Chinese medicine formulations particles market monopoly for many years, in July 2001, the former State Food and Drug Administration issued the “Chinese medicine formulations particles Management Interim Provisions”, will Chinese medicine granules included in the scope of Chinese Herbal Medicine, Herbal implement approval number management. 2002–2004 years, through the National Food Administration drug review the record and get the pilot, the company approved a total of six companies, including Jiang Yin Tianjiang Pharmaceutical, Guangdong side Pharmaceutical, Beijing Kangren Tang Pharmaceutical, China Resources Sanjiu Pharmaceutical, Sichuan new green medicine, Empowerment (Nanning) Pharmaceutical. Thereafter, the pilot enterprises not increased. The market is also very generous profit, about 50% annual growth rate, in such a long time actually only six companies are entitled to market profits.
December 2015, the State Food and Drug Control Administration (hereinafter referred to as the Food and Drug Administration) issued draft, limiting the pilot show will be open formulation particles – traditional Chinese medicine production enterprises only after the seat of the provincial food and drug administration departments approval, and to increase Chinese medicine granules in pharmaceutical production enterprise license production range, then in accordance with “Chinese medicine formulations particles filing governance Rules” requirement to submit filings to the provincial food and Drug Administration department, can be produced.
Full liberalization may exacerbate market competition. Meanwhile, the state also strengthened the production specifications and requirements. While the industry standard is still confusion, the draft clearly defined by the State Pharmacopoeia Committee organized a unified Chinese medicine formulations particles of the drug formulation and revision of standards. However, industry sources speculated general, since the standard in a short time “giving birth”, the record made real floor still to fear.