Standardised and harmonised test methods are important for safety assessment of new chemical and pharmaceutical materials, to ensure comparability of results,  to facilitate knowledge transfer and to help to make regulation all over the world enforceable.

Standardization refers to the process of creating and implementing agreed-upon guidelines, specifications, and requirements for a product or process. As such, standardization facilitates review and acceptance of NAMs and is therefore an important part in its development and implementation. By providing a uniform format and structure for data and methods, standardization lays the groundwork for robust validation processes, ensuring that new methodologies can be reliably assessed and implemented across various contexts and regulatory framework.

Why standardization matters for NAMs?  

• Reliability and Reproducibility
  Standardization ensures that results are reliable and reproducible across different laboratories and settings, which is vital for establishing the credibility of new methods (Ref35, Ref41).
• Improved Data Quality
  It enhances data quality, accuracy, and consistency, providing a solid foundation for effective decision-making and regulatory acceptance (Ref35, Ref36).
• Comparability:
  Standardization facilitates comparability between various methods and traditional testing approaches, allowing for better integration into existing assessment frameworks (Ref41).
• Regulatory Acceptance
  Standardized methods have a higher success in validation and are more likely to gain regulatory acceptance, which is crucial for their application in safety assessments and decision-making processes (Ref41). Standardisation allows regulators to become familiar with elements of the method, rapidly assess adequacy of information, easily share information and easily link information to existing databases (Ref52).
• Regulatory Compliance
  It supports compliance with regulations by ensuring data consistency and accuracy, helping organizations meet industry standards and legal obligations (Ref35, Ref36).
• Enhanced Efficiency
  Standardization streamlines processes, reduces manual data handling efforts, and minimizes errors, ultimately saving time and costs associated with data management (Ref35, Ref36).

Challenges and Future Directions
Despite its significance, the standardization of NAMs faces several challenges:

• Lack of Definition: The definition and process of standardization for NAMs are not well-defined and can vary across different contexts (Ref42).
• Resource Investment: Standardization requires substantial investment in time and resources, including multi-laboratory validation studies (Ref43).
• Rapid Technological Development: The fast-paced development of new technologies and methods in the field of NAMs necessitates flexible and adaptable standardization approaches for NAMs (Ref44).

How The Netherlands Standardization Institute (NEN) helps

The NEN (or the Royal Netherlands Standardization Institute) is a private, non-profit organization that plays a crucial role in standardization within the Netherlands. It serves as the national standardization body, responsible for developing, managing, and promoting standards across various industries and sectors. The NEN assists in the development and management of both national (NEN) and international standards (ISO, IEC, EN)  and can be contacted for help with standardization. 

The NEN is working on global standardisation of MPS and OoC systems to enhancing reproducibility, comparability, and interoperability (Ref46). Given that MPS and OoC is still a new and innovative field, there will be a significant number of standards developed in the coming years.