Introduction
!Traditional Chinese medicine (TCM), one of the treasures of the Chinese nation, has made great contributions to the development of both Chinese and world civilization for thousands of years. As traditional medicine and the research technology of TCM develop more rapidly than ever before, much attention is being paid to it worldwide because of its abundant resources, unique curative effects, low toxic and side effects, and more is being invested in its research and development while posing more demanding requirements for the quality of TCM products. However, many problems exist during the conventional TCM herbs production process in China, including unclear germplasm resources, substandard planting and processing techniques, excessive pesticide residue and poor quality of TCM herbs, thus leading to inconsistent quality of Chinese-made TCM products and severely affecting the stability of the curative effects of TCM as well as the lead position of Chinese TCM products in the world drug market. These challenges can be tackled in part through a Good Agricultural Practices (GAP) approach, which aims to standardize the cultivation, collection, and processing of TCM herbs, improving their quality and bringing TCM in line with the international practice, being therefore a key to the modernization and internationalization of TCM.
GAP for TCM herbsGAP for TCM herbs, referred to as Chinese crude drugs (CCD) in Chinese official documents, is intended to control various factors affecting the production quality of medicinal plant materials, to standardize various crude drug production processes and even the whole process so as to ensure that TCM herbs are authentic, safe, effective, and consistent in quality [1]. Herein, TCM herbs cover CCD, herbal medicines, ethnodrugs, and introduced botanical drugs.
Formulation of GAP for TCM herbsAlong with the worldwide trend for returning to the nature, people are paying more attention to the medical and health care function of traditional medicines, especially TCM, and some countries have formulated relevant legislations concerning the quality control of herbal medicines. Many countries have taken a series of standardized measures concerning quality control of production of raw materials for natural medicines. For example, the Japanese Ministry of Health, Labor, and Welfare revised Medicinal Plants Planting and Quality Evaluation in 1992; the US government issued a draft FDA Guidance for Industry: Botanical Drug Products in 1996; the European Herb Growers Association (Europam) proposed Good Quality Control of Medicinal Plants and Animals in August 1998; later, the European Union (EU) drafted Guidelines for Good Agricul-
Abstract
!In this paper, we briefly review international Good Agricultural Practice (GAP) regulations related to traditional Chinese medicine herbs (TCM herbs) and the background of the drafting process and the implementation of GAP for TCM herbs in China. We also have summarized progress and achievements since the implementation of GAP for TCM herbs in 200...