Chinese Traditional Medicines Face Crucial Challenges in the New Regulatory Science: Approval and Reflection on Chinese Herbal Medicines

Traditional herbal formulae and conventional plant medicines have been recognized as “new” drugs approved in China and the complementary therapeutics appreciated in the West. With over 2,000 years evidence-based implementation in China, traditional plant medicines have showcased incredible modernized botanical drug development, but have not been accepted by international main stream medical markets due to the different understanding of traditional Chinese medicine (TCM). This article analyzed and reviewed the SFDA regulations, international general requirements, and crucial challenges when Chinese traditional drugs are registered. In addition, the constructive suggestions were outlined to advance the development of traditional plant medicines. Traditional plant medicines are facing the crucial challenges in these areas when registered and approved as modern drugs. New research ideas and strategies must be put forward and carried out if traditional plant medicines are extensively accepted by international main stream medical markets.