天然植物制剂在全球范围内是一个潜在的巨大市场。目前,在国际上,尤其是一些发达国家对于天然植物制剂的认识也在逐步深入,并已开始建立相应的管理、审评标准。我国有关中药开发的政策法规正在逐渐完善和规范,已初步形成了一个严格、科学的管理体系,并在逐步与国际接轨。今天我国的中药产业正面临着前所未有的机遇与挑战。要想抓住机遇迎接挑战,就有必要对新药开发的法规、程序和其内在规律有一全面、深入的理解,为此本刊特开设“开发指南”专栏,以期为推动中药新药事业尽一绵薄之力。 新药的开发涉及市场、科研、临床等诸多领域,受内在的规律和外部的法律、法规的制约。前期工作包括市场考察、项目定位、处方筛选及药材来源、制剂工艺、质量标准的确定及临床前的实验研究等各个阶段均应严格按照有关具体要求进行。新药转正后,将面临转让、仿制、移植等问题,且涉及到知识产权中专利保护、新药保护和中药保护等相关法规。并且药品作为一种特殊商品,国家尚有一些其它法规对其规范。 本刊将有计划地邀请各方面专家和部分成功企业做专题专论。并对于读者提出的有代表性的问题,请专家做相应解答。我们衷心希望中医药界广大科研工作者、企业人士等各相关领域积极参与,就中药开发中的有关问题进行广泛? Natural plant preparations are a potentially huge market worldwide. At present, in the international arena, especially in some developed countries, the understanding of natural plant preparations is gradually deepened, and corresponding management and review standards have been established. China’s policies and regulations on the development of traditional Chinese medicine are gradually improving and standardizing. A strict and scientific management system has been initially formed, and is gradually in line with international standards. Today’s Chinese medicine industry is facing unprecedented opportunities and challenges. To seize the opportunity to meet the challenges, it is necessary to have a comprehensive and in-depth understanding of the laws, procedures, and inherent laws of the development of new drugs. For this purpose, the magazine has set up a “Development Guideline” column in order to make every effort to promote the new drug industry of traditional Chinese medicine. Power. The development of new drugs involves the market, scientific research, clinical and many other fields, subject to internal laws and external laws and regulations. The preliminary work includes market inspections, project positioning, prescription screening, sources of medicinal materials, preparation processes, determination of quality standards, and preclinical experimental studies. All phases should be strictly followed in accordance with relevant specific requirements. After the new drug is established, it will face issues such as transfer, imitation, and transplantation. It will also involve relevant laws and regulations concerning patent protection, new drug protection and Chinese medicine protection in intellectual property. And medicine as a special commodity, the country still has some other regulations on its specification. The journal will systematically invite experts from all sectors and some successful companies to do thematic monographs. And for the representative questions raised by readers, ask experts to answer accordingly. We sincerely hope that the majority of scientific research workers and business people in the Chinese medicine community will actively participate in various related fields and carry out extensive issues related to the development of Chinese medicine.