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Pharmaceuticals Expertise

  • End-to-End Registration Support 
  • Authorized Local Agent Support 
  • Manufacturing Site Approval Support
  • Import Registration Support
  • Sample Import License Support
  • Regulatory Affairs Consulting
  • Pharmaceutical Dossier Preparation and Submission to the NPRA
  • Query Support Management till Approval
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Overview of the Malaysian
Regulatory Landscape

Under the Ministry of Health (MoH) Malaysia, and along with other Member Authorities, the National Pharmaceutical Regulatory Agency (NPRA) regulates the life science industry in Malaysia. Medicinal products in Malaysia are regulated by the Drug Control Authority (DCA) and Medical Device Authority (MDA) is the Agency that controls and regulates the medical device registration. DCA was formed under the Drugs and Cosmetics Regulations (CDCR) 1984 from the Sale of Drugs Act 1952. DCA is the stakeholder for quality control activities, licensing, and post-registration activities. The NPRA carries out scientific and technical reviews, inspections, and surveillance activities of the medicines. 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 PIC/S.

 

Industries We Serve

Medicinal products in Malaysia are regulated by the Drug Control Authority (DCA). The DCA was formed under the Drugs and Cosmetics Regulations (CDCR) 1984 from the Sale of Drugs Act 1952. DCA is the stake holder for quality control activities, licensing and post-registration activities. The National Pharmaceutical Regulatory Agency (NPRA) carries out scientific and technical reviews, inspections and surveillance activities of the medicines.

  • End-to-end Registration Support
  • Authorized Local Agent Support
  • Manufacturing Site Approval Support
  • Import Registration Support.
  • Regulatory Affairs Consulting
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Medical Product

Malaysian Medical Device Authority (MDA) is the Agency that controls and regulates the medical device registration. MDA was established under the Medical Authority Act 737, 2012. MDA uses a centralized online application system called MedCast for submissions related to Medical Devices. The Conformity Assessment Body (CAB) carries out the technical data evaluation under the authorization of the MDA.

  • Authorized Local Representation
  • End-to-end Medical Device Registration with the MDA
  • Regulatory Intelligence & Solutions
  • Preclinical Services - Generation of Scientific Report for Regulatory Submissions
  • MDA Establishment License Application
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Medical Device

In Malaysia, health/food supplements with general and functional claims are regulated under the category of medicinal products requiring registration and approval from the National Pharmaceutical Regulatory Agency (NPRA). A Health supplement is a product used to supplement a diet and to maintain, enhance and improve the health function of the human body.

  • Food Product Classification
  • Formula Review/Ingredients Assessment
  • Food Label and Claims Review
  • Compliance as per New labeling Regulation
  • Claims Consultation and Substantiation
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Food and Food Supplements

Current import trends depict a growing curve for cosmetic products in Malaysia. All cosmetic products, which are intended to be marketed and distributed in the local market are required to be notified with the National Pharmaceutical Regulatory Agency (NPRA) Malaysia, formerly known as the National Pharmaceutical Control Bureau (NPCB).

  • Product Classification
  • Cosmetics Notification Holding
  • Formulation/Ingredient Analysis
  • Claims Review
  • Label Review
  • Cosmetic Notification in Malaysia with the NPRA
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Cosmetics

About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

Location

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

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