The era of consistency evaluation is coming, and the potential of Medea medicine in Zhejiang Province is black horse

Recently, the State Food and Drug Administration released information that the quality and efficacy consistency evaluation of generic drugs, which has attracted the attention of the pharmaceutical industry, has achieved phased results - 17 product specifications have successfully passed the consistency evaluation of generic drugs, involving 12 varieties, and 7 pharmaceutical enterprises have completed the evaluation on time This is the first batch of conformity assessment projects successfully completed since the State Council issued the opinions on the quality and efficacy conformity assessment of generic drugs in February 2016 It can be seen that domestic pharmaceutical enterprises, especially those focusing on product quality, have begun to put into practice It is expected that the impact of the government's efforts to improve the quality of drug research and development will begin to show, and the subsequent social effects will gradually enlarge A large number of consistency evaluation projects are still in the stage of project research and application, and the completed project announcement will be published continuously In the face of such opportunities, powerful cro institutions will become the market darling In such a huge consistency evaluation market, cro institutions with advanced technology, equipment, information management system and other advantages like Zhejiang Metso Pharmaceutical Co., Ltd will be an important technical force to assist pharmaceutical enterprises to complete the consistency evaluation The core objective of the consistency evaluation of quality and efficacy of generic drugs is to comprehensively improve the quality of generic drugs and realize the clinical substitution of domestic generic drugs for the original drugs It is of great significance to carry out the consistency evaluation of quality and efficacy of generic drugs for improving the overall level of China's pharmaceutical industry, ensuring the safety and effectiveness of drugs, promoting the upgrading and structural adjustment of the pharmaceutical industry, enhancing the international competitiveness, generating linkage effects, promoting the structural reform of the entire pharmaceutical production field, and reducing the total expenditure of national medicine The quality improvement of national generic drugs will play a positive role In October 2017, the general office of the CPC Central Committee and the general office of the State Council jointly issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices, reiterating once again that it is necessary to accelerate the quality and efficacy consistency evaluation of generic drugs As of January 2, 2018, there were 309 consistency evaluation be records, 182 of which belong to the list of basic drugs, 73 varieties of 124 enterprises, 127 out of the list, 77 varieties of 84 enterprises; 6028 reference preparations were recorded, including 3141 varieties in the list of basic drugs and 695 enterprises Among the 12 varieties (17 specifications) that have passed the consistency evaluation, there are 4 varieties (4 specifications) in 289 specifications, and 8 varieties (13 specifications) in non 289 specifications With the further promotion and development of this project, the resource integration and technological transformation of Chinese pharmaceutical enterprises and even cro companies will continue to upgrade It is found that not all qualified technical service institutions and pharmaceutical enterprises can participate in the evaluation of equipment, personnel and technical ability requirements of the consistency evaluation project, especially for cro company, having excellent technical advantages and practical project experience is an important criterion for the completion of the project Zhejiang meice Pharmaceutical Technology Co., Ltd., with its technical strength and project operation experience of consistency evaluation of various dosage forms, will be one of the institutions for pharmaceutical enterprises to choose cooperation It is understood that Zhejiang meice Pharmaceutical Co., Ltd is a foreign cro enterprise that has only started to participate in the domestic drug R & D business in the past one or two years With its advantages in foreign R & D background and professional technology R & D team, Zhejiang meice Pharmaceutical Co., Ltd has established in-depth cooperation foundation with many domestic pharmaceutical enterprises It is reported that many consistency evaluation projects led by Zhejiang meice Pharmaceutical Co., Ltd are in different stages from R & D to application According to the person in charge of Zhejiang Metso pharmaceutical, the process of consistency evaluation, research and development is long and the workload is huge Among them, research and development involves dissolution and dissolution curve research, related substance content, and even miscellaneous mass spectrometry research, drug packaging material research, etc the time cycle is long, and the technical research and development ability, instrument and equipment configuration, and personnel number background of pharmaceutical enterprises and cro companies Very demanding The IPS of the United States, which has participated in the joint construction of USMC, has maintained long-term cooperation with Pfizer, AstraZeneca, Lilly and other world's top 20 well-known pharmaceutical enterprises While Zhejiang USMC, together with Zhejiang University of technology and Yangtze River Delta green pharmaceutical Collaborative Innovation Center, has built a technical service platform to help domestic enterprises carry out consistency evaluation From the United States to China, with a scientific, rigorous, realistic and refined professional attitude, Provide standard, high quality and high standard technical services According to the introduction, since the start of the business of Zhejiang meice Pharmaceutical Co., Ltd., there have been nearly 200 domestic cooperative enterprises, which are distributed in pharmaceutical enterprises, cro companies, national institutions of higher learning, research institutes and many other fields Up to now, the company has completed nearly 10 compliance evaluation cooperation projects, many of which have been reported and have rich experience in generic drug development Zhejiang meice Pharmaceutical Technology Co., Ltd (zhejiangps) is jointly founded by hankang holding group, IPS of the United States and Zhejiang University of Technology Asset Management Co., Ltd The company has a high-quality scientific research team, advanced R & D equipment and a third-party laboratory that meets the requirements of FDA standards The company mainly provides enterprises with objective, fair, independent and efficient drug analysis and testing, compliance testing services and market access testing services including API and preparation stability testing in accordance with national pharmacopoeia, American Chemical Association and customer specified standards, and can provide technical solutions in line with cGMP As a well-known cro company in China, it has rich experience in consistency evaluation IPS in the United States is the co construction partner of Zhejiang meice Pharmaceutical Co., Ltd., which has passed the FDA audit for many times and enjoys high industry authority in the United States The R & D team of the company has solid theoretical knowledge and rich practical experience, and is proficient in controlling drug R & D policies and regulations, mastering R & D process and consistency evaluation project leader who has been engaged in drug research in large pharmaceutical or CRO companies for more than ten years At present, advanced and first-class instruments and equipment are used in Zhejiang meice Pharmaceutical Co., Ltd the laboratory covers an area of more than 3000 square meters, with a total investment of more than 40 million yuan The perfect quality control system of Zhejiang meice Pharmaceutical Co., Ltd is a third-party laboratory established in full accordance with the requirements of FDA It is managed in accordance with the requirements of cGMP during the management The instruments and equipment are fully opened for audit tracking, which is in line with the requirements of FDA quality certification Many pharmaceutical enterprises, drug testing agencies, etc visited the quality management system and R & D technical achievements of the international standards supporting metformin for many times, and won the professional recognition of many customers and peers Some professionals said that consistency evaluation is a good policy for the overall improvement of the pharmaceutical industry With the release of a series of programmatic documents in the pharmaceutical industry, innovative drugs and consistency evaluation will be the main direction of the future development of medicine Although China's cro market started late, it is now facing the most favorable opportunity in history In 2006, the scale of China's cro market was only 3 billion yuan In 2013, the scale of China's cro market has grown to 22 billion yuan, with an average compound growth rate of 32.9%, maintaining a high growth rate Cro industry will benefit from the promotion of consistency evaluation and usher in great development opportunities According to the relevant person in charge of Zhejiang meice Pharmaceutical Co., Ltd., relying on its strong technical R & D strength, Zhejiang meice Pharmaceutical Co., Ltd will assist domestic pharmaceutical enterprises to carry out and complete the consistency evaluation work smoothly, and will work with many cro enterprises to promote the quality improvement of domestic pharmaceutical products and make practical actions As one of the leading cro organizations in China, Zhejiang Metso pharmaceutical has become an important participant in the consistency evaluation of Chinese pharmaceutical enterprises It is understood that Zhejiang meice Pharmaceutical Co., Ltd is an important force under hankang holding Since the layout of large-scale health industry, hankang Holdings has expanded in many subdivisional fields, such as medical service, pharmaceutical industry, health management, R & D technology service, health service, biotechnology, biological products, supply chain and pharmaceutical investment, realized the series interconnection among large-scale health industries, absorbed and established a whole set of ecological industry chain of large-scale health industry, with the promotion of business at all levels, It will release huge industrial energy As the core force of hankang holding to march into the big health industry, Zhejiang meice Pharmaceutical Co., Ltd has played a huge role in its own field and contributed a valuable puzzle to the big health industry of hankang holding With an open attitude, Zhejiang meice Pharmaceutical Co., Ltd is willing to carry out active and pioneering cooperation with national pharmaceutical enterprises to contribute to China's drug consistency evaluation.