Herbal Medicine: Regulation and Marketing
- Author:
Noel L. Espallardo
;
Jona G. Manalili
- Publication Type:Other Types
- Keywords:
Efficacy;
Quality
- MeSH:
Herbal Medicine;
Safety
- From:
The Filipino Family Physician
2019;57(1):65-68
- CountryPhilippines
- Language:English
-
Abstract:
Given the expansion of herbal medicine, the overall quality, safety and efficacy must be subjected to critical examination if the intention is to safeguard public health. There are quality concerns on the products already in the market. Adulteration of contents, ingredients differing from label and unsupported or misleading claims are reported in several studies. This article proposes three areas that can be standardized to ensure quality, safety and efficacy of herbal medicines. The first is ensuring good agriculture and harvesting practices for the plant raw materials. Second is good manufacturing practice of producing medicinal preparation (liquid or solid form) from the raw materials. Third, develop a standardized and acceptable clinical trial design to demonstrate safety and efficacy. The regulatory agencies of some developed countries have published guidelines to ensure the quality of herbal medicines. Example of these guidelines are the botanical drug product guidance of the US FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products by the EMA. They specify different registration pathways. Registration pathways in Europe are traditional herbal registration (THR) or conventional marketing authorization (CMA). In the USA, it can be registered as dietary supplement (DS) or botanical drug (BD). In the Philippines herbal medicines taken orally can be registered as herbal medicine (HM), traditional use herbal product (TUHP) and dietary supplement (DS). Requirements for registration in the three regions compared include quality control and good manufacturing practices, evidence of safety and toxicologic studies and evidence of efficacy or clinical trials, but it all depends on the product to be registered or the chosen pathway for registration. After approval for marketing, there must be a methodological approach for post-marketing safety based on sales data and information on adverse drug reactions of newly introduced herbal medicinal products in the market.
- Full text:PAFP-Journal-2019-1-69-72.pdf
