"On the deepening of the review and approval system reform to encourage" innovation of medical equipment of the drug is following the August 2015 "State Council on the reform of drug and medical device review and approval system", and a deepening reform of drug and medical device review and approval system programmatic document has milepost significance to the development of China's pharmaceutical industry innovation.
In recent years, the State Food and drug administration proposed to seriously implement the national food and drug supervision "the four most important instructions and to deepen the reform of drug and medical device review and approval system, implement the Party Central Committee and the State Council reform plan, make great efforts to reform medical drug review and approval system, seize the national implementation the favorable opportunity of innovation driven development strategy, adhere to the people-centered development ideas, and strive to create a policy environment to encourage innovation, promote the pharmaceutical industry into innovation driven development track; to encourage new innovation of medical equipment research and development and improve the quality of generic drugs efficacy to grasp the two promotion", to promote the protection of intellectual property rights; insist on the use of the thinking of the rule of law and the rule of law to promote reform, accelerate the improvement of food and drug supervision system. Have carried out the drug marketing authorization holder system pilot, generics quality consistency evaluation and efficacy of clinical trials, data checking and verification, adjust the classification of medical devices and other reform initiatives, to solve the registration and approval of drugs backlog serious problem, a number of innovative drugs and clinical need medical priority listing, provides more choices for the treatment of disease, improve the masses of the people to gain a sense of reform.
At present, there are many favorable conditions to encourage the innovation of medical equipment.
1. the innovation of domestic medicine is rising. In recent years, the number of new drugs and innovative medical instruments in China's pharmaceutical enterprises has increased year by year. Icotinib, apatinib, chidamide, Compaq SEPR 15 1 class of innovative medicines approved for production, 29 innovative medical devices approved. China's independent research and development of risperidone microspheres, Compaq SEPR ophthalmic injection and a number of domestic drugs in the US and European countries to apply for registration to enter the international market; reached the international advanced level of artificial heart valve system, breast x digital X-ray tomography equipment, implantable vagus nerve stimulation pulse generator and so on innovative medical devices after percutaneous intervention.
The reform of the 2. review and approval system has been progressing smoothly. In 2015, the reform of the review and approval system for drugs and medical devices began to improve the quality and standard of review, and improved the unhealthy atmosphere of scientific research and improved the transparency of review and approval. The problem of the backlog of drug review is resolved on time.
3. the evaluation of the consistency of the quality and efficacy of the generic drugs started smoothly.
The "opinion" for the current outstanding problems faced by the drug and medical device innovation, long-term system construction, put forward the reform of clinical trial management, to speed up the review and approval of drugs and medical devices, to promote innovation and development, strengthen the generic drugs and medical equipment life cycle management, enhance the ability of technical support to strengthen the organization and implementation of 6 part of a total of 36 reform measures.
The "opinion" suggested that the qualification of clinical trial institutions should be changed to the record management. Clinical trials are supported by clinical trial institutions and personnel.
The "opinion" proposes to speed up the examination and approval of the clinical medical equipment for medical equipment urgently needed for clinical medicine, allowing for approval to be listed on the listed conditions, and to carry out supplementary research according to the requirements after the listing.
The opinion supports the research and development of medical instruments for rare diseases, and the medical instruments that have been approved to be listed abroad may be listed on the condition of approval.
The opinions clearly promote the implementation of the license holder system. The license holders have all legal responsibilities for R & D, clinical trials, manufacturing, distribution and adverse reaction reports.
