Strategic Regulatory Partner for Success in Malaysia

Greetings from

Pharma Wizard Malaysia

Pharma Wizard is a global Regulatory leader providing services and solutions to Life Sciences companies across their entire Regulatory value chain. With our presence in 120+ countries, we help Life Sciences companies in their “local to global” journey.
At Pharma Wizard Malaysia, we support companies with drug product registration in Malaysia, Regulatory strategy, market intelligence, in-country representation, Post-Market Surveillance (PMS) functions, and more. We also offer next-gen Regulatory software solutions covering the complete NPRA (National Pharmaceutical Regulatory Agency) registration life cycle.

Industries We Serve in Malaysia

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 to ensure that all drugs adhere to the drug registration guidelines in Malaysia.

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

vering the complete NPRA registration life cycle.

Malaysia provides one of the strong and powerful market for the foreign Medical Device manufacturers in the Southeast Asia. Medical Device Authority (MDA) as a part of Ministry of Health (MoH) regulates all Medical Device in Malaysia. Before marketing any device in Malaysia, it should be registered with Malaysian Medical Device Authority (MDA). Foreign manufacturers must appoint a Malaysia Authorized Representative for the purpose of Medical Device Registration in Malaysia

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

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

FBR

Company Profile

Portfolio

Presentation

Order

Food & Food Supplements Product Services

Categories Supported

Sustainability Services