Pharmaceutical Inductive review, speed up and innovative drugs accelerate
Release time: 2011-07-15 & nbsp & nbsp & nbsp Source:
Business News Agency, July 15th. Reporter learned from the 2011 National Food and Drug Supervision and Management Symposium held in Nanjing in Nanjing，In (Application for Clinical Research on New Drugs) review and approval greatly accelerate，Qianqiang problems have been solved basically，Drug research and development and innovation research activities are active and orderly。
Li Guoqing, director of the National Food and Drug Administration (SFDA) Pharmaceutical Review Center, introduced at the meeting，The current inspection of IND is greatly accelerated，About 20 days before the time stipulated by the regulations。Questions of the queue also solved basically，IND reported in April this year，It has been in the review plan now，The review will be launched in accordance with the program。
Li Guoqing also disclosed the relevant review data in the first half of 2011: 3359 new applications (according My stake betting appto stake betting appthe acceptance number)，increased by 10%year -on -year; in the new application project，New medicine (including innovative drugs) accounts for about 38%，Imitation drugs account for about 52%，13290_13325。Look at the medicines that have been approved for marketing，There are Ekntini tablets、Domestic Lamif fixed film、Detonoscope (imported)、Intestinal Virus type 71 (referred to as EV71) Inactivated vaccine (clinical), etc.，Distributed in more treatment areas，Provides more new drugs and treatment methods for clinical medical treatment，improved the public's acquisition of medicines。
"The application volume is stable and there is a lifting，The application structure is still reasonable。"Li Guoqing expressed satisfaction with the pharmaceutical research and development of the application and review data in the first half of the year，I believe that this situation is more in line with the laws and trends of international drug research and development，Reflect that the current drug research and development and innovation research activities in my country are active and orderly。
In addition，Li Guoqing also revealed the relevant review conclusions: the first half of this year，The review center sent to SFDA for approval is 1879。The approval rate for the application of new drugs is 65.7%; the approval rate of imitation application is 73.6%; the approval rate of supplementary application is 66.6%; the approval rate of import application is 69.9%;。
Encouraging drug research and development innovation is the policy guidance that has paid great attention to the approval of drug review in recent years。and the great speed speed up of the index is the outstanding performance of encouraging innovation。Li Guoqing said，The speed stake online sports bettingMy stake betting appof review is greatly improved，On the one hand, this year's Drug Review Center completed the internal institutional reform，Innovation medicine、Evaluation of the Department of Drug Sub -Department; at the same time，List IND review as the preferred project task，The most invested review resources，The purpose is to further reflect the support and encouragement of innovation in the review work，improve efficiency under the premise of ensuring the quality of review。On the other hand, it has changed the concept of IND review。
Drug innovation is a high risk、Long cycle、High -invested activity，Generally, an innovative drug is successfully listed from the project to the end，It takes 10 or even 12 years to time。and clinical trials are the longest part of the cycle。Former，The industry has always been very criticized for the clinical trials of the review and approval of my country's review and approval。Some people in the industry said，American IND approval time is 30 days，India 40 days，The time stipulated in China's regulations is 60-90 days，In actual operation，"It's normal for more than a year。"This greatly extended the cycle of new drugs。
Li Guoqing said，Encourage innovation，Accelerate the review and approval of innovative drugs，The most prominent is the clinical trial link。The application that meets the requirements should be approved as soon as possible，Carry out clinical exploration as soon as possible。Under the guidance of this concept，January this year，Drug Review Center is in the reform of internal institutions，The main responsibilities of the center and the internal agencies have been adjusted largely，Increasing the department、Communication of judges of the same professional My stake betting appstake betting appprofession，and the review of generic drugs and innovative drug reviews for review，From this，The efficiency of review is significantly improved。
"Limited resources，When the review task is heavy，This is the preferred solution。For generic drugs，Because there is supply in the market，Some even dozens of hundreds of companies produce，Market supply is sufficient or even excessively requested，The needs of the people can meet the demand for medication，Under the condition of limited review resources，Properly slowing down its review speed is a scientific and reasonable choice。"Li Guoqing analysis said。
The reporter also found in the interview，SFDA Review Center has also changed greatly in principle in the independence。Former，In addition to examining clinical trials in the indecent review，It is also required to answer what the preparation is ready to make、How to improve quality standards after listing、How to control product quality, etc.，and more security、Effective Questions。Now，Indic review emphasizes whether the design of its research plan is scientific and reasonable，Is there a good risk control plan，Is there any prediction of possible risks，Is there any response measures and solutions, etc.。This，Li Guoqing explained，New drug research is a long and complex process，Different problems solved different stages，review should also be required and reviewed by the problems faced by different research stages。The clinical trial of the new drug is a safety of drugs、Effective、Research and exploration process for usage and dosage，The admission review of this link does not require the safety of the application of drugs、Effective evaluation，As long as there is a stake betting appstake sports betting appbasic judgment through the early animal experiments。"Because this project can finally become a medicine or unknown，Don't expect to find out all possible problems in the future in this link。”
Talking about the next plan，Li Guoqing said，The clinical trial data specifications of "major new drug creation" varieties will be used as the entry point，Procedure of strengthening clinical trials，Explore the scientific model of my country's clinical trial management，Explore the direction of the standardization of data，For the supervision of strengthening the drug research process, get out of the new road。(Wang Dan)
Li Guoqing, director of the National Food and Drug Administration (SFDA) Pharmaceutical Review Center, introduced at the meeting，The current inspection of IND is greatly accelerated，About 20 days before the time stipulated by the regulations。Questions of the queue also solved basically，IND reported in April this year，It has been in the review plan now，The review will be launched in accordance with the program。
Li Guoqing also disclosed the relevant review data in the first half of 2011: 3359 new applications (according My stake betting appto stake betting appthe acceptance number)，increased by 10%year -on -year; in the new application project，New medicine (including innovative drugs) accounts for about 38%，Imitation drugs account for about 52%，13290_13325。Look at the medicines that have been approved for marketing，There are Ekntini tablets、Domestic Lamif fixed film、Detonoscope (imported)、Intestinal Virus type 71 (referred to as EV71) Inactivated vaccine (clinical), etc.，Distributed in more treatment areas，Provides more new drugs and treatment methods for clinical medical treatment，improved the public's acquisition of medicines。
"The application volume is stable and there is a lifting，The application structure is still reasonable。"Li Guoqing expressed satisfaction with the pharmaceutical research and development of the application and review data in the first half of the year，I believe that this situation is more in line with the laws and trends of international drug research and development，Reflect that the current drug research and development and innovation research activities in my country are active and orderly。
In addition，Li Guoqing also revealed the relevant review conclusions: the first half of this year，The review center sent to SFDA for approval is 1879。The approval rate for the application of new drugs is 65.7%; the approval rate of imitation application is 73.6%; the approval rate of supplementary application is 66.6%; the approval rate of import application is 69.9%;。
Encouraging drug research and development innovation is the policy guidance that has paid great attention to the approval of drug review in recent years。and the great speed speed up of the index is the outstanding performance of encouraging innovation。Li Guoqing said，The speed stake online sports bettingMy stake betting appof review is greatly improved，On the one hand, this year's Drug Review Center completed the internal institutional reform，Innovation medicine、Evaluation of the Department of Drug Sub -Department; at the same time，List IND review as the preferred project task，The most invested review resources，The purpose is to further reflect the support and encouragement of innovation in the review work，improve efficiency under the premise of ensuring the quality of review。On the other hand, it has changed the concept of IND review。
Drug innovation is a high risk、Long cycle、High -invested activity，Generally, an innovative drug is successfully listed from the project to the end，It takes 10 or even 12 years to time。and clinical trials are the longest part of the cycle。Former，The industry has always been very criticized for the clinical trials of the review and approval of my country's review and approval。Some people in the industry said，American IND approval time is 30 days，India 40 days，The time stipulated in China's regulations is 60-90 days，In actual operation，"It's normal for more than a year。"This greatly extended the cycle of new drugs。
Li Guoqing said，Encourage innovation，Accelerate the review and approval of innovative drugs，The most prominent is the clinical trial link。The application that meets the requirements should be approved as soon as possible，Carry out clinical exploration as soon as possible。Under the guidance of this concept，January this year，Drug Review Center is in the reform of internal institutions，The main responsibilities of the center and the internal agencies have been adjusted largely，Increasing the department、Communication of judges of the same professional My stake betting appstake betting appprofession，and the review of generic drugs and innovative drug reviews for review，From this，The efficiency of review is significantly improved。
"Limited resources，When the review task is heavy，This is the preferred solution。For generic drugs，Because there is supply in the market，Some even dozens of hundreds of companies produce，Market supply is sufficient or even excessively requested，The needs of the people can meet the demand for medication，Under the condition of limited review resources，Properly slowing down its review speed is a scientific and reasonable choice。"Li Guoqing analysis said。
The reporter also found in the interview，SFDA Review Center has also changed greatly in principle in the independence。Former，In addition to examining clinical trials in the indecent review，It is also required to answer what the preparation is ready to make、How to improve quality standards after listing、How to control product quality, etc.，and more security、Effective Questions。Now，Indic review emphasizes whether the design of its research plan is scientific and reasonable，Is there a good risk control plan，Is there any prediction of possible risks，Is there any response measures and solutions, etc.。This，Li Guoqing explained，New drug research is a long and complex process，Different problems solved different stages，review should also be required and reviewed by the problems faced by different research stages。The clinical trial of the new drug is a safety of drugs、Effective、Research and exploration process for usage and dosage，The admission review of this link does not require the safety of the application of drugs、Effective evaluation，As long as there is a stake betting appstake sports betting appbasic judgment through the early animal experiments。"Because this project can finally become a medicine or unknown，Don't expect to find out all possible problems in the future in this link。”
Talking about the next plan，Li Guoqing said，The clinical trial data specifications of "major new drug creation" varieties will be used as the entry point，Procedure of strengthening clinical trials，Explore the scientific model of my country's clinical trial management，Explore the direction of the standardization of data，For the supervision of strengthening the drug research process, get out of the new road。(Wang Dan)
