International Reference Standards

The lack of uniformity in measuring, testing and evaluating biological materials makes it difficult for regulatory agencies, physicians, scientists and manufacturers to share medical information and products. The World Health Organization (WHO) created the Expert Committee on Biological Standardization (ECBS) to guide the effort for international standards.

Purpose

• Biological materials are not easy to standardize.

  Biological materials are more difficult to standardize than other products. For example, in finding an immune factor in a blood product, aspects such as laboratory instruments used, testing methods, product temperature, preservation methods and chemical stabilizers can influence the test results. The ECBS creates groups of international experts who meet regularly to evaluate recommendations and provide guidance in developing standards.

Developing Countries

• WHO is concerned with standards in developing nations.

  International standardization of biological material is important for developing countries' health care efforts. One of the missions of ECBS is to recommend uniform standards for these nations' laboratories and hospitals, so that exchange of information and products can take place safely.

Vaccines

• Correctly measuring immunity factors can depend on testing methods.

  The threat of pandemic infectious diseases is one of many challenges facing WHO. The ECBS's group for vaccines analyzes immunization levels and standards, comparing results from different laboratories around the world. While the expert panels make recommendations on quality and safety, it is up to national authorities to conform to international standards.