PETALING JAYA: The Health Ministry has approved the first registration of natural products with therapeutic claims, says Datuk Dr Muhammad Radzi Abu Hassan.
The Health director-general said the decision made through the 386th Drug Control Authority Meeting (PBKD) held on July 6 marks a significant milestone in the regulation of natural products in the country.
"Therapeutic claims for natural products refer to claims that are not specified in the pharmacopoeia/monograph or traditional uses of the herb's active ingredient.
"These claims must be backed by scientific evidence to ensure their validity and efficacy," he said in a statement on Saturday (July 8).
The natural product that has been granted with the registration was Fespixon cream, used for the treatment of diabetic foot ulcers.
The cream contains Plectranthus amboinicus aerial extract (2.5mg/g or 0.25%w/w) and Centella asiatica herbal extract (10mg/g or 1%w/w) as active ingredients.
Manufactured by Oneness Biotech Co., Ltd., Nanchou plant, Taiwan, the product's registration in Malaysia is held by Pharmeng Technology Sdn. Bhd.
Dr Muhammad Radzi said that a comprehensive framework outlining the necessary requirements for the registration of natural products with therapeutic claims has been released through the Guidelines on Natural Products with Therapeutic Claims by The National Pharmaceutical Regulatory Division (NPRA) in 2020.
"To obtain registration, companies must provide documents and information regarding the quality, safety, and effectiveness of the product.
"Furthermore, scientific evidence from clinical studies on the finished product is required to support its safety and efficacy for the specific therapeutic claim," he added.
The NPRA has also published the 7th edition of the Malaysian Guideline for Application of Clinical Trial Import License and Clinical Trial Exemption in 2021 as a guide to the industry regarding the regulatory requirements of research products used in clinical trials in Malaysia.
He also said that with the registration of the products, it will encourage local operators in the natural product industry to conduct clinical studies and gather scientific evidence for future registration applications.
"The NPRA will continue to oversee the quality, safety, and effectiveness of the registered products, ensuring the well-being of consumers," Dr Muhammad Radzi said.
