CONTROL OF DIETARY SUPPLEMENTS IN MALAYSIA. TAN LIE SIE DRUG EVALUATION AND SAFETY DIVISION NATIONAL PHARMACEUTICAL CONTROL BUREAU MINISTRY OF HEALTH MALAYSIA. Seminar on dietary supplements - 15 January 2004. CONTENTS. Food / Drug Interface Regulatory Process in Malaysia Concerns
TAN LIE SIE
DRUG EVALUATION AND SAFETY DIVISION
NATIONAL PHARMACEUTICAL CONTROL BUREAU
MINISTRY OF HEALTH MALAYSIA
Seminar on dietary supplements - 15 January 2004
(Guide to determining if a product is to be regulated by the NPCB/FQC)
Pure Form of active ingredient (singly or in combination)
Natural product that are not traditionally used as food and of medicinal value
Less than 80% food base or more than 20% active ingredients of natural products. But if the latter possess high potencies, the product shall be reviewed by the Committee, even if they contain less than 20% of these ingredients.
80% or more Food base
NPCB-National Pharmaceutical Control Bureau
FQC – Food Quality Control Division
contains pure forms of active ingredient (e.g.: vitamins & minerals) that exceed the amounts permitted in Food Regulations 1985,
the company shall be advised to reduce the
amounts of these active ingredients and be
regulated by BKMM.
Following criteria should not be used as
sole criteria for classification but can be
used as a guide
CONTROL BUREAU (NPCB)
(as Secretariat / Executive Arm)
Regulation 7(1)(a) requires ALL products to be registered with the DCA prior to being imported, manufactured, sold or supplied, unless the product is exempted under specific provisions of these Regulations.
A “product”as defined in the Regulations, means “a drug in a pharmaceutical dosage form, or a cosmetic, having a singular
identity, composition, characteristics and origin”.
A drug is used on humans (and animals)
Need to protect consumer interests
* Record of products registered and their respective responsible market authoriztion holders and manufacturers
* Monitoring and enforcement
* Regulate claims
* Safety aspects
- infrastructure /facilities
- processes and controls
- raw materials
- finished product
- stability testing
CLAIMS ( EFFICACY )
On-line registration process (single stage)
Implementation of the on-line registration system :
Quality test for traditional products
JKPPFlow Chart of Registration Process (Pre-market Approval)
Obtain smart card
Input data & submit
BPFK evaluate application
Request for additional info
Prepare evaluation report
Request for additional info
- Although a product may not be toxic or dangerous, consumers may compromise their health by not seeking proper medical attention.
- Claims about supplements should not divert attention away from eating a healthy diet
There is tremendous interest in and demand for health supplements and a need for regulators to accommodate both the industry and consumers in this area.
However the growing market for supplements in a less restrictive regulatory environment creates the potential for supplements to be prone to quality-control problems
Authority to regulate and approve product registration and licensing through pre-market assessment helps ensure that consumers have access to safe, high quality, properly labeled products.