Introducing a System for the Assessment of Quality, Safety, and Efficacy of Herbal Medicinal Products in the Netherlands
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on92-~61~/2001 Copyright 0 2001 Drug Information Association Inc.
INTRODUCING A SYSTEM FOR THE ASSESSMENT OF QUALITY, SAFETY, AND EFFICACY OF HERBAL MEDICINAL PRODUCTS IN THE NETHERLANDS WILLEMK. SCHOLTEN, MSc, PHARM, MPA Head of the Office of Medicinal Cannabis, Department of Pharmaceutical Affairs, Ministry of Health, Welfare and Sport, The Hague, The Netherlands
S. BARTA. HALKES,PHD Post-Doc Research Associate, Department of Medicinal Chemistry, Faculty of Pharmacy, Utrecht University, The Netherlands
Currently, a global change in the approach to herbal medicinal products can be observed and in many countries new regulations are developed for this class of products. Iniplementation of such legislation is necessary to guarantee the quality, sajety, and efficacy of herbal medicinal products. The Dutch policy is to facilitate this process and to effect a smooth transition. To achieve this, the Dutch government has laid down a Royal Decree on Herbal Food Products, which aims at increasing the safety of food supplements containing medicinal herbs. In addition, it financially supports the activities of the private Committee for the Assessment of Phytomedicines. This committee? explicit goal is to set up a self-regularing system f o r monitoring the qualiw, safey, and efJicacy of herbal medicinal products. For this purpose, it has developed operational methodology and explored some of the specific problems in this respect. This arrangement is made in anticipation of specific European guidelines for herbal medicinal products. Key Words: Herbal medicinal products; Regulation; Quality; Safety; Efficacy
INTRODUCTION IN LARGE PARTS of the industrialized world the use of herbal medicinal products declined during the second half of the 20th century, as compared to the era in which chemical medicines were not widespread yet. This article is based on a presentation prepared by the authors and given by Willern Scholten at the 36th DIA Annual Meeting, June 10-15, 2000, San Diego, California. Reprint address: Dr. S. Bart A. Halkes, Department of Medicinal Chemistry, Faculty of Pharmacy, Utrecht University, PO Box 80082, 3508 TB, Utrecht, The Netherlands.
Since this was also the period in which most pharmaceutical legislation and licensing procedures for medicinal products were developed, specific regulation for herbal medicinal products was not undertaken. However, recently a strong revival of interest in herbal medicinal products can be observed and, at this moment, in many countries regulations are in preparation. Thus, Australia has changed its regulation of complementary medicines recently (1). Likewise, in LatinAmerica several countries made regulations especially for herbal medicinal products in recent years: Mexico in 1998, Argentina in 1999. and Brazil in 2000 (2). Canada reen-
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Willem K. Scholten and S. Bart A. Halkes
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gineered its policy organization to be able to pay more attention to complementary medicines and founded an Office of Natural
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