Medicinal Products Regulatory Support in Malaysia

Overview

The Drug Control Authority (DCA) regulates medicinal products in Malaysia. The DCA was formed under the Drugs and Cosmetics Regulations (CDCR), 1984, from the Sale of Drugs Act 1952. The DCA is also a stakeholder in quality control, licensing, and post-registration activities. The National Pharmaceutical Regulatory Agency (NPRA) carries out scientific and technical reviews, inspections, and surveillance activities. Additional activities carried out by the DCA include cosmetic registration and reporting of ADRs (Adverse Drug Reactions). NPRA Malaysia is one of the participating authorities in the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Medicinal Product Classification

Medicinal products are classified into the following categories:

  • New Drug Product (NDP)
  • Biologics
  • Generics [Prescription Medicine & Non-prescription Medicine, Over-the-Counter (OTC)]
  • Health and Food Supplements
  • Natural Products
  • Veterinary Products
  • Medicinal Gas

Medicinal Product Registration

It is important to determine product category due to the different Regulatory requirements for distinct pharma product registration activities. If unsure of the product category, the applicant may submit a classification form which can be downloaded from the NPRA website (www.npra.gov.my).

The pharmaceutical product applicant is known as the Product Registration Holder (PRH). A PRH must be a locally incorporated company, corporate, or legal entity with a permanent address and should be registered with the Companies Commission of Malaysia. For any foreign medicinal product manufacturer, it is mandatory to have a local entity or local presence in Malaysia to carry out Regulatory activities and registration procedures with the NPRA. The appointed agent would then be responsible for all the matters relating to product quality, safety, and efficacy.

Registration of products shall be done via the web-based QUEST 3+ Online System. The drug company must follow the Association of Southeast Asian Nations (ASEAN) Common Technical Documents (ACTD) to be certified as compliant.

ASEAN Common Technical Document (ACTD)

Parameter

Certificate/Document required

Quality

GMP certificate, Product testing data specification, Microbial limit test, and other required quality documents, if required

Safety

Preclinical & clinical analysis data, product information - warning labels/precautions/drug interactions/adverse effects and other required safety documents, if required

Efficacy

Clinical trial data - Phase 2 & 3, bioequivalence studies, and other required efficacy documents, if required

Regulatory Pathway for the Registration of Medicinal products

Malaysian Regulatory Pathway for Medicinal Products Registration


If the manufacturing site is in any of these reference countries - USA, Canada, UK, Europe, Japan, Australia, and Singapore, NPRA site visit is not required unless they have a certain reason for inspection, and the review process can be expedited for quicker pharma market access.

API manufacturers are required to have a WHO GMP certification to register their finished products. The WHO GMP certification is mandatory to get the site and product registrations completed.

Product Maintenance & Compliance

Sr. No

Application

Validity

01

Validity for Registration Certificate

Five (05) years from the date of registration

02

Renewal of Registration certificate

The renewal application should be submitted six (06) months before the expiration of the existing registration certificate

03

Post-approval Changes (Variations)

Any change of registered medicine should be sent to the NPRA with relevant documents, on a case-by-case basis

Freyr Expertise

  • Authorized Local Representation
  • Product Classification
  • Regulatory Affairs Consulting and Pharma Market Access
  • End-to-end Pharmaceutical Product Registration
  • Gap Analysis, Pharmaceutical Dossier Preparation, and Submission to the NPRA
  • Preclinical Services (Generation of Scientific Reports for Regulatory Submissions)
  • Import License Application
  • NPRA Product Registration
  • Change of Product Registration Holder
  • Ad-hoc Regulatory Affairs Consultation

Location

Suite 163E, Level 16,
Gurney Paragon Office Tower,
Jalan Kelawei, 10250 George Town,
Pulau Pinang, Malaysia

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