Chinese medicine formula particle policy to relax the large-scale pharmaceutical enterprises to expand the military circle

Chinese medicine formula particle market has been monopolized for many years, for this reason, the relevant policies make the industry increasingly open. However, full openness may exacerbate market competition, while the State has also strengthened the norms and requirements for enterprise production. Industry insiders generally predict that due to the standard in a short period of time "difficult to produce", the real landing of the filing system is still some time.Profitable but eating alone
In July 2001, the former State Drug Administration issued the Interim Regulations on the Administration of Chinese Medicine Formula Particles, which included Chinese medicine formula particles in the category of Chinese medicine tablets and implemented the management of the approval number of drink tablets. Between 2002 and 2004, a total of six enterprises, including Jiangyin Tianjiang Pharmaceuticals, Guangdong One-Party Pharmaceuticals, Beijing Kangrentang Pharmaceuticals, China Resources 39 Pharmaceuticals, Sichuan New Green Pharmaceuticals, Peili (Nanning) Pharmaceuticals, were approved by the State Administration of Food and Drug Administration. Since then, there has been no increase in pilot enterprises. The market is also very profitable, with a growth rate of about 50% a year, and only six companies are eligible for the profits of the market over such a long period of time.Policies are becoming more and more open
In December 2015, the State Administration of Food and Drug Administration (hereinafter referred to as the General Administration of Food and Drug Administration) issued a draft for comments, showing that the pilot restrictions on formula particles will be liberalized - Chinese medicine production enterprises only need to go through the local provincial food and drug supervision department approval, and in the scope of the enterprise's drug production license production, and then in accordance with the requirements of the "Chinese medicine formula particles record management regulations", to the local provincial food and drug regulatory departments to submit information for the record.
February 26, 2016, the State Council issued the Outline of the Outline of the Chinese Medicine Development Strategy Plan 2016-2030, which explicitly incorporates Chinese medicine formula particles into the National Chinese Medicine Development Strategy Plan.
March 1, 2016, the "Chinese medicine formula particle management measures (draft for comments)" ended to the public consultation, the industry opening trend has gradually become clear.
although the industry standards are still very confusing, the draft clearly stipulates that the National Pharmacopoeia Commission will organize the formulation and revision of uniform drug standards for Chinese medicine formula particles. However, the industry generally predicted that because the standard in a short period of time "difficult to produce", the real landing of the filing system is still some time.Policy to relax the hearts of food-eaters more than
large pharmaceutical companies in the pilot period has been eyeing this cake, although the market has not been opened at that time, the policy is also unclear, but the enterprise is still early to the bureau, hoping to expand the military circle, but in the "pilot did not let go" threshold, has always been named, can not formally enter.
shenwei pharmaceutical industry in scientific research has been prepared to complete the study of 400 varieties. Shenwei Pharmaceuticals has been carrying out research on Chinese medicine formula particles, aiming at high-end research methods and standards at home and abroad, established a production process, quality control system and quality standards covering more than 700 commonly used Chinese medicine formula particles, and for the first time put forward the concept of "Chinese medicine formula particle standard soup" and its modulation method.
a senior executive of Guangdong Xiang Xue Pharmaceuticals said it was not convenient to disclose the situation because of the regulations of listed companies. But according to a pilot enterprise insider in the same province, Xiang Xue Pharmaceuticals also has plans to expand in this area.
In January 2016, Kangmei Pharmaceuticals announced that it plans to invest 650 million yuan to build a Chinese medicine formula particle project in Puning City, Guangdong Province, and is expected to develop and produce about 450 varieties of Chinese medicine formula particles, such as licorice, dates, and white herring, with an annual output of about 2.4 billion packages.
Zoli Pharmaceuticals layout of Chinese medicine formula particles, the future will enjoy the market expansion dividend in 2015 the company with 130 million to obtain 51% of the shares of Herbal Chinese medicine, cut into the field of Chinese medicine tablets. In order to seize the opportunity of restrictive liberalization of Chinese medicine formula particles, the company intends to invest 110 million to speed up the construction of chinese medicine formula particle production line project, plans to complete more than 300 particle varieties of research and development and production this year, and strive to obtain formula particle production qualifications by the end of the year, start production next year.
Shanghai Pharmaceuticals, a wholly owned subsidiary of Shanghai Pharmaceutical Co., Ltd. and Japan's TSUMURA and CO. (Tsinmura, Co., Ltd.) jointly invested in the establishment of a company with a registered capital of 600 million yuan to carry out the production and sale of chinese medicine, Chinese medicine formula particles, Chinese medicine extracts and other products. Industry insiders say the move is intended to quickly cut into the Chinese medicine formula particle market.
chinese medicine formula particles pilot production restrictions will be expected in the next year to fully liberalize Chinese medicine enterprises, with the gradual increase in the number of enterprises, it can be expected that its competition will become increasingly fierce. But for enterprises that do not have the qualifications for the production of Chinese medicine granules, the production of formula particles needs the corresponding standards from the state to create favorable conditions for the industry to open up production. (Enlightening Guhan Group)