In Malaysia, there is a distinction between "foods", which are regulated by the Food Safety and Quality Division of the Ministry of Health Malaysia ("FSQD"), and "drugs", which are regulated by National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health Malaysia ("NPCB"). The regulation of food quality and integrity in Malaysia is governed primarily by the Food Act 1983 ("Act") and its subsidiary legislation, the most pertinent of which is the Food Regulations 1985 ("Regulations").
However, it may sometimes be difficult to determine whether a product is a "food" or a "drug". Such products are termed as 'Food-Drug Interface (FDI) products. In order to better define and regulate the FDI products, both the NPRA and the FSQD, the Ministry of Health Malaysia formed the Committee for the Classification of Food-Drug Interphase Products in 2000.
Before the submission of application for a food product registration in Malaysia, applicants may have to submit an application for product classification if unsure of product category. Freyr with a clear-cut knowledge on Malaysia Regulatory framework assists manufacturers with the end-to-end food product registration, and classification.
- Product Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Compilation, Gap Analysis and Submission of Dossier to Health Authority (NPRA)
- Legal Representation
- Local Labeling Support and Label Design support
- Translation Support
- Regulatory Intelligence Report
End-to-end Regulatory consultation for Malaysia
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc
Support for region-specific Regulatory activities
Extensive partner network across the globe
Strong relationship with different health authorities
Structured and cost-effective approach to ensure speed to market for the products