The Safety of Herbal Medicinal Products

by Sevda Hubanova Yoztyurk, Pharmacovigilance Scientist & QPPV Office Co-ordinator at Panacea

Herbal medicines are derived from plants and are often perceived as natural or safe alternatives to conventional drugs. However, like any other medicinal product, they can also have potential risks and adverse effects.

Pharmacovigilance activities play an essential role in monitoring the safety of herbal medicines.

Regulations regarding the safety of herbal medicines can vary across different countries. Below is a general overview of some common regulatory approaches that are implemented to ensure the safety of herbal medicines;

  • Registration and approval
  • Good Manufacturing Practices (GMP)
  • Labelling requirements
  • Adverse event reporting
  • Herbal monographs and Pharmacopoeial standards
  • Traditional medicine regulations

In Europe, the regulation of herbal medicines is primarily governed by the EU legislation. The main regulatory framework for herbal medicines in the EU is the Directive 2004/24/EC, commonly known as the Traditional Herbal Medicines Products Directive (THMPD). Herbal medicines intended for sale in Europe must undergo a registration process under the THMPD. The registration process allows herbal medicines with well established traditional use and favourable safety profiles to be registered and marketed without the need for full pharmaceutical-style clinical trials. However, applicants must provide scientific evidence to demonstrate the traditional use of the herbal medicine for at least 30 years, including 15 years within the EU.

Also, herbal medicines must meet specific quality and safety requirements. The manufacturing process should include appropriate extraction methods, analysis of active ingredients, control of contaminants and stability testing according to GMP guidelines. The product’s composition, specifications of actives, manufacturing process and all the data should have comprehensive documentation. Herbal medicines must have clear and accurate labelling and packaging, which includes product name, dosage instructions, list of actives, indications and also warnings and precautions. Packaging also should ensure stability and protection of the product.

The European Medicines Agency (EMA) and the European Pharmacopoeia (Ph. Eur.) provide monographs for herbal medicines which includes, quality, identity and specification references.

Adulteration in herbal medicines

This refers to the intentional or unintentional contamination (heavy metals, pesticides, pathogens, mycotoxins), substitution (imitation effects or appearance, reduce costs) or dilution (adding filler ingredients or lower quantities prevents to achieve the effect) of the products with unauthorised substances or inferior quality ingredients. Adulteration can occur in any stage from sourcing the raw materials to the final product, and is a significant concern in the herbal medicine industry.  Regulatory authorities, such as the EMA, the U.S. Food and Drug Administration (FDA), and other national regulatory agencies, have established guidelines, standards, and testing methods to detect and prevent adulteration in herbal medicines. Good manufacturing practices (GMP) and regular quality control testing are essential to ensure the authenticity, purity, and safety of herbal products. Consumers should choose reputable manufacturers and consult healthcare professionals for guidance on the appropriate use of herbal medicines.

Importance of nomenclature

The nomenclature of herbals, refers to the standardized naming and classification of herbal medicines and is important for several reasons:

  • Identification and Authentication: Proper nomenclature helps in accurately identifying and authenticating herbal medicines. Many herbal medicines are derived from multiple plant species or have different varieties, and having a standardized nomenclature ensures that the correct plant species or variety is used in the preparation of herbal medicines. This is crucial for ensuring consistent quality, efficacy, and safety of herbal products.
  • Quality Control and Standardisation: Nomenclature plays a crucial role in quality control and standardisation of herbal medicines. By using standardised scientific names for herbs, it becomes easier to establish and maintain consistent quality standards for the raw materials used in herbal products. This helps in ensuring that the active ingredients and chemical constituents of the herbal medicines are consistent, facilitating reproducibility and reliability in their efficacy and safety.
  • Communication and Documentation: Consistent nomenclature enables effective communication and documentation among researchers, manufacturers, regulatory authorities, healthcare professionals, and consumers. It provides a common language for discussing and referring to specific herbs, allowing accurate exchange of information about their properties, uses, safety concerns, and interactions. It also aids in research, clinical studies, and pharmacovigilance activities related to herbal medicines.
  • Pharmacological and Phytochemical Studies: The nomenclature of herbals is essential for conducting pharmacological and phytochemical studies. With standardized naming, researchers can easily refer to the correct plant species and ensure that the findings of their studies are applicable to the intended herb. This helps in building a reliable body of scientific knowledge about the therapeutic properties, mechanisms of action, and safety profiles of herbal medicines.
  • Regulatory Compliance: Proper nomenclature is often a requirement for regulatory compliance in the manufacturing and marketing of herbal medicines. Regulatory authorities, such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other national regulatory agencies, may have specific guidelines regarding the nomenclature and labelling of herbal medicines. Compliance with these guidelines ensures that herbal products meet the necessary regulatory standards for safety, efficacy, and quality.

In summary, the nomenclature of herbals is important in “herbal medicines pharmacovigilance” as it aids in identification, quality control, standardization, communication, documentation, scientific research, and regulatory compliance. Standardized nomenclature ensures that herbal medicines are properly identified, authenticated, and characterized, contributing to their overall safety, efficacy, and appropriate use.

As described above regulating herbal medicines can be challenging, mostly due to a lack of standardisation, complexity of ingredients, traditional practices, limited scientific data, consumer freedom of choice and also political and economical factors. As scientific understanding of herbal medicines advances, regulatory frameworks need to adapt, keeping regulations up to date with the latest research findings can be a continuous challenge. Also, the other challenge is that herbal products can be easily marketed as nutritional supplements, which don’t go through the same regulation path. Despite these challenges regulatory bodies are increasingly collaborating on an international level to harmonize guidelines and standards for herbal products. This will require a lot of changes to processes for safety scientists in the near future.