3. Regulation of drugs containing nanoparticles

3.1 The origins of drug regulation

The idea of independent pre-market evaluation of medicines is a relatively recent one. It first appeared in various parts of the world around 1960 and, like many regulations, was unfortunately prompted by tragedies, such as that involving thalidomide in Europe. There is still no global drug regulation, but since 1990, awareness of a globalized market has led to the harmonization of regional regulations (Europe, USA and Japan) with the creation of the International Council for Harmonization (ICH). The ICH now brings together numerous regulatory authorities, as well as representatives of the pharmaceutical industry, the WHO (World Health Organization) and national observers from various countries. This organization brings together pharmacopoeias from...