OBJECTIVE:To provide reference for the sustainable development of pharmaceutical enterprises in Guizhou prov-ince. METHODS:A questionnaire was conducted for 55 pharmaceutical enterprises in Guizhou province,the basic situation of en-terprises,familiarity of related directors to Good Manufacture Practice of Drugs(GMP)and relevant policy,the current situation of implementing the new version GMP were investigated and statistically analyzed,problems were found,and corresponding coun-termeasures were put forward. RESULTS & CONCLUSIONS:Totally 55 questionnaires were sent out,49 valid ones were received with effectively recovery of 85.1%. The results showed 43 enterprises(87.8%)had passed the GMP authentication;only 13 enter-prises(26.5%)directors were very familiar with the new version GMP. In terms of personnel management,the head of production management and quality management and the authorized person of quality and personnel had not yet met related requirements of the new version GMP fully;in terms of equipment and production management,production area transformation(clean areas,lounges, warehouses,water use) and air purification system design in most enterprises met related requirements of the new version GMP, 23 enterprises (46.9%) still can not conduct fully inspection to products and materials;in terms of document management,there were still some enterprises not meeting the new version GMP standards fully,enterprises'documents(health area layout,air purifi-cation layout,management procedures,operating procedures,etc.) of production site were imperfect. According to the investiga-tion,the main existing problems included lack of funds in implementing the new version GMP reform,not enough understanding or familiarity with the new version GMP,relevant personnel management not reaching the designated position,equipment and pro-duction management needing to be strengthened,document management systemic being poor,risk management being not sound, etc. It is suggested that government should give all forms of capital policy and strengthen the training of the new version GMP;en-terprises should attach great importance to the relevant personnel management,strengthen the equipment and production manage-ment,set up perfect document management system and a sound system of risk management.

OBJECTIVE:To provide reference for the sustainable development of pharmaceutical industry in Guizhou province.METHODS:By literature review,personal interview and questionnaire survey,the current situation about the development of pharmaceutical industry in Guizhou province were investigated and analyzed,and the corresponding countermeasures and suggestions were put forward.RESULTS:The literatures were obtained from network literature by Baidu search engine,published data by government portal website of administrative department,documents by CNKI and VIE Five personal interviews involved the relevant management personnel in Policies and Regulations Department,Medicine and Cosmetics Production Supervision Department,Medical Device Supervision Department of Guizhou Province Food and Drug Administration.A total of 70 questionnaires (drug production enterprises as object) were sent out,and 57 valid questionnaires were collected with the effective recovery rate of 81.4％.In the present,there were a total of 175 pharmaceutical production enterprises (56.5％ in Guiyang city) and 106 medical device manufacturers in Guizhou province.Of 57 pharmaceutical manufacturing enterprises investigated,87.8％ of them were certified by the 2010 edition of Good Manufacturing Practice (GMP).The number of varieties of Chinese herbal medicines in Guizhou province ranked second in the whole country;total area of Chinese herbal medicine planting,wild protection and tending ranked third in the whole country in 2015;the industrial output value of Chinese patent medicine accounted for 85.1％ of the total output value of the pharmaceutical industry;but no approved new medicines were class 1 and 2 new medicines;R&D personnel with high education levels took small proportion significantly.The output capacity of chemical medicine industry was far lower than the average national level;the chemical industry output value accounted for only about 10％ of the total output value of the pharmaceutical industry in the province;the rate of success approval was almost zero for new drugs declared by drug manufacturers in recent years.Biological products industry was an emerging industry,currently there were only 3 biological products production enterprises.Of 341 products in medical device industry,there were 146 class Ⅰ products,190 class Ⅱ products and 5 classⅢproducts,manifesting as narrow coverage,few production type,relatively backward level.Seven percent of pharmaceutical production enterprise involved in the derivatives industry,and the development of TCM health care industry attracted more and more attention.CONCLUSIONS:The Chinese and national medicine industry has been the dominant force,the development of chemical medicine,biological products and medical device indusmy has lagged behind,and medicine derivatives industry needs to promote the integration of TCM and health-and-fitness.Thewhole industry strategic consciousness is comparatively backward,high-end R&D personnel is lack,and independent innovation ability is weak.It is suggested to done the top design,guide enterprises mergers and restructuring;develop characteristic medicine,support small molecule chemical medicines and biological products enterprises deeply;deepen the understanding of industrial policy,and increase investment in independent innovation;develop new medicine derivatives,and expand the pharmaceutical e-commerce sales channel;broaden the industry chain depth,breadth and width,and excavate medical big data.

OBJECTIVE:To provide reference for benign sustainable development of traditional Chinese and ethnic medicine enterprises in Guizhou. METHODS:Taking 129 traditional Chinese and ethnic medicine enterprises of 9 city and prefecture in Gui-zhou as survey object,questionnaires survey was conducted in 55 enterprises by stratified sampling according to location. The data statistical analysis was carried out in respects of related policies familiarity,product positioning,independent innovation from 2009 to 2013. Relevant development countermeasures were put forward. RESULTS & CONCLUSIONS:45.1% of enterprises ex-pressed to know and be familiar with relevant policies,51.0% expressed to alert but only understand,and 3.9% said largely un-known. At the past five years,the annual output value and sales revenue of enterprises had risen year by year. Almost 80% produc-tion and technical personnel of enterprises had the junior title or no title;marketing department staff mainly had college and second-ary school degree,accounting for 47.5% and 25.3% respectively;research personnel mainly had bachelor and college degree,ac-counting for 57.0% and 33.7% respectively. At the past five years,independent innovation input took up 2.4% of sales revenue av-eragely. There are problems,such as small and medium enterprises occupying dominate position;enterprises lacking of sufficient understanding on related policies;strategies being adjusted slowly;independent innovation input intensity needing to increase. Countermeasures and suggestions are put forward,such as strengthening the relevant policy advocacy,guiding corporate mergers and acquisitions,closely paying attention to industry development,changing innovation ideas,and attaching importance to research of exclusive production of essential medicine.