Malaysia drug approval regulatory

According to a recent analysis by an agency, the Malaysian pharmaceutical market is anticipated to increase from $2.3 billion in 2015 to $4.6 billion by 2022, reflecting a 9.5% compound annual growth rate (CAGR). Seeing this demand many manufacturers are showing interest in registering their drug products in Malaysia.

Malaysia drug approval regulatory

Malaysia’s efforts to increase access to healthcare and enact business-friendly laws have led to a continued influx of foreign investment into the country’s medical manufacturing sector. Additionally, Malaysia’s growing middle-class income levels, improved medical diagnosis techniques, the prevalence of chronic diseases, and health consciousness demonstrate the country’s expanding market potential for western medical businesses.

What are the regulatory authorities for pharmaceuticals in Malaysia?

  • The Ministry of Health (MOH) is Malaysia’s top government organization in charge of the nation’s healthcare system as a whole and the health of its population.
  • The National Pharmaceutical Regulatory Agency (NPRA) is responsible for the standards for testing and quality control procedures and overseeing the quality control of pharmaceutical products.
  • All pharmaceutical, health, and personal care products sold in Malaysia must be safe, effective, and of high quality, according to the Malaysian Drug Control Authority (DCA).
  • Following the DCA, the Malaysian Adverse Drug Reaction Advisory Committee (MADRAC) conducts pharmacovigilance for medicines authorized in Malaysia.

The approval process for new drug application in Malaysia

The regulation 2 of the Control of Drugs and Cosmetics Regulations of 1984 defines a drug product in Malaysia as,

  • A medication, whether in a dosage unit or not, is intended to be delivered to one or more humans or animals for medical purposes; or
  • An ingredient in a medical preparation that contains a medication.

The Drug Control Authority (DCA) has given its approval for the use or sale of products that have been registered in Malaysia. These products have been evaluated and tested for their quality and safety.

Types of pharmaceuticals that you can register in Malaysia.

The following are a few examples of the various drug products that you can register with DCA:

New drug products

  1. New chemical entities
    • product with an active moiety or radiopharmaceutical ingredient not approved for use in a pharmaceutical product.
  2. Hybrid
    • Other goods, such as combinations of NCEs that have been registered, new dosage forms, new strengths, and novel administration routes [abbreviated product dossiers are permitted]

Biologics

A biologic product is one whose active ingredient is created by or obtained from a living thing (plant, human, animal or microorganism).

  1. Vaccines 
  2. Medicines made from blood or plasma Products derived from biotechnology, such as biosimilar Cell and Gene Therapy Products (CGTPs)

Generics

A generic product is nearly identical to an already registered product in Malaysia. We can divide it into two categories.

  • Products containing poisons specified in the First Schedule of the Poisons Act of 1952 are considered Scheduled Poisons (also known as Controlled Medicine or Controlled Poison).
  • Non-scheduled Poison (also referred to as Non-Poison or Over-the-Counter) Products containing active ingredients that we do not include in the first schedule under the Poisons Act of 1952.

Criteria for registering pharmaceutical products in Malaysia

Products you need to register in Malaysia must meet the registration criteria established by the Drug Control Authority (DCA) for the product’s safety, quality, and efficacy.

The following parameters are necessary to consider:

  • The demand for the item
  • Risk of abuse
  • The number of products that have already been registered.
  • Dosage
  • Therapeutic outcome

Registration requirements for pharmaceutical products in Malaysia

International

  • WHO, ICH, EMA, US-FDA

Regional 

  • ASEAN Guidelines for Stability Process validation Variation

Local 

  • Drug registration guidance document 
  • NPRA guidelines 
  • DCA directives circulars

GMP specifications

  • PIC’s (PIC, or Pharmaceuticals Inspection Cooperation Scheme) standards.
  • All manufacturers should be able to obtain GMP certification if more than one manufacturer is involved.

The procedure for new drugs and biologics registration in Malaysia

  1. You have to apply online through the QUEST3 system. QUEST online membership registration allows users to conduct secure online activities for product registration applications.
    • Application for Registration as a Quest3+ Member
    • Getting a USB token that includes a user digital certificate
    • Application access to the QUEST online system for product registration 
  2. The National Pharmaceutical Regulatory Agency’s (NPRA) initial review is to make sure that the application contains all the required facts and information.
  3. Next, you have to make a sample submission for laboratory analysis. The applicant has 14 working days to deliver samples for laboratory testing from the date of screening approval. They will reject the application if the applicant fails to submit the sample within the allotted time frame.
  4. Applications with the supplied data are evaluated based on various claim levels and product categories.
    • If the Authority determines that more supporting data, information, or documentation is required, it will notify the applicant via the system.
    • If the applicant does not reply to the NPRA’s letter within six (6) months of the date of the initial correspondence, the application will be rejected.
  5. The evaluator conducts a review after the technical evaluation and communication with the applicant.
  6. Following the evaluation, the final report is provided to the Drug Control Authority (DCA) by the NRPA evaluation committee.
  7. Finally, the owner of the product registration may receive a regulatory decision via official letter or email. The Authority may reject, cancel, or suspend the registration at any time if there are issues with the product’s efficacy, quality, or safety or if the registration requirements are unsatisfactory.
  8. The registration status is valid for five (5) years or until it expires. The applicant must follow all obligations and specifications outlined during the approval process after receiving approval.

The procedure for generic drug registration in Malaysia

The following are the main requirements for the generic drug product registration process.

The objective is to complement and facilitate the goals of AFTA, especially the removal of technical trade barriers posed by regulations of the ASEAN member countries.Consultative Committee for Standards and Quality’s

  • Pharmaceutical Product Working Group (PPWG-ACCSQ)
  • Common Technical Dossier/Requirements (ACTD/ACTR) 
  • Technical Documents—Process Validation, Analytical Validation, Stability, BA/BE

Click here for additional information on the registration process of a generic drug in Malaysia

Timeline for the registration process

Type of pharmaceuticalTimeline
New drugs and biologics245 working days
Scheduled & Non-Scheduled Poison generic drugs210 working days
Generic drugs – Non-Scheduled Poison• Single active ingredient • Two or more active ingredients
116 working days136 working days

Pricing

The MOH is the biggest consumer of pharmaceuticals and indirectly manages and lowers drug prices through bulk purchases.

In the private sector, there are no mechanisms for price control. Without pricing guidelines or restrictions, producers, distributors, and retailers can make any prices they like on the open market.

However, as a public resource for purchasing medications in the private sector, the MOH has produced and maintained a Consumer Price Guide (CPG) under the Pharmaceutical Services Programme (PSP). Intending to direct pharmaceutical price policy and enhance accessibility and affordability of medicine in Malaysia.

What are the approximate fees for each authorization?

Category of productprocessing feeslaboratory feesCertifications feecharges for product classification
New drug productsRM 1000,00RM 4000,00RM 50,00 (valid for two years)RM 300 per product

How long are marketing authorizations valid and how are marketing authorizations renewed?

  • A drug’s marketing registration is valid for five years, whichever comes first, or for the period noted in the registration certificate.
  • One can renew the product registration no later than six months before the expiration date.
  • You can make updates to the product’s details, modifications, and variations using a suitable application. 
  • A new registration is necessary if the changes to a registered product impact its efficacy, safety, or quality.

Are there differences between local manufacturers and foreign-owned manufacturers?

Local manufacturers must guarantee their products’ essential safety and performance principles (EPSP) and GMP compliance. 

Application for registration of drugs is necessary from both domestic and foreign manufacturers. The following steps are involved in the registration of medical equipment made by overseas manufacturers:

  1. To register their drug, a foreign manufacturer must designate an Authorized Representative (AR). 
  2. AR must create the Common Submission Dossier Template (CSDT) based on the technical data from the foreign manufacturer to be submitted to the MDA.
  3. The same registration application dossier should be reviewed by an independent CAB (different from the one used by the foreign manufacturer in other nations), who will issue a CAB certificate. 
  4. MDA will then review the CAB certificate and decide whether to approve or reject the drug under the registration name of the AR.

How is compliance with regulations monitored and evaluated in Malaysia?

The NPRA keeps an eye on adherence to drug laws. Any pharmacy or anyone conducting business in Malaysia producing, wholesaling, and importing medications should obtain the necessary licenses from the NPRA.


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