ISO/TR 23975:2019

Overview

ISO/TR 23975:2019 provides a comprehensive framework for the standardisation of single herbal medicines used in Traditional Chinese Medicine (TCM). This technical report establishes a priority list of these herbal medicines, facilitating the development of specific standards that ensure quality, safety, and efficacy. The standard is crucial for stakeholders involved in the herbal medicine sector, including manufacturers, regulatory bodies, and healthcare professionals.

Key Requirements

The standard outlines several key requirements that must be adhered to in the development of standards for single herbal medicines. These include:

• Terminology: Clear definitions and terminology related to herbal medicines are established to promote consistency and understanding across the industry.
• Standardisation Process: A structured approach for the standardisation of herbal medicines is detailed, ensuring that all relevant factors such as sourcing, processing, and quality control are considered.
• Documentation: Comprehensive documentation practices are recommended to support transparency and traceability in the production and distribution of herbal medicines.

Implementation Benefits

Implementing the guidelines set forth in ISO/TR 23975:2019 can yield significant benefits for organisations involved in the herbal medicine sector:

• Enhanced Quality Control: By adhering to standardisation processes, organisations can improve the quality and consistency of their herbal products, leading to increased consumer trust.
• Regulatory Compliance: Compliance with this standard aids organisations in meeting regulatory requirements, thereby reducing the risk of non-compliance penalties.
• Market Access: Establishing recognised standards can facilitate access to new markets, as consumers and regulators increasingly demand quality assurance in herbal products.

Compliance Value

Compliance with ISO/TR 23975:2019 is essential for organisations aiming to operate within the TCM sector. The standard provides a clear pathway for:

• Risk Management: By following the standard, organisations can identify and mitigate risks associated with the production and distribution of herbal medicines.
• Consumer Safety: Ensuring that products meet established standards protects consumers from potential harm due to substandard herbal medicines.
• Reputation Management: Adhering to recognised standards enhances an organisation's reputation, demonstrating a commitment to quality and safety.

In conclusion, ISO/TR 23975:2019 serves as a vital resource for the standardisation of single herbal medicines in Traditional Chinese Medicine. By implementing its guidelines, organisations can achieve significant compliance benefits, enhance product quality, and ultimately contribute to the safety and efficacy of herbal medicines.