DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)1.3 FOOD - DRUG - INTERFACE PRODUCTSThis guide serves to assist in determining if a product is to be regulated by the NationalPharmaceutical Control Bureau (NPCB) or the Food Safety and Quality Division (FSQD)of the Ministry of Health Malaysia.1.3.1 INTRODUCTIONMalaysians are now more health conscious and there is generally greater awareness ofthe importance of the nutrition to overall well-being. In recent years, many consumersalso rely on a variety of “dietary supplements” to improve their health. These diverseproducts are freely available through a myriad of outlets. A variety of products areavailable in the market, supposedly for the maintenance, prevention and even treatmentof chronic diseases. These products may range from foods modified to have specialproperties or pure forms of vitamins and minerals to extract of various botanical oranimal products.It is important to monitor and regulate the marketing and sale of these products so as toprotect the interest of the consumer. Some of these products are not clearly marketedas “food” or “drugs”. These have been termed as “food-drug interface (FDI) products”and include a variety of so-called health products.Previously, it had been difficult to determine which authority within the Ministry of HealthMalaysia should regulate the marketing and sale of such products, either FSQD orNPCB. This has caused difficulty to the companies intending to market such products. Itis also not beneficial to the consumer as the products could be in the market and notregulated by either of the authorities.To overcome these problems and to enable a decision to be made as to which authorityshould regulate a particular product, the Committee for the Classification of Food-DrugInterface Products has been formed since year 2000. The main terms of reference ofthe Committee is to assist the FSQD and NPCB in classifying, in a consistent manner,an application from the industry which is not clearly defined as a food or drug productthat is a FDI product. Other duties include advising the two divisions of the Ministry ofHealth in strengthening and updating the relevant regulations as well as to providescientific input on these products.National Pharmaceutical Control BureauFirst Edition, January 201337