Comprehensive Guide to Drug Registration and Regulatory Compliance in Malaysia

wwy
Aug 4
3 min read

Malaysia's pharmaceutical sector is experiencing substantial growth, fueled by government incentives, access to ASEAN markets, and a strengthening regulatory environment. Understanding the drug registration process and regulatory framework is vital for successful market entry and continued compliance.

Regulatory Framework in Malaysia

Key Legislation:

Poisons Act 1952: Regulates the handling of poisons, including their manufacture, sale, and use. It categorizes poisons and restricts their distribution to ensure public safety.
Dangerous Drugs Act 1952: Prohibits illicit drug trafficking, with penalties including the death penalty or life imprisonment.
Sale of Drugs Act 1952: Governs the sale of drugs.
Control of Drugs and Cosmetics Regulations 1984 (CDCR): Ensures the quality, safety, and efficacy of pharmaceutical and cosmetic products through registration, licensing, and monitoring

Regulatory Authorities:

National Pharmaceutical Regulatory Agency (NPRA): Ensures the safety, efficacy, and quality of pharmaceuticals, traditional supplements, and cosmetics in Malaysia through drug evaluation, technical review, GMP inspections, and market surveillance.

Drug Control Authority (DCA): Makes final decisions on drug registration and pharmacovigilance based on NPRA’s recommendations.

Product Classification for Registration

Before starting the registration process, applicants must determine the product category, as each type requires different documentation:

New Drug Products (NDP)
Biologics and Biosimilars
Generics (Prescription Medicines)
Over-the-Counter (OTC) Drugs
Veterinary Products
Traditional Medicines & Health Supplements
Cosmetics

Official registration guidelines for each product category are outlined in NPRA’s Drug Registration Guidance Document (DRGD). Applicants are also advised to consult ASEAN guidelines, European Medicines Agency (EMA) standards, and International Council for Harmonisation (ICH) guidance where applicable.

Key Stages of Drug Registration in Malaysia

Initial Screening → Payment → Evaluation → Correspondence (5 rounds) → Approval / Rejection

Timeline: Typically 6 to 18 months post-payment, depending on the product category and communication process.

3.1 Pre-Registration Preparation

Preparation of Registration Dossier
GMP Certificate (GMP Status Verification):
Whichever is not a PIC/S member, NPRA requires on-site GMP inspection, which can be time-consuming.
Bioequivalence (BE) Study: Required for generics.
Stability Studies must follow Zone IVB conditions:
- Real-time testing (30°C / 75% RH): 12 months
- Accelerated testing (40°C / 75% RH): 6 months

3.2 Evaluation Stage (NPRA Assessment)

Regulatory Decision:
Upon reviewing the submitted documents (and product samples, if applicable), NPRA may approve or reject the application.

Products that fail to meet safety, quality, or efficacy standards, or fail to comply with registration requirements, may be rejected, suspended, or cancelled under Regulation 11(1) of CDCR 1984.

Product Registration Number (MAL No.):
Once approved, a MAL registration number is issued to the product. This number is unique to the specific product name, composition, and manufacturer, and cannot be reused for other products.

3.3 Post-Marketing Obligations

Continuous monitoring of product safety
Mandatory reporting of Adverse Drug Reactions (ADRs)
Submission of pharmacovigilance data
Ensuring consistency between actual product performance and approved labeling

Fast Track Review Pathway – Essential for Time-Critical Products

Eligibility:

Public health emergencies or pandemic-related products
Life-saving drugs with no existing alternatives
First-to-market generics or biosimilars

Expedited Timelines (from approval to fast-track):

New drugs & biologics: 120 working days
Generic drugs: 100 working days

Product Classification Reminder:

Applicants must first determine whether the item falls under:

Conclusion

Gaining a clear understanding of the essential procedures and documentation requirements for drug registration in Malaysia enables companies to navigate the regulatory landscape with greater precision, minimize delays, and expedite market entry.