PHYTOPHARMACEUTICAL AND REGULATORY REQUIREMENT
Globally, herbal medicine has been considered an important alternative to modern allopathic medicine.
Although the herbal medicines are very popular in the society, only few medicinal herbs have been scientifically evaluated for their potential in medical treatment. In most countries, the herbal drugs are poorly regulated and are often neither registered nor controlled by the health authorities.
The safety of herbal medicines remains a major concern. In the United States, the Food and Drug Administration (FDA) has estimated that over 50,000 adverse events are caused by botanical and other dietary supplements.[ 1] In addition, for most herbal drugs, the efficacy is not proved and the quality is not assured.
The World Health Organization’s (WHO) Traditional Medicine (TM) Strategy 2014–2023 focuses on promoting the safety, efficacy, and quality of TM by expanding the knowledge base and providing guidance on regulatory and quality assurance standards.[2]
Herbal medicine products include herbs, herbal materials, herbal preparations, and finished herbal products that contain parts of plants, other plant materials, or combinations thereof as active ingredients.[3] Herbs include crude plant material, for example, leaves, flowers, fruit, seed, and stems.
Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins, and dry powders of herbs.
Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures, and fatty oils of herbal materials. Finished herbal products consist of herbal preparations made from one or more herbs.
The regulation regarding herbal preparations varies from country to country.[4] Globally, several diverse regulatory approaches are such as:
Same regulatory requirements for all products, same regulatory requirements for all products, with certain types of evidence not required for herbal medicines, exemption from all regulatory requirements for herbal medicines, exemption from all regulatory requirements for herbal medicines concerning registration or marketing authorization, herbal medicines subject to all regulatory requirements, herbal medicines subject to regulatory requirements concerning registration or marketing authorization.
In Europe, for the marketing approval, [5] the herbal preparations are classified in three categories as follows:
– Traditional medicinal use provisions , accepted on the basis of sufficient safety data and plausible efficacy
– Well-established medicinal use provisions ,demonstrated with the provision of scientific literature establishing that the active substances of the medicinal products have been in well-established medicinal use within the European Union for at least 10 years, with recognized efficacy and an acceptable level of safety a product can be classified under.
– Safety and efficacy data from the company’s own developmentstand alone or a combination of own studies and bibliographic data mixed application.
FDA Botanical Drug Development Guidance [6] describes appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs).
The term botanical means products that include plant materials, algae, macroscopic fungi, and combinations thereof. FDA guidance recommends that IND must contain sufficient information to demonstrate that the drug is safe for testing in humans and that the clinical protocol is properly designed for its intended objectives.
In addition to general regulatory requirements for an NDA – nonclinical pharmacology/ toxicology studies, clinical evidence of efficacy and safety – for botanical drugs there are special requirements to ensure safety and quality of botanicals [6] as follows:
• Description of product and documentation of prior human experience:
-Description of botanical raw materials used and known active constituents or chemical constituents.
-Prior human experience
• Quality control:
-Botanical raw materials.
-Botanical drug substance and drug product
• Identity, chemical characterization, manufacturing processes, biological assay, specifications, stability, current good manufacturing practices, and environmental assessment.
• Evidence to ensure therapeutic consistency:
-Botanical raw material control.
-Quality control by chemical test(s) and manufacturing control.
-Biological assay.
-Clinical data: Dose-response data and multiple batch clinical data.
The new phytopharmaceuticals regulation permits the development of the drug development using advanced techniques of solvent extraction, fractionation, potentiating steps, modern formulation development, etc. [7] The new regulations for phytopharmaceuticals must in line with regulations in USA, China, and other countries.
[7] This new regulation is expected to promote innovations and development of new drugs from botanicals in a scientific way and would help in the accept- ance of the use of herbal products by modern medical profession.
It would en- courage research in phytopharmaceutical drug development for academia, researchers, and industry. [8]
Gülşah Gedik Dr. Öğr. Üyesi /Assist. Prof. Phd. Trakya Üniversitesi / Trakya University Eczacılık Fakültesi / Faculty of Pharmacy Farmasötik Teknoloji Anabilim Dalı Department of Pharmaceutical Technology
