia

Product Registration Process

Generic Product Registration in Malaysia

Frequently Asked Questions

What are generic products?
A generic product refers to one that is essentially equivalent to an already registered product in Malaysia. However, the term "generic" does not apply to biologic products.

Generic products are classified into two categories:

i. Scheduled Poison (also known as Controlled Medicine or Controlled Poison):
These are products that contain substances listed in the First Schedule of the Poisons Act 1952.

ii. Non-Scheduled Poison (also known as Non-Poison or Over-the-Counter (OTC)):
These products contain active ingredients not listed in the First Schedule of the Poisons Act 1952 and exclude those classified under health supplements, natural products, or cosmetics.
If there is more than one source of the Active Pharmaceutical Ingredient (API), is it necessary to submit stability data for the finished product from each source?
No, stability data from batches using one of the API sources is sufficient.
What is the reference guideline for conducting stability studies of finished products for registration in Malaysia?
The applicable guideline is the ASEAN Guideline on Stability Study of Drug Product (R1), adopted during the 25th ACCSQ-PPWG meeting. This document is available on the NPRA website.
What are the reference guidelines for process validation of finished products to be registered in Malaysia?
The relevant documents are the ASEAN Guidelines on Process Validation, including Annexes A1, A2, A3, B, C, and D. These guidelines are available on the NPRA website.
What are the bioequivalence requirements for product registration submission in Malaysia?
Please refer to the NPRA website for detailed information on bioequivalence requirements for generic medicines.
Where can I find the list of Malaysia Comparator Products (MCP) for applications involving bioequivalence studies?
Please refer to the NPRA website for the list of Malaysia Comparator Products (MCP) used in bioequivalence (BE) studies.
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