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Nutraceutical Regulation in Malaysia


Nutraceutical Regulation in Malaysia

In Malaysia, ethnic diversity with its traditional medicine practices has been instrumental in nutraceutical development. The country also boasts of rich biodiversity This sheer abundance of raw materials gives Malaysia a competitive edge against global counterparts in the development of nutraceuticals. Nutraceutical products are closely related to the herbal industry, which was identified as a new source of economic growth in 2011 under the Agriculture New Key Economic Areas (NKEA). With potential GDP contributions of ranging from RM19 billion to RM28 billion by 2027, This is illustrated by the increase in natural product registration. According to the National Pharmaceutical Regulatory Agency (NPRA), more than 50 percent of the total products registered in 2019 were natural products equivalent to 12,139 units. The Malaysia Nutraceuticals Market is projected to reach USD 1382.3 million by 2027 from 794.4 million in 2020.


  • Nutraceutical product regulation in Malaysia

The Ministry of Health Malaysia (MOH) plays a pivotal role in overseeing the regulation of nutraceuticals and ensuring public health and safety. The MOH is the primary regulatory authority responsible for overseeing and enforcing regulations related to nutraceuticals and other health-related products. It sets the standards, guidelines, and policies governing the production, importation, distribution, and sale of nutraceuticals in Malaysia. The key regulations and guidelines include,

  • Food Act 1983: Under this act, nutraceuticals are considered food products. It outlines the standards and requirements for their production, import, sale, and labeling

  • Food (Amendment) Regulations 2010: These regulations provide specific guidelines for the registration, labeling, and advertising of food products, including nutraceuticals


  • Nutraceutical product registration in Malaysia

1. Preparing Documentation:


Product Dossier: Prepare a comprehensive product dossier, including information on the product's formulation, safety data, efficacy studies, and quality control measures.

Good Manufacturing Practices (GMP) Certificate: Ensure that the manufacturing facility complies with GMP standards.

Product Samples: Submit samples of the nutraceutical for testing and analysis.


2. Application Submission:


Submit the completed registration application along with the required documents to the MOH's Food Safety and Quality Division.


3. Document Evaluation:

The MOH will review the submitted documents for compliance with safety and quality standards.


4. Approval:

If the product meets all requirements and is deemed safe and effective, the MOH will grant approval for its sale and distribution in Malaysia.


  • Documents Required for Nutraceutical Registration in Malaysia:

1. Product Formulation and Composition.

2. Safety Assessment.

3. Efficacy Studies (if applicable).

4. Quality Control Measures.

5. GMP Certificate.

6. Product Samples.

7. Product Label Design.

8. Declaration of Halal Compliance (if applicable)


  • Health supplement Labeling Requirements in Malaysia:

The labeling of nutraceuticals in Malaysia must adhere to specific guidelines:


  • Clear product name and brand.

  • Ingredients list with specified quantities.

  • Nutritional information, including serving size and per-serving nutrient values.

  • Recommended usage instructions.

  • Any contraindications or warnings.

  • Batch number and expiry date.

  • Halal certification logo (if applicable).

  • Health claims must be scientifically substantiated and approved by the MOH.

  • Timeline and Fees associated with nutraceutical regulation in Malaysia.


- Timeline: It may take 116 to 136 working days from the submission of the application to approval.

- Fees involved in health supplement regulation in Malaysia.



​Product

Processing

fees (RM)

​Analysis fee (RM)

Total fees (RMA)

Health supplement

1000

​1200- 2000

2200-3000


  • Nutraceutical product registration outcome

Upon a positive evaluation, the Ministry of Health (MOH) bestows a registration number known as the MAL number, valid for 5 years. Approved applicants must adhere to stipulated conditions and ensure ongoing product quality, safety, and efficacy throughout the registration's validity. To secure re-registration, applicants must initiate the process within six months before expiration, involving the submission of the Re-registration Application Form and payment of a processing fee. Failure to do so necessitates a new registration.


In the event of rejection, a window of 14 days from the Authority's notification allows applicants to appeal to the MOH. Re-submission after rejection is prohibited for 2 years. However, if the product holds registration in reference countries, applicants may apply sooner. This system safeguards product integrity and public health, fostering a commitment to adherence, accountability, and transparency within the nutraceutical industry in Malaysia.



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