PUTRAJAYA: The implementation of natural products based on the Guideline on Natural Products with Modern Claim has been approved to strengthen the regulatory system for natural products in Malaysia, and took effect from April 4.
In a statement today, the Ministry of Health (MOH) said the matter was approved at the 395th Drug Control Authority meeting (PBKD) which took place on the same day (April 4).
“The implementation of this registration is a holistic step by the Health Ministry to strengthen the regulatory system for natural products in Malaysia,“ said the statement.
According to the MOH, the registration of natural products or traditional medicines began in1992.
It said the claims allowed for natural products were initially for traditional uses such as for general health care and relief of mild symptoms, based on traditional usage information for the products.
In June 2020, the National Pharmaceutical Regulatory Agenct (NPRA) issued another guideline for the registration of natural products, namely the Guideline on Natural Products with Therapeutic Claim to allow the registration of natural products with therapeutic claims.
“Applications for the registration of natural products with therapeutic claims to treat diseases must be accompanied by evidence of the effectiveness and safety of the product based on clinical studies to support the application,“ it said.
The MOH said that nowadays, research on plant or herbal products to be commercialised is growing.
It said there is new information and data that can support the use of natural products to control the symptoms of more specific diseases as well as for uses other than traditional use.
“However, based on the existing guidelines, such natural products can only be registered under the traditional product category because they do not have enough clinical study evidence to make therapeutic claims.
Therefore, the MOH said there is a need to create another category of intermediate natural products with modern claim.
Modern claims refer to claims made based on scientific evidence to improve health, reduce the risk of disease or help treat disease symptoms.
Scientific studies to validate modern claims need to show a link between product formulation and health effects whereas the level of claims allowed for modern claims does not exceed the level of claims allowed for therapeutic claims.
The guidelines describe in details the types of evidence or references that are acceptable to support the registration of natural products with modern claims.
Therefore, the MOH is committed to efforts to improve Malaysians’ access to quality, safe and effective medicines.
The production of these guidelines is expected to encourage more local natural product operators and researchers to conduct related studies and subsequently submit scientific evidence to support registration applications.
“MOH, through NPRA, will continue to monitor the quality, safety and effectiveness of the products that have been registered,“ it added.
