- Home
- >
- Malaysia
- >
- Nutrition
Nutrition Industry: Regulatory Consulting in Malaysia
Artixio offers expert consulting services tailored to the Malaysia nutrition industry, guiding global growth with local insights.
Regulatory Procedure of Nutritional Industry in Malaysia
Although the registration and licensing process for nutraceuticals is simple in Malaysia, one must be aware of the required documentation and the steps involved in registering their products. The market for food supplements and nutraceuticals in Malaysia seems to be quite promising.
Under the Ministry of Health (MOH), the National Pharmaceutical Regulatory Agency (NPRA) is the regulatory body in Malaysia in charge of registering and overseeing nutraceutical goods. To guarantee safety, efficacy, and quality, the NPRA makes sure that these items adhere to all applicable laws and guidelines.
In several countries, including Malaysia, it is common for nutraceutical products to have a local distributor or agent who can help with local law compliance, regulatory procedures, and communication with authorities. On behalf of the foreign manufacturer, this local agent can also be extremely important in post-market surveillance and liaison with regulatory authorities.
In Malaysia, “foods” are governed by the Food Safety and Quality Division (FSQD) of the Ministry of Health (MoH), whereas “drugs” are governed by the National Pharmaceutical Regulatory Agency (NPRA) Malaysia. Nonetheless, it can occasionally be challenging to decide if a product belongs in the “food” or “drug” category. Malaysian food regulations refer to such uncertain items as “Food-Drug Interfase (FDI)” products. The Committee for the Classification of Food-Drug Interphase Products was established by the Ministry of Health Malaysia in 2000 to further define and regulate the FDI products, both the NPRA and the FSQD.
Generally, FDI products are products with combination of active ingredients and food ingredients which are consumed orally. Examples of food ingredients are vegetables, fruit, poultry, meat, milk, cereal and cocoa. Examples of active ingredients are minerals, vitamins, enzymes, herbs, peptides, probiotics, prebiotics, collagen, amino acids, fatty acids, astaxanthin, chia seed, and other ingredients that are not traditionally consumed as food. FDI products may be presented in the form of liquid, powder, semisolid forms such as jelly/gel, drops, granule, chewable tablet, etc.
Food Product Registration in Malaysia
Before the manufacturer may submit an application for food product registration in Malaysia, they might need to apply for product classification. Artixio, with its expertise, can help them with food product registration and classification if they are unsure of which product category to use.
Artixio Services for the Nutrition Market of Malaysia:
- Food Product Classification
- Formula Review/Ingredients Assessment
- Food Label and Claims Review
- Dossier Compilation and Gap Analysis
- Submission of Dossier to the NPRA Malaysia.
- Legal Representation (LR).
- Translation Support.
- Regulatory Intelligence (RI) Report.
- Post Approval Life Cycle Management.
Why Artixio
Excellent health authority relationships – with NPRA and FSQD.
Proven track record- Successful Approvals for 150+ Nutritional Products.
End to end Regulatory consultation from concept to commercialization.
Expert Regulatory team with 20+ years of expertise across all food categories in Malaysia.
Economical and Structured approach.
FAQs
1. What makes Artixio’s regulatory consulting services different from other providers in Malaysia?
Artixio stands out because of our comprehensive, personalized approach to food supplement regulatory consulting. We offer end-to-end support, from initial market assessment and product development to registration and post-market compliance. Our team of experienced regulatory specialists is well-versed in both local and international standards, ensuring that your product not only complies with Malaysian regulations but is also positioned for success in the global marketplace.
2. Can I amend the label/ formula of my product after it is registered?
Yes, at Artixio, we can assist you with the process of amending the label or formula of your registered product. Any changes to your product, whether it’s the label or formula, require prior approval from the NPRA before they can be implemented. We help you submit an application through the Quest online submission system. Please note, if the change involves altering the active ingredients, a new application must be submitted, as the formulation cannot be amended in such cases. We will guide you through the entire process and ensure all necessary approvals are secured for smooth and compliant product updates.
3. What are the common reasons for food supplement registration rejection by the NPRA, and how does Artixio help avoid them?
Common reasons for rejection include incomplete or incorrect documentation, non-compliance with labeling standards, unsubstantiated health claims, or the use of unauthorized ingredients. Artixio minimizes the risk of rejection by thoroughly reviewing all submission materials for accuracy and compliance with NPRA standards. We also provide guidance on acceptable health claims and ingredient approvals, ensuring your product meets all necessary criteria before submission.
4. How does Artixio ensure that the health claims on my product’s label are scientifically substantiated?
Artixio ensures that all health claims on your product’s label are supported by credible scientific evidence. Our regulatory team reviews the available clinical studies, research papers, and other evidence to ensure that the claims made on the product are substantiated, compliant with NPRA guidelines, and accurate. This helps mitigate the risk of misleading consumers or regulatory penalties.
5. Can a product already registered in another country, like the USFDA, be easily registered in Malaysia?
While prior approval from a regulatory body such as the USFDA may assist in some cases, Malaysian authorities require a separate registration process. The product will still need to undergo review by the National Pharmaceutical Regulatory Agency (NPRA), including submission of appropriate documents and safety data. However, having international approvals can streamline the process by providing additional credibility to the product’s safety and efficacy.
6. What are the key regulatory challenges when dealing with FDI in Malaysia?
Key challenges include navigating the dual classification of products (as both food and drugs), ensuring compliance with both food and pharmaceutical regulations, providing the necessary clinical and technical data to satisfy regulatory requirements, and managing the timelines for approval. Artixio with its expert regulatory consultancy support can help mitigate these challenges.
Regulatory Expertise Across Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
Blogs
In Vitro Diagnostics: Meaning,
The term “in vitro” is a Latin word that means “in glass”. Thus, from...
IVD Medical Devices Registration
The in vitro diagnostic in India is regulated by the Central Drugs Standard Control...
Pharma Manufacturing Booms in
Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with global market...