Generic drug registration process in Malaysia

There is a growing demand for generic drugs in Malaysia. The government is the largest pharmaceutical buyer in Malaysia and is responsible for more than half of the purchasing value. The Indian, Chinese, and other similar drug manufacturers have begun playing a dominant role in the Malaysian pharmaceutical market.

Generic drug registration process in Malaysia

In Malaysia, the pharmaceutical manufacturing sector produces exclusively generic drugs, and the sales revenues amount to only 1.5% of gross domestic product (GDP). That shows the great demand for generic medicines in Malaysia.

This demand is due to the steep rise in non-communicable diseases, and some other reasons include,

  • The increase in the prevalence of unhealthy diets,
  • Increasing sedentary lifestyles, and
  • Use of tobacco and alcohol.

Malaysia has one of the highest rates of diabetes in the Asia-Pacific, with almost one-fifth of its population diagnosed with the disease.

Other most found health complications in the Malaysian population include

  • Obesity
  • Hypertension and heart diseases
  • Stoke
  • Respiratory disease
  • Cancer

Definition of generic drug in Malaysia

A generic product is a pharmaceutical product that is essentially similar to a currently registered product in Malaysia. However, the term generic drug does not apply to Biologics.

Types of generic drugs in Malaysia

Generics are classified into two groups

  • Scheduled Poison (Known as Controlled Medicine/Controlled Poison), products containing poisons as listed in the first Schedule under Poisons Act 1952.
  • Non-scheduled Poison (Known as Non-Poison or “Over-the-Counter”, OTC): products containing active ingredients which are not listed in the first schedule under Poisons Act 1952, and exclude active ingredient, which is categorized under health supplements or natural products or cosmetics.

The regulatory authority for generic drug registration in Malaysia

The National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Bureau (NPCB), is the main regulatory body for pharmaceutical products in the country. The NPRA is an organization under the Pharmaceutical Services Division (PSD) of the Ministry of Health (MoH).

The Drug Control Authority (DCA) is the executive branch of the NPRA and is responsible for drug registration, licensing for importers, manufacturers, and drug quality monitoring.

What are various types of generic drug application evaluation processes?

Generic pharmaceutical products

S. No. Product CategoryFull
Evaluation
Abridged Evaluation
1Generics
(Scheduled Poison)
Yes-NA-
2Generics
(Non-scheduled Poison)
[or known as OTC]
All
products
from this
category,
unless stated
in Abridged
Evaluation
Includes, but not limited to the following
 Antiseptics/skin disinfectants
 locally-acting lozenges/ pastilles
 Topical analgesics/counter-irritants;
 Topical nasal decongestants
 Emollient/demulcent/skin protectants, etc.

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Bioavailability (BA)/Bioequivalence (BE) studies

  • Some categories of products require Bioavailability (BA) studies. For example, modified-release products.
  • Bioequivalence Studies are required for the drug products falling under the category of scheduled poison generics.
  • There are some exemptions for submitting BA/BE studies, provided by fulfilling the criteria set by the regulators.

Manufacturing site requirements for generic drug registration

  • Compliance with Good Manufacturing Practice (GMP) is a prerequisite to the application of generic product registration. 
  • It is to ensure that the products manufactured are safe, have efficacy, and are of quality.
  • Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for medicinal products and its annexes have been adopted as the standard used by NPCB to assess the GMP conformity of manufacturers.

Requirements for foreign manufacturers

It is required that the standard of manufacture and quality control of medicinal products manufactured outside Malaysia should be taken into consideration before the products are registered with the authority namely Drug Control Authority (DCA).

One of the requirements to register an imported medicinal product in Malaysia is the submission of acceptable evidence on the GMP compliance of the manufacturer in a prescribed format.

The drug registration process in Malaysia

  • The company must register with the Malaysian Registrar of Business (ROB) or the Companies Commission of Malaysia (SSM).
  • All new drug applications must be submitted through a web system to the DCA.
  • The applicant must submit the required documents to support an application for product registration following ACTD guidelines.
  • The evaluation committee with NPCB will evaluate the application and may
    • Accept
    • Reject
    • Order for Re-assessment
  • A complete application shall be accepted and approved for payment.
  • Upon approval during screening, the applicant is requested to proceed with payment and submission of hard copy documents.

Generic drug registration process in Malaysia

Review fees for generic applications

The fee for review of the various generic drug products is approximately between RM 2,200.00 to RM 3,000.00.

Timelines for generic applications review

The timeline for drug approval is

  • The standard route has a target time of 365 days,
  • The abbreviated route has a target timeline of 180 days, and
  • The verification route has a target of 135 days.

Post-approval distribution process

  • Any company who wishes to manufacture, import, and/or wholesale any registered products needs to have a Manufacturer’s Licence, Import Licence, and/or Wholesaler’s License.
  • The application form must be submitted with the supporting documents. For the complete list of documents please click on the link below to download the report.
  • An application shall only be processed, if it is complete and the payment has been approved.
  • The processing fee shall not be refundable. The processing fee of an application for a Manufacturer’s License is RM1,000.00 and RM500.00 for an Import License or a Wholesaler’s License.
  • Each license is valid for one one year.

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References

  1. http://npra.moh.gov.my/images/reg-info/DataEx/Directive_on_DE.pdf.
  2. Drug Registration Guidance Document, National Pharmaceutical Control Bureau First Edition, January 2013, Revised January 2016, 100~112page
  3. Drug Registration Guidance Document (DRGD), APPENDIX 2: REQUIREMENTS FOR PRODUCT REGISTRATION, National Pharmaceutical Control Bureau (NPCB) First Edition, January 2013. Revised January 2016.
  4. https://www.pacificbridgemedical.com/publication/malaysia-drug-market-update-2017/