Pharmaceutical & Generic Product Registration
Navigate the product registration process for original and generic pharmaceuticals in Malaysia seamlessly. We provide full support for dossier preparation, bioequivalence evaluation, NPRA submissions, and regulatory approval.
Introduction
What Defines a Generic Medicine?
In Malaysia, a generic medicine is a pharmaceutical product designed to be functionally identical to an already approved reference drug. Note that biological treatments are excluded from this classification. Generic pharmaceuticals fall into two primary groups:
1. Scheduled Poisons
Commonly termed Controlled Poisons or Prescription Medicines, these items incorporate active substances specified under the First Schedule of the Poisons Act 1952.
Commonly termed Controlled Poisons or Prescription Medicines, these items incorporate active substances specified under the First Schedule of the Poisons Act 1952.
2. Non-Scheduled Poison
Frequently called Over-the-Counter (OTC) or Non-Poison items, these formulations consist of active ingredients outside the First Schedule of the Poisons Act 1952. This group excludes items categorized as natural health products, nutritional supplements, or cosmetic formulations.
Frequently called Over-the-Counter (OTC) or Non-Poison items, these formulations consist of active ingredients outside the First Schedule of the Poisons Act 1952. This group excludes items categorized as natural health products, nutritional supplements, or cosmetic formulations.