Harmonization of OECD Guidelines for the Testing of Chemicals

The international harmonization of toxicity tests by the OECD in 1982 [4] was the first, and - so far - has been the most effective step in reducing the duplication of testing in animals for regulatory purposes. This is because a toxicity test conducted according to the OECD guidelines will be accepted by regulatory agencies in all OECD Member States. The 30 Member States of the OECD are the world's major industrial nations. A similar approach has thereafter been used for the safety and efficacy testing of drugs by the International Conference on Harmonisation (ICH) [5], which represents the three major economic regions, namely Europe, Japan, and the USA. Since 1990, the ICH has accepted harmonized guidelines for efficacy and safety testing of drugs and medicines, including animal tests. Again, the harmonization of test guidelines has led to significant reductions of testing in animals, as regulatory agencies worldwide now accept the results of a test conducted according to ICH guidelines.

The most important areas which require safety testing in animals, and in which the test guidelines have been harmonized at the international level, include:

• Industrial chemicals, pesticides, cosmetics, food additives, etc. (OECD-Guidelines for the Testing of Chemicals).

• Drugs and medical devices (International Conferences on Harmonization; ICH).

• Safety and efficacy of hormones and biologicals (Pharmacopoeias; European and US Pharmacopoeia).

• Vaccines and other immunologicals (WHO recommendations, European and US Pharmacopoeia).

This categorization shows that, in addition to drugs, industrial chemicals and pesticides, international test guidelines have also been harmonized for hormones and biologicals by the pharmacopoeias, and for vaccines by the World Health Organization (WHO). To date, the harmonization of international test guidelines for toxicity and safety testing has been the most successful approach to reducing animal testing for regulatory purposes.

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