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Drug Registration Process Malaysia

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Drug Registration Process Malaysia

Drug Registration Process - Malaysia

Ministry of Health 

Portal Rasmi Kementerian Kesihatan Malaysia

MoH Link 

https://www.moh.gov.my/

Regulatory Authority

National Pharmaceutical Regulatory Agency (NPRA)

Link for Regulatory Authority 

https://www.npra.gov.my/index.php/en/

Local Authorised

Yes

Classification of Medical Devices

  1. New Drug Product,
  2. Biologics,
  3. Generics,
  4. Health Supplements & Natural Products

Registration Timeline

210 working days

Registration Fee 

RM500 to RM20,000

License Validity  

5 Years

New Drug Product Listing or Registration Requirements

Definition:

New Drug Products (NDP): Refers to any pharmaceutical products that have not been previously registered in accordance with the provisions of the CDCR 1984.

An NDP may be Classified into the following Categories

  1.   New Chemical Entity (NCE) (single/combination products with an active substance never registered by DCA):
  • Definition: An active moiety or radiopharmaceutical substance that has not been registered in any pharmaceutical product.
  • Active Moiety: Defined as the molecule or ion, excluding appended portions causing the drug to be an ester, salt, or noncovalent derivative, responsible for the physiological or pharmacological action of the drug substance.
  • Radiopharmaceutical Substance: Defined as a radionucleotide, ligand, or coupling mechanism linking the molecule and radionucleotide not previously registered in any pharmaceutical product.

1.2 Hybrid (single/combination products with registered active moieties):

  • Definition: All other products registrable at the New Drug Section that do not fall under the NCE category.

Examples of Hybrid (single/ combination) products:

  1. Registered chemical entity(s) in a new chemical form(s)
  2. Registered chemical entity(s) in a new dosage form(s)
  • Registered chemical entity(s) in a new dosage strength(s) with a change in dosing/ posology
  1. Registered chemical entity(s) for use by a new route of administration
  2. Registered chemical entity(s) for new indication(s), dosage recommendation(s) and/ or patient population(s)
  3. Combination of registered chemical entity(s) in new chemical form(s) and registered chemical entity(s)
  • A product for which its innovator has never been registered by DCA
  • Second source product
  • Replacement product 

ITEMS

REGISTRATION REQUIREMENTS

 

ACTD Module

HYBRID

NCE

1) Part I

Yes

Yes

2) Part II (S)1       

Yes

Yes

3) Part II (P)

Yes

Yes

4) Part III

No2

Yes3

5) Part IV

BA/BE/pivotal study report(s), clinical overview and RMP

Full, including RMP

 

HYBRID

NCE

Consultation with local clinical specialists

No

Yes

Evaluation timeline

210 working days

245 working days

For a product in which the reference innovator product has never been registered in Malaysia, specific requirements for Parts III and IV:

  1. Nonclinical Overview, Nonclinical Summary & List of Key Literature References, by referring to studies by the innovator product.
  2. Clinical Overview, Clinical Summary & List of Key Literature References, by referring to studies by the innovator product.
  • Bioequivalence study report(s)
  1. Other pivotal study reports, if applicable
  2. Risk Management Plan (RMP)
  3. Consultation with local clinical specialists

Approval Processes

Pre-Application Stage

  1.  Company Registration: Ensure your company is registered with the Companies Commission of Malaysia (SSM).
  2. Product Classification: Determine the classification of your drug based on its novelty, risk profile, and intended use. This influences the required data and approval pathway.
  3. Consult the NPRA: Seek guidance from the NPRA to understand specific requirements for your drug type. You can also attend their informative workshops and training sessions.
  4. Dossier Preparation: Prepare a comprehensive Common Submission Dossier Template (CSDT) following the ASEAN Common Technical Dossier (ACTD) or ICH Common Technical Document (ICH CTD) format. This dossier includes various modules covering:
    • Drug substance, product, and manufacturing information
    • Non-clinical studies (safety and efficacy data)
    • Clinical studies (human trial data)
    • Quality control and stability data
    • Labelling and packaging

Application Submission

  1. QUEST3 System: Submit your application electronically through the NPRA’s online platform, QUEST3.
  2. Fees and Payment: Pay the associated application fees.
  3. Initial Screening: The NPRA conducts an initial screening within 15 working days to assess if your application is complete and conforms to the format.

Review and Assessment

  1. Technical Review: Experts from the NPRA thoroughly review your dossier, focusing on safety, efficacy, and quality aspects.
  2. Potential Queries: You may receive queries from the NPRA seeking clarification or additional information. Respond promptly and comprehensively.
  3. Meetings and Inspections: The NPRA may request meetings or conduct inspections of your manufacturing facilities and clinical trial sites.
  4. Approval or Rejection:
  • Approval: If all requirements are met, you receive a product registration certificate and can officially market your drug in Malaysia.
  • Rejection: If deficiencies are identified, you may receive a rejection notice with details for resubmission.

Approval Processes for Biologics

Regulatory Compliance for Biologics

Biologics are treated as new products and categorized as high-risk pharmaceuticals, demanding strict adherence to Good Manufacturing Practice (GMP) for both drug substance and drug product production. GMP is integral to the Quality Assurance System, ensuring the highest standards in manufacturing.

Registration Requirements

The registration of biologics/biopharmaceuticals must align with the ASEAN Common Technical Dossier (ACTD) format, following the general regulatory framework outlined in the main DRGD (Drug Registration Guideline Document). The registration dossier should cover:

  1.  Administrative Information
  2. Product Quality Data
  3. Product Safety Data
  4. Clinical Data: This involves demonstrating clinical efficacy and the product’s ability to meet therapeutic claims through comprehensive clinical studies.

Use of Animal-Derived Materials

Biologics often involve the use of animal-derived materials/products. Detailed information justifying the use, including the source, must be provided following Checklist A and Checklist B. Additionally, a confirmation of the presence/absence of animal materials in the final product is required. This confirmation is achieved through Deoxyribonucleic Acid (DNA) testing, utilizing Polymerase Chain Reaction (PCR) or any validated analytical method.

Labelling Requirements

In cases where analytical results are positive, or if DNA test results on the final product are not submitted, labels must prominently disclose information about the animal origin, specifying the name(s) of the animal(s). This ensures transparency and allows end-users to be informed about any potential animal-derived components in the product.

  1. GENERAL INFORMATION

1.1 Definitions

Biopharmaceutical/Biotechnology Product: Refers to proteins produced by recombinant DNA technology.

Biologic/Biological Product: Active substance derived from living organisms using biotechnology methods.

1.2 Introduction

Biologics encompass various products like vaccines, blood products, monoclonal antibodies, recombinant proteins, and cell/gene therapy products. Biosimilars are considered new biological medicinal products developed to be like registered products.

2. Specific Requirements for Registration of Biologics

  1. Requirements for Registration of Vaccines and Biotechnology Products

Vaccines: Defined and subject to Chemistry, Manufacturing, and Control (CMC) requirements.

Biotechnology Products: Defined with additional registration requirements.

  1. Requirements for Registration of Blood Products

Defined with specific registration requirements and checklists.

Checklists of Registration for Products Containing Materials of Animal Origin

Two checklists for products with or without valid Transmissible Spongiform Encephalopathy (TSE) risk evaluation Certificate of Suitability (CEP).

GENERAL INSIGHT

Biological substances’ inherent variability demands attention for quality assurance. Consistency in quality and safety is crucial, especially with advancements in biotechnologies. Demonstration of a product’s safety and efficacy requires thorough characterization, production consistency, stringent controls, and post-marketing surveillance.

2.1 Requirements for Registration of Vaccines and Biotechnology Products

2.1.1 Vaccines

(i) Definition of Vaccine

A vaccine is an immunogen designed to stimulate the immune system, preventing, ameliorating, or treating diseases. It may contain microorganisms, inactivated by chemical/physical means, attenuated living microorganisms, antigens extracted by recombinant DNA technology, or antigens produced in vitro by chemical synthesis.

(ii) Requirements for Registration of Vaccines (Chemistry, Manufacturing, and Controls [CMC])

  1. DESCRIPTION
  • Information on source materials, specifications, and tests for compliance.
  • Detailed description of any chemical modification or conjugation of the drug substance.
  • List of inactive substances.
  1.   Method of Manufacture/ Production
  2.  Manufacturing Formula
  • List of all materials with tests and specifications.
  • Complete formula, including adjuvants, diluents, preservatives, additives, stabilizers, etc.
  • Batch formula for each batch size and lot numbering system.
  1. Manufacturing Process:
  • Detailed description and flow charts of manufacturing processes.
  • Information on cell banking systems, animal sources, and measures to prevent contamination.
  • Description of recombinant vaccines, including vector construction and characterization.
  1. Process Validation Program:
  • General policy and process validation activities.
  1. Handling, Storage, and Packaging:
  • Arrangements for handling materials, packaging, sampling, quarantine, release, and storage.
  1.   Quality Control:
  2.  Starting Materials:
  • Control tests on raw materials with specifications.
  • Biological starting materials with TSE risk evaluation (Certificate of Suitability).
  1. Intermediate Products:
  • Routine tests and specifications for intermediates.
  1. Finished Products:
  • Routine tests and specifications for the final product.
  1. Analytical Validation:
  • Description of bioassay protocols, control standards, and validation activities.
  1.   Stability:
  • Information on stability, quality control methods, and rationale for test choices.
  • Dates of manufacture, lot numbers, and stability data.
  1.   Lot Summary Protocol and Lot Release for Vaccine:
  • Submission of Lot Summary Protocol and Lot Release Certificate from competent authority.
  1.   Nonclinical Studies for Vaccine:
  • Preclinical testing to ensure product characterization, proof of concept, and safety in animals.
  • Testing programs meeting WHO guidelines for nonclinical evaluation of vaccines.
  1.   Clinical Studies for Vaccine:
  • Clinical studies adhering to WHO and international Good Clinical Practice (GCP) principles.
  • Tabulated summary of the clinical development program.
  • Copies of publications related to trials.
  • Detailed clinical summary and an independent clinical expert report.
  1. Post Marketing Surveillance for Vaccines:
  • Outline of post-marketing pharmacovigilance plan.
  • Periodic Benefit-Risk Evaluation Report (PBRER) in accordance with ICH Guideline E2C(R2).
  • Information on ongoing phase IV studies, active monitoring of safety profiles, and adverse events following immunization (AEFI).
  • Risk management plan.

This comprehensive set of requirements covers the entire lifecycle of vaccine development, ensuring safety, efficacy, and quality control from manufacturing to post-marketing surveillance. It aligns with international standards and guidelines to meet regulatory expectations and ensure public health safety. 

Malaysia-Approval Processes for Generics

Definition

A generic product refers to a pharmaceutical product that shares essential similarities with a currently registered product in Malaysia. However, it’s important to note that the term “generic” does not apply to Biologics.

Generic Application

The submission of generic applications is applicable to the following product categories, provided they meet the definition of a generic product:

  1. Scheduled Poison (Controlled Medicine/Controlled Poison)

Products containing active ingredients are listed in the First Schedule under the Poisons Act 1952.

  1. Non-Scheduled Poison (Over the Counter, OTC)

Products containing active ingredients not listed in the First Schedule under the Poisons Act 1952. This category excludes active ingredients categorized under health supplements, natural products, or cosmetics.

  • Full Evaluation: Applies to products not listed under the abridged evaluation category. Abridged Evaluation: Applies to specific products, including but not limited to antiseptics, skin disinfectants, locally acting lozenges/pastilles, topical analgesics, counterirritants, topical nasal decongestants, emollients, demulcents, skin protectants, keratolytic, anti-dandruff, oral care, anti-acne, medicated plasters/patches/pads, and topical antibacterial products.
  • Important Notes: This document must be read in conjunction with the relevant sections of the main guidance document: Drug Registration Guidance Document (DRGD), aligning with the legal requirements of the Sale of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984.

Submission of Application

Applicants are encouraged to refer to Section A (5. Application Procedures) of the DRGD for detailed explanations and guidance on the submission process. This section provides comprehensive information on the procedures applicants need to follow during the application submission process.

REQUIREMENTS FOR GENERIC APPLICATION

  1. Fees
  2. Regulatory Control of Active Pharmaceutical Ingredients (APIs)
  3. Priority Review
  4. Designation and Registration of Orphan Medicines
  5. Evaluation Routes
  6. Requirements for Full Evaluation and Abridged Evaluation
  7. Bioequivalence (BE) Requirements
  8. Product Names Not Permitted to Be Registered
  9. List of Permitted, Prohibited and Restricted Substances
  10. General Labelling Requirements
  11. A Prohibited Visual/ Graphics/ Statements on Label
  12. Specific Labelling Requirements
  13. Special Conditions for Registration of a Particular Product or Group of Products
  14. Educational Materials
  15. Patient Dispensing Pack for Pharmaceutical Products
  16. Appeal
  17. Guideline for the Submission of Protocol of Analysis (POA)
  18. Guideline for the Submission of Analytical Method Validation (AMV) Documents
  19. Inspection
  20. Explanatory Notes for Re-packers

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