Health Ministry approves the first natural products with therapeutic claims, says Health DG

PETALING JAYA: The Health Ministry Approves First Registration of Natural Products with Therapeutic Claims

In a significant milestone, the Health Ministry has granted approval for the first registration of natural products with therapeutic claims. Datuk Dr Muhammad Radzi Abu Hassan, the Health director-general, announced that this decision was made during the 386th Drug Control Authority Meeting held on July 6. This move signifies the increased regulation of natural products within the country.

Dr Muhammad Radzi emphasized that therapeutic claims for natural products are claims that go beyond the traditional uses and specifications outlined in the pharmacopoeia/monograph. He stated, “These claims must be supported by scientific evidence to ensure their validity and effectiveness,” during a statement released on Saturday.

The registered natural product is none other than Fespixon cream, which is used for treating diabetic foot ulcers. It contains active ingredients such as Plectranthus amboinicus aerial extract (2.5mg/g or 0.25%w/w) and Centella asiatica herbal extract (10mg/g or 1%w/w). Manufactured by Oneness Biotech Co., Ltd., Nanchou plant, Taiwan, the registration for the product in Malaysia is held by Pharmeng Technology Sdn. Bhd.

In 2020, The National Pharmaceutical Regulatory Division (NPRA) released comprehensive guidelines outlining the necessary requirements for the registration of natural products with therapeutic claims. Dr Muhammad Radzi highlighted that companies seeking registration must provide extensive documentation and information regarding the quality, safety, and effectiveness of the product.

He further stated, “Additionally, scientific evidence from clinical studies on the finished product is required to support its safety and efficacy for the specific therapeutic claim.” In 2021, the NPRA also published the 7th edition of the Malaysian Guideline for Application of Clinical Trial Import License and Clinical Trial Exemption to guide the industry in complying with the regulatory requirements for research products used in clinical trials within Malaysia.

This registration of natural products not only provides opportunities for local operators in the natural product industry but also encourages them to conduct their own clinical studies and gather scientific evidence for future registration applications. Dr Muhammad Radzi assured that the NPRA will continue to oversee the quality, safety, and effectiveness of registered products, ensuring the well-being of consumers.