(2002; 166 pages)
Pharmacopoeial specifications for new drug entities
Dr Ashwini Kumar, India
The availability of harmonized quality specifications of drugs through pharmacopoeias is central to all drug regulatory authorities for the access to safe, efficacious and quality medicines. There are some new drugs that are internationally traded and included in the WHO Essential Drugs Lists, but for which there are no readily available pharmacopoeial specifications.
A meeting was arranged during the 10th ICDRA, with participants from Brazil, China, Czech Republic, India, Russian Federation, Thailand and Zimbabwe, and telephone links to the European Pharmacopoeia and the United States Pharmacopeia, to discuss the development of pharmaceutical specifications for new drug entities. Efforts are needed to encourage international harmonization in the development of common specifications and international reference standards, with a special focus on new drug entities and drugs with major health impact, and the development of screening tests to help combat counterfeit drugs. It was agreed that the topic of pharmacopoeial requirements should be proposed for inclusion in the next ICDRA.
Role of drug regulatory authorities