Evolution of activities in international biological standardization since the early days of the Health Organisation of the League of Nations

摘要

The main activities in international biological standardization during the 18 years that followed the first international biological standardization meeting in London in 1921 were concerned with expressing the potencies of test preparations in comparison with reference materials. After the Second World War, however, it became clear that the testing of biological substances against international reference materials was only one among several measures for obtaining safe and potent products. The activities in international biological standardization were therefore widened so that, by the strict observance of specific manufacturing and control requirements, it was possible to gain further in safety and efficacy. At the end of 1987, 42 international requirements for biological substances were available and were being used as national requirements, sometimes after minor modification, by the majority of WHO's Member States. This is of utmost importance for the worldwide use of safe and potent biological products, including vaccines.