WHO Expert Committee on Specifications for Pharmaceutical preparations : 34th report

This report sets out a series of 12 international guidelines and other recommendations intended to assist national drug regulatory authorities and manufacturers in the quality control of pharmaceutical products.

Concerns addressed include the need to ensure that pharmaceutical products moving in international commerce are of acceptable quality, that generic drugs are therapeutically equivalent to innovator products, and that drugs retain their quality, safety and efficacy throughout their designated shelf life, particularly under extreme climatic conditions often found in developing countries.

Although the report has universal relevance, its guidelines is of particular in countries attempting to establish or strengthen a regulatory framework for pharmaceutical products.

All recommendations share the ultimate goal of helping regulatory authorities to safeguard the health of patients by protecting them from substandard or counterfeit products.