The Harmonization of Pharmacopoeias

Article excerpt

Byline: Magdalena C. Cantoria, Ph.D.

SINCE 1964, the market for medicinal and pharmaceutical products has become global. Now there is a need for international harmonization of standards of quality for these products. These are done in various ways. Books of standards for drugs and devices, known as pharmacopoeias and formularies, are referred to collectively as drug compendia. Modern pharmacopoeias, on the other hand, are very specialized reference works issued or authorized by governments or by international agencies. They present official standards for identity, purity, and quality of drugs and are used mostly by pharmaceutical scientists and manufacturers. Formularies are usually lists of drugs approved for use by a particular hospital, health plan, or government. Many hospitals and health plans have committees to decide which drugs should be included in their respective formularies.

In 1989, the Pharmacopoeia Discussion Group (PDG) was formed with representatives from the European Directorate for the Quality of Medicines in the Council of Europe (EDQM), the United States Pharmacopoeia Convention, Inc. (USPC), and the Japanese Pharmacopoeia in the Ministry of Health and Welfare -- now the Ministry of Health, Labour, and Welfare (MHLW). Since 1990, the PDG has coordinated the pharmacopeial harmonization work among the three major pharmacopoeias of the world, namely, the European Pharmacopoeia, the United States Pharmacopoeia, and the Japanese Pharmacopoeia. In May, 2001, the PDG welcomed the World Health Organization (WHO) as an observer.

Why do we need to harmonize pharmacopoeias from various parts of the globe? Pharmacopoeial harmonization benefits manufacturers of medicinal and pharmaceutical products intended for human use, regulatory agencies, and ultimately, health practitioners, and patients. Significant benefits are the simplification and rationalization of quality control methods and registration with regulatory authorities. Harmonization of monographs sets identical requirements for as many attributes of a product as possible.

Pharmacopoeias in the World Involved in Harmonization

The European Pharmacopoeia. The European Pharmacopoeia was inaugurated in 1964 under the auspices of the Council of Europe in accordance with the terms of the Convention on the Elaboration of a European Pharmacopoeia. This was amended by the Protocol to the Convention and signed by the governments of 31 European countries and the European Union. At present, observers from 16 European countries and non-European countries and the WHO are admitted.

The Convention appointed the European Pharmacopoeial Commission (EPC) to prepare the fifth edition of the European Pharmacopoeia. Published on 15 June 2004, it is now widely used internationally.

The pharmacopoeia has tried to establish standards for the quality of medicines in the countries that are signatories to the convention. These standards have been legally enforced in these countries. Manufacturing and quality control standards for medicinal products in the European market had to be harmonized to promote public health, to facilitate the free movement of medicines, and to ensure the quality of medicinal products manufactured in Europe. The standards are the basis for the safe use of medicines by patients, consumers, and health care professionals. The monographs also meet the needs of regulatory authorities and manufacturers.

The United States Pharmacopoeia Convention. The United States Pharmacopoeia Convention (USPC) aims "to promote public health and benefit practitioners and patients by disseminating authoritative standards and information developed by its volunteers for medicines, other health care technologies, and related practices used to maintain and improve health and promote optimal health care delivery. …