Medical network - March 20, 2016, the state food and drug administration and continue to uphold the quality, the principle of fairness, efficiency, adhere to in accordance with the law, scientific and standardized evaluation according to regulation and approved for 206 pieces of pharmaceutical production (listed) registration (traditional Chinese medicine (TCM) 2 pieces, 188 chemicals, biological products (16), 3666 approved drugs for clinical trial registration (traditional Chinese medicine (TCM) 84, 3311 chemicals, biological products, 271).
In 2016, the state food and drug supervision and administration bureau according to the drug approval Suggestions, for the first time approved a golden flower clear sense of particles, malic acid, the effect of capsule, fumaric acid, baida quinoline, polyethylene glycol (peg) interferon alpha 2 b injection, bead single injection, bei that lu peptide pneumococcal conjugate vaccine injection, 13 price important therapeutic areas such as new drugs, to get the latest treatments for patients. At the same time the treatment approved piece, fumaric acid tenofovir two pyrazole cefuroxime ester pieces and domestic first generic drugs, drug accessibility for patients and provides the important guarantee to pay for sex.
The 2016 annual drug approval report for the year's drug registration application, review and approval of the overall situation, respectively to the chemical medicine, traditional Chinese medicine and biological products dealt review, review of data and time limit are analyzed.
The drug approval report 2016
In 2016, the state food and drug supervision and administration bureau (hereinafter referred to as the bureau), under the strong leadership of drug approval center (hereinafter referred to as the center of human medicinal) closely around the "state council on reform of the opinions of the drug review of medical equipment examination and approval system" (guo fa [2015] 44) requirements, continuously promote the reform of the review system, adhere to in accordance with the law, scientific and standardized evaluation according to regulation and to protect and promote public health.
Human medicinal center by strengthening review of project management, detailed review sequence, strengthening the management of time limit and set up a special team, increase the review staff, authorization issued by classification, technical requirements, specifications, and revising the review points play ShengJu credentials the team strength, improve efficiency and quality review. Administration of the annual review and presented for examination and approval of registration, a total of 12068 pieces (to accept order plan, similarly hereinafter), 3779 for receiving a new registration. Medicine and vaccine clinical trial application, Chinese medicine national medicine for all kinds of registration review have been implemented according to the time limit, completed the country is sent [2015] 44 files and administration of certain milestones.
A completion, drug registration application review
(a) review overall completion
1. Annual review of completion
In 2016, the administration of human medicinal center to complete the review and presented for examination and approval of registration, a total of 12068, and 943 pieces of application for registration to complete the review material defect for applicant recover supplement for personal data. The annual review of the registration number is increased by 26% in 2015, waiting for the review of application for registration has been by September 2015 at the peak of nearly 22000 fell to nearly 8200 (excluding filings to complete the review for defect waiting for an application for registration of the applicant information reply), basically eliminate the backlog of registration. All of 2016 to complete the review and presented administration examination and approval and waiting for an application for registration of the review situation compared to the first three years as shown in the figure 1.
Figure 1 in 2016 to complete the review and presented administration examination and approval and waiting for an application for registration of the review is compared with the first three years
The review to complete the application for registration of 2016, the drug registration for 10060, accounts for about 83% of the total finished quantity. All kinds of drug registration to complete the review to send 2016 innings number compared with the first three years as shown in the figure 2.
Figure 2 for 2016 kinds of drugs registration to complete the review board number compared with the first three years
2. All kinds of registration review completion
In 2016, human medicinal center to complete the new drug clinical trials (IND) application review 961, confirmatory clinical application review 3275, new drug applications (NDA) review 690, generic drug applications (ANDA) review 3655. In 2016 to complete an application for registration of the review type mainly for confirmatory clinical applications, ANDA and supplementary application, all kinds of application for registration to complete the review to send bureau number compared with the first three years as shown in the figure 3.
In figure 3, 2016 for all kinds of registration to complete the review board number compared with the first three years
3. The priority review varieties review completed
According to the centre in 2016 human medicinal administration "about addressing drug registration for priority review backlog of examination and approval opinions" (food drug safety medicine tube [2016] no. 19, hereinafter referred to as the no. 19), a total of 12 batches of 193 pieces of registration application should be brought into the priority review program (traditional Chinese medicine (TCM) for 2 pieces, chemical medicine registration application for registration for 169 pieces, biological products registration 22 pieces), as shown in the figure 4. Which has significant clinical value for new drug registration, a total of 85, accounting for 44%.
Figure 4 into priority review procedure of registration
Note:
1. "patents" refers to the no. 19 priority review (a) the scope of examination and approval of 4 kinds of situations, namely "clinical trials of three years prior to the expiry of the patent application and patent application for 1 year prior to the expiry of pharmaceutical production";
2. "synchronous declaration" refers to the no. 19 priority review (a) the scope of examination and approval of 5 kinds of situations, namely "the petitioner in the United States, the European Union synchronous and allowed to carry out drug clinical trial of new drug clinical trial application; use the same production lines in China and in the United States, the European Union and drug examination and approval organization synchronization listing application and through the on-site inspection for drug registration."
By the end of 2016, into the existing 57 in priority review procedures for the registration to complete the review, and another 42 pieces of registration application to complete the review material defect for applicant recover supplement because of personal data, as shown in the figure 5.
Figure 5 into priority review procedure of registration review in 2016
57 a review has been completed in the application for registration of the priority review, there are 11 for proposal approved (including API registration 2 pieces), see table 1.
Table 1 has completed the review proposal approved for priority review registration list
Note: this table does not contain API registration.
(2) drug registration review completion
1. The overall situation
In 2016, the administration of human medicinal center to complete the review and presented for examination and approval of the drug registration, a total of 10060, another 729 pieces for the drug registration to complete the review material defect for applicant recover supplement for personal data. In 2016 to complete the review of the drug registration number compared with the first three years as shown in the figure 6.
Figure 6 in 2016 to complete the review to send bureau for the drug registration number compared with the first three years
In 2016 to complete the review of the medicine for all kinds of registration number as shown in the table 2.
Table 2 in 2016 to complete the review of the medicine for all kinds of registration number (a)
Note:
1. "waiting for additional information" refers to complete the review for defects) filings for an application for registration of the applicant information reply;
2. "withdrawal" refers to the applicant voluntarily apply to withdraw the application for registration, the center of the review of returned to the registration department registration, send equipment review center for YaoXie combination of registration and associated preparations for raw material/accessories registration and withdraw.
In 2016, human medicinal center to complete the review of medicine IND application and application for confirmatory clinical trials, the NDA, the supplement and import registration number from 2015 increased by 37%, 20% and 20% respectively, 67% and 49%. To complete the review to send 2016 innings of the medicine for all kinds of registration number compared with the first three years as shown in the figure 7.
Figure 7 in 2016 to complete the review to send bureau of medicine for all kinds of registration number compared with the first three years
2. Review proposal approval
Recommended in 2016, human medicinal center to complete the review and approval of information.the administration examination and approval of the medicines for all kinds of registration for a total of 6705 pieces, of which about 87% of the registration approved by the 1 round review, review for each wheel through detailed in table 3.
Table 3 in 2016 for the drug registration review for each wheel through the situation
Note:
1. "the review by counting" refers to the administration of the review proposal approval and presented to the approval of registration number;
2. "all round review by (%)" : an application for registration is not carried out additional information for 1 round to complete the review, after an additional information that is for 2 rounds to complete the review, after more than two and additional information for more than three rounds and complete the review. The proportion for the wheel for review by the registration number of the number of the class registration review by percentage.
In 2016, human medicinal center to complete the review proposal approved and presented administration examination and approval of drugs NDA, a total of 23.
In 2016, the center of human medicinal recommended to complete the review of clinical trials of the drug approval IND application for 455, including 316 domestic IND application, international multicenter clinical trial application (including import IND application, similarly hereinafter) 139, therapeutic areas distribution as shown in the figure 8.
Figure 8 to complete the review to send 2016 innings and suggested to approve clinical trials of drug treatment IND application field distribution
To complete the review send proposal approved by the IND application and NDA, proposal approved drug innovation for drug registration 2 pieces (1 species), suggest to approve clinical trials of the drug innovation for drug registration, 255 (91 varieties, including antitumor drug 42 varieties). In 2016 to complete the review to send bureau recommended approval of clinical trials of the drugs for innovative drug registration therapeutic areas distribution see figure 9.
Figure 9 2016 to complete the review to send bureau recommended approval of clinical trials of the drugs for innovative drug registration therapeutic areas distribution (varieties)
Note:
1. Drug innovation medicine refers to the application for registration in accordance with the "drug registration management approach" (formerly the state food and drug administration to 28) the requirements of annex 2 declare the medicine an application for registration of 1.1 and 1.2 and in accordance with the general administration of the work plan for the reform of release chemicals registration classification of announcement (51, 2016) in attachment 1 request to declare the type of drug registration;
2. Due to the condition of the same breed declare multiple indications, so the above all the treatment in the field of total number more than 91 varieties.
(3) of traditional Chinese medicine registration review completion
1. The overall situation
In 2016, the administration of human medicinal center to complete the review and presented to the approval of registration, a total of 1362 pieces of Chinese medicine, and 106 pieces of Chinese medicine registration to complete the review material defect for applicant recover supplement for personal data. In 2016 to complete the review to bureau of traditional Chinese medicine registration number compared with the first three years as shown in the figure 10.
Figure 10 2016 to complete the review to send bureau registration number compared with the first three years of traditional Chinese medicines
In 2016 to complete the review of traditional Chinese medicine for all kinds of registration number as shown in the table 4.
Table 4 in 2016 to complete the review of traditional Chinese medicine for all kinds of registration number (a)
In 2016, human medicinal center to complete the review of traditional Chinese medicine IND application and NDA number are improved, compared with 2015 increased by 161% and 68%, respectively. In 2016 to complete the review to bureau of traditional Chinese medicine for all kinds of registration number compared with the first three years as shown in the figure 11.
Figure 11 to complete the review to send 2016 bureau of traditional Chinese medicine for all kinds of registration number compared with the first three years
Note: the above is not included in the traditional Chinese medicine (TCM) transition legacy varieties.
2. Review proposal approval
In 2016, the center of human medicinal recommended to complete the review and approval of information.the administration examination and approval of all kinds of registration for a total of 230 pieces of Chinese medicine, of which about 38% of the registration is approved by the review 1 round, specific review for each wheel through detailed in table 5.
Table 5 for 2016 Chinese medicine registration review for each wheel through the situation
Approved human medicinal center to complete the review proposal in 2016, administration of clinical trials and presented to the approval of IND application for 84 pieces of Chinese medicine, including respiratory, cardiovascular, digestive and disease of department of gynaecology IND application more, accounted for 65%, the specific therapeutic areas distribution as shown in the figure 12.
Figure 12 to complete the review to send 2016 innings and suggested to approve clinical trials of traditional Chinese medicine treatment field distribution IND application
(4) biological products registration review completion
1. The overall situation
In 2016, the administration of human medicinal center to complete the review and presented for examination and approval of a total of 646 pieces of application for registration of the biological products, and complete the review for defects) filings for reply the applicant for additional information registration, 108. To complete the review to send 2016 innings of biological products registration number compared with the first three years as shown in the figure 13.
Figure 13 2016 to complete the review to send bureau for biological products registration number compared with the first three years
In 2016 to complete the review of biological products for all kinds of registration number as shown in the table 6.
Table 6 in 2016 to complete the review of biological products for all kinds of registration number (a)
Note: "prevention with IND" for preventive biological products IND application, "prevention with NDA for preventive biological products" NDA, "treatment with IND" as the treatment with biological products IND application, "treatment with NDA" for treatment with biological products NDA.
In 2016, human medicinal center to complete the review to the number of biological products for all kinds of registration bureau and the first three years is detailed in figure 14.
Figure 14 2016 to complete the review to bureau of biological products for all kinds of registration number compared with the first three years
2. Review proposal approval
Recommended in 2016, human medicinal center to complete the review and approval of information.the administration examination and approval of biological products of all kinds of registration for a total of 492, of which about 57% of the registration is approved by the review 1 round, specific review for each wheel through detailed in table 7.
Table 7 2016 for biological products registration review for each wheel through the situation
Approved human medicinal center to complete the review proposal in 2016, administration of clinical trials and presented to the approval of biological products IND to apply for a total of 271 pieces, including 30 pieces of preventive biological products IND application, treatment with biological products IND application 241 pieces (treatment with IND application of antitumor drug registration, 109). To complete the review to send bureau and suggested to approve the clinical test of biological products IND application therapeutic areas distribution as shown in the figure 15.
Figure 15 complete review send bureau and recommend approval of clinical trials of biological products IND application field distribution
(5) the review found that the main problems
In 2016, all kinds of registration for research projects design and implementation does not support the application for drug safety, efficacy and quality controllable situation to cause the review conclusion for advice not to approve a total of 2139; For all kinds of registration for the deficiency in the research, first round review conclusion for the additional information of a total of 1654 pieces. The above registration application is not approved, and the cause of the additional information to conduct a comprehensive analysis, combing the various drug registration application in the main problems existing in the course of research and application.
1. The innovation medicine
IND the safety of the prophase study inadequate or insufficient data reliability, insufficient clinical scheme for participants risk control measures or the overall design inadequacy; NDA standardized clinical trials is poor, poor data quality, insufficient clinical trial results reliability. In addition, the NDA filing data information on the production process is not detailed problems are common.
2. The generic
Generic pharmaceutical process, quality standard, the larger defects, stability study shortcomings; Pilot study enough, with the review requirements gap is too big, lead to the applicant fails to finish the additional information or take the initiative to give up the additional information later on down the line.
3. The imported drugs
Declaration of import listed registration data did not provide overseas listing all the research data, the key information is missing, data translation error is more, readability is poor; Import registration approval documents not according to requirements listed again after research.
Second, the drug registration application to accept the situation
(a) to accept the situation as a whole
In 2016, human medicinal center receives the new application for registration for the whole year 3779, down 54% from 2015, and traditional Chinese medicines, chemical medicines and biological products registration receipt, among them the medicine receive maximum amount decreased, a drop of 57%. Registration reception in 2016 compared to the first three years as shown in the figure 16.
Figure 16 registration reception in 2016 compared with the first three years
(2) drug registration to accept the situation
1. The overall situation
In 2016, the new human medicinal center for drug registration to receive 3110 pieces, including ANDA and supplementary application were accounted for 63% of the drug registration receipt throughout the year, as shown in the figure 17.
Figure 17 2016 medicine for all kinds of registration reception
Compared with the previous three years, 2016 medicine for all kinds of registration receipt as a whole is on the decline, the confirmatory clinical trial applications and ANDA affected by the new registration classification receive maximum amount decreased, compared with 2015 fell 80% and 69%, respectively, as shown in the figure 18.
Figure 18 2016 change medicine for all kinds of registration reception compared to the first three years
2. The new classification to accept the situation
Released since the administration on the announcement of chemical classification reform for drug registration scheme (51, 2016) issued and implemented since 2016 human medicinal center 268 receives the new classification for drug registration (excluding the supplement and import registration), including innovation for drug registration (1) 129, modified form for new drug registration (2) 24 pieces, generic drugs registration (new 3, 4 class and class 5.2) 69, the original imported drugs registration (5.1 class) 46 pieces, as shown in the figure 19.
Figure 19 in 2016, a new classification for drug registration reception
Including 1, 129 new generalization for drug registration involved 52 varieties (with active component count, similarly hereinafter), distributed in 11 therapeutic areas, including 20 varieties of antitumor drugs, 12 varieties of diseases of the digestive system drugs.
3. The innovation medicine to accept the situation
In 2016, received the center of human medicinal drug innovation for drug registration (the original, the original 1.2 and 1.1 a new class, similarly hereinafter), 240, a 18% increase over 2015, 212 for domestic registration (77 species), import registration 28 (13 species), as shown in the figure 20.
Figure 20 2016 drug innovation for drug registration reception compared to the first three years
4. The drug clinical trial application indication distribution
In 2016, the center of human medicinal 322 receive the medicine IND application, including domestic IND application for 233, 89 international multicenter clinical trial application. Domestic IND application receipt more for the treatment of anti-tumor drugs, digestive system disease, anti-infection drugs, and skin surgery. International multicenter clinical trial application receipt more for the treatment of anti-tumor drugs, respiratory system diseases and allergy medicines, drugs, blood system diseases, circulatory system disease specific therapeutic areas distribution as shown in the figure 21.
Figure 21 2016 received drug treatment IND application field distribution
(3) of traditional Chinese medicine (TCM) to accept the application for registration
Received traditional Chinese medicine (TCM) in 2016, the center of human medicinal application for registration of 259 pieces, including 33 from IND, the supplement 196, total annual receives 88% of the Chinese medicine, Chinese medicine in 2016 for all kinds of registration reception as shown in the figure 22.
Figure 22 2016 traditional Chinese medicine (TCM) for all kinds of registration reception
Compared with the previous three years, in addition to the import registration again, 2016 traditional Chinese medicine (TCM) for all kinds of registration receipt downward trend on the whole, as shown in the figure 23.
Figure 23 2016, traditional Chinese medicine (TCM) for all kinds of registration reception compared to the first three years
(4) biological products registration to accept the situation
In 2016, 410 human medicinal center received for biological products registration application for registration (including in vitro diagnostic reagent 2 pieces), including the supplement 204, treatment with biological products IND application for 157, 88% of the total amount of biological products for receiving, see figure 24.
Figure 24 2016 biological products for all kinds of registration reception
Note: the above is not included in the in vitro diagnostic reagents application for registration.
In 2016, the biological products for all kinds of registration reception compared to the first three years as shown in the figure 25.
Figure 25 2016 biological products for all kinds of registration reception compared to the first three years
Note: the above is not included in the in vitro diagnostic reagents application for registration.
(5) chemical medicine bioequivalence test (BE) for the record
Since BE put on record platform since opening in 2016, the new declare chemical generics BE put on record the 41 varieties, 16 varieties of generics BE consistency evaluation for the record.
Third, varieties of important therapeutic areas
In 2016, a batch of significant clinical value of innovative medicine, clinical need medicine, patent medicine and China's first imitation medicine to complete the review and advice.
Antitumor drugs:
1. Rui GeFei's piece: for small molecule tyrosine kinase inhibitor, is suitable for the treatment of always received with fluorouracil, and oxaliplatin into Iraq for kang based chemotherapy, and always received or not suitable for accepting resistance against vascular endothelial growth factor receptor, epidermal growth factor receptor drugs in the treatment of wild type (RAS) of patients with metastatic colorectal cancer; Always received imatinib mesylate and malic acid chougny for treatment of locally advanced and unable to surgical resection or metastatic gastrointestinal stromal tumor patients. The drugs for the first is used for small molecules targeting drug for the treatment of advanced colorectal cancer.
2. Mr Azole panitan piece: for vascular endothelial growth factor receptor tyrosine kinase inhibitor, is suitable for the first-line therapy for patients with advanced renal cell carcinoma and have received a cytokine therapy treatment for patients with advanced renal cell carcinoma. Its improved progression-free surial in patients with curative effect and malic acid chougny for similar, similar products in the factors that may affect the quality of life of the security features on the adverse events. The drug approved in China will bring more treatment for patients with advanced renal cell carcinoma.
The treatment 3. Slice: targeted for advanced non-small cell lung cancer with epidermal growth factor receptor's first generation of small molecule tyrosine kinase inhibitors, compared with the traditional chemotherapy efficacy and safety are better, suitable for sensitive with epidermal growth factor receptor mutation of first-line treatment in patients with advanced non-small cell lung cancer. The drug for our country the first medicine, can effectively improve the accessibility of drugs in patients with (the medicine apis for our country the first "marketing authorisation holder system pilot variety").
Anti-infective drugs:
4. Malic acid nai, the effect of capsule: as a kind of cfc-free, quinolones, suitable for nye, the effect of sensitive by staphylococcus aureus, streptococcus pneumoniae, haemophilus influenzae, vice haemophilus influenzae, catarrh mora bacteria, and klebsiella pneumoniae pneumonia mycoplasma, pneumonia chlamydia and eosinophilic lung caused by legionella light, moderate adult (18) or community acquired pneumonia. The medicine can increase the new treatment options for clinic.
5. Fumaric acid baida quinoline piece: for diaryl quinoline mycobacterial drug resistance, its as part of a combined treatment is suitable for the treatment of adult multidrug-resistant tuberculosis (18) or higher. The drugs for the global research and development of nearly 30 years of new anti-tb drugs, for dealing with tuberculosis, a serious public health problem in China provide a new treatment option, is expected to improve the effect of the treatment of multi-drug resistant tuberculosis, meet the demand of clinical treatment of multi-drug resistant tuberculosis patients to reduce the burden of TB disease in our country.
6. Fumaric acid tenofovir two pyrazole cefuroxime ester piece: as the nucleotide reverse transcriptase inhibitors, suitable for combination with other antiretroviral drugs, treatment for adult human immunodeficiency virus type 1 (HIV - 1) infection. The drug is the first copy of the first-line treatment of AIDS drugs, which can effectively improve the accessibility of drugs in patients with, to solve the major public health problem in China is of great significance.
7. Polyethylene glycol interferon alpha 2 b injection: for human recombinant interferon alpha 2 b and formed by the combination of peg-interferon, polyethylene glycol (peg) is suitable for the treatment of adult patients with chronic hepatitis c patients (not in the liver decompensation period). The drug for our country independent research and development of the first long-term interferon, which can effectively improve the accessibility of drugs in patients with.
Rheumatic disease and immune drugs:
8. Joe bead single injection: resistance to humanized monoclonal antibody, with combining with soluble and membrane interleukin - 6 receptor, activation, signal transduction and gene type is suitable for the treatment of systemic juvenile idiopathic arthritis (sJIA), can significantly improve the non-steroidal anti-inflammatory drugs and the lack of systemic glucocorticoid treatment response in patients with active sJIA American rheumatism association rate and reduce the dosage of hormone. The drug, the increasing indications, it is mainly used for pediatric patients, for pediatric patients in our country the first clear treatment efficacy, and safety, solves the problems of clinical medicine available so long.
Endocrine system drugs:
9. Mr That lu peptide injection: sample for glucagon peptide 1 analogues, its amino acid sequence and the same sample glucagon peptide in the human body - 1, have the effect on promoting insulin secretion of glucose concentration dependence, and induce the beta cell differentiation, inhibit glucagon release, gastric emptying and feeding impulse, to improve the sensitivity of insulin receptor, applicable to use metformin efficacy of poor glycemic control in adults with type 2 diabetes. The drug for our country independent research and development of the first sample glucagon peptide 1 class of drugs, will meet in patients with type 2 diabetes in China for such drug accessibility.
Respiratory system diseases and allergy drugs:
10. Golden flower clear sense of particles: as a new traditional Chinese medicine compound preparations, suitable for influenza. The drug is the Beijing municipal people's government in 2009 during the prevention and treatment of influenza a (H1N1), organization of clinical medicine, pharmacy, public health experts in multiple disciplines such as major achievements of science and technology research projects. The drug listing will play a traditional Chinese medicine in health emergency and the positive role of major public health event.
Preventive biological products (vaccine) :
11. 13 price pneumococcal conjugate vaccine: by chemical method combines pneumococcal polysaccharide and protein carrier preparation of glycoprotein combined vaccine, the polysaccharide of T cells rely on immune to T cell dependent, is suitable for the prevention of 6 weeks of age to 15 months infants and young children caused by 13 kinds of pneumococcal serotype invasive disease (including bacteremia pneumonia, meningitis, bacteremia and sepsis, etc.). The drug is China's first listed can be used for babies and infants active immune of 13 pneumococcal vaccine, the price of 7 pneumococcal conjugate vaccine coverage had higher serum type.
Four, the main work measures and progress
(a) to strengthen the construction of the review system
According to guo fa [2015] 44 files and administration requirements, actively promote the review the system construction, clinical efficacy as the core, has been gradually established guidelines in the former, communication in the medium, the review decision after review of the management mode.
One is the system of project manager is progressing satisfactorily. Established nearly 20 people team of project managers, internal management project, work plan, coordinate the review task, indications in the service of the review team; Contact and service, and the applicant organization staff communication meeting, the applicant and the review on improving the professionalism of the review of business management, make the review staff focus on technical review, avoid the review staff contact with the applicant's privately, establish integrity "firewall".
The second is indications team review system preliminary formation. With tumor indications team for the pilot, with clinical efficacy as the core, the clinical, pharmaceutical, pharmacology and toxicology, statistical review of professionals and project management personnel to the review team, implements the more professional review, comprehensive evaluation and the collective decision-making. Strengthen the communication between the various review professional cohesion, strengthen the professional subject construction, clear the referee and the review of power and responsibility, according to the risk size issued by authorized personnel at different levels, improve the review of the scientific and normative.
Three is the communication system produced results. According to the drug research and development and technical evaluation measures for the management of communication (try out) "requirement, in order to promote medicines for innovation, service, has been arranged for innovative drug research and development of communication exchange 122 times. In innovative drug research and development of key link to carry out the communication with the applicant, and review staff communication channels, the open joint research guide to solve difficult problems in research and development and technology doesn't cover the problems, such as drugs, clinical need for innovation research and evaluation to provide support and services.
Four is to establish expert advisory committee and technical system of dispute resolution. In learning from the United States food and drug administration (FDA) on the basis of experience, based on its own, the innovation system, establish the technical evaluation of exploring the major disputes, major problems and special technical problems of mechanism, clear experts publicly reasoning method of dispute resolution. The measures for the administration of the drug registration review expert advisory committee has administration adopted will be examined and approved.
Five is the review information disclosure system steady implementation. Technical guidelines, declare publicly in's official website to set up the column to accept the information such as, the review process, and the result of the review, improve transparency and drug approval work to help the applicant understand the registration filing status, grasp the latest developments in industry research and development, guide the social rational investment and research and development, to avoid low level study, application of repetition. Has openly 12 new drug review report, drafted the pharmaceutical technical evaluation measures for the administration of information disclosure and opinions from the public, will be modified according to the requirements of administration released to the society.
Six is continually push priority review system. To encourage innovation to accelerate has clinical value and the clinical need for drug research and development, the innovation medicine, children's drugs, clinical need medicine, patent medicine and "imitation" has a priority review, develop all kinds of varieties of priority review the selection principles and concrete working procedures, in accordance with the procedure has published 12 batches of priority review directory, 193 applications for registration for the priority review.
(2) strengthen the review of basic work
One is to strengthen the review of technical guidelines and standards system construction. Completed more than 10 a guiding principle of work and revising; In order to promote the review of standards and guidelines system construction work, study to explore the external study commissioned set the operation mode of the guiding principles, a total of 2016 organizations to complete the translation of more than 140 international technical guiding principles, actively carry out foreign regulatory guidelines related research work.
The second is to strengthen the construction of the review the quality management system. Vaccine technology review on December 21, 2016 quality management system through certificated fangyuan group supervision and audit, to obtain ISO9001:2015 version of the certificate; Formulated the "review of the quality management system for human medicinal center", comprehensively launched three years to review the quality management system construction, strengthen the review of the whole process of quality management.
Three is to strengthen the review of development of the information management system. Development builds priority review application subsystem, upgrade chemical medicine BE test record information platform for chemical generics bioequivalence and clinical trial registration platform, increased generics consistency evaluation test record platform. In the website to increase the applicant priority review application, the task of the public module, as well as the feedback content such as drug registration classification reform, strengthen the information technology support, the implementation of network security.
(3) of deepening the reform of personnel system
Set up a chief scientist at the position, the introduction of senior FDA review experts see as chief scientist Dr Meaning; Accelerate the recruitment, personnel scale of nearly 600 people; Innovative personnel training pattern, increase the production of on-site training content; For human medicinal center management system such as part-time review of clinical member; Active exploration project employ flexible way of choose and employ persons; Further human medicinal center in terms of technical evaluation and social cooperation, and xiyuan hospital, Beijing hospital, tsinghua university school of medicine, signed a cooperation agreement.
Five or 2017 key work arrangement
In 2016, the center of human medicinal work has made some progress, but there are still some problems: one is the registration review the backlog of systematic, institutional problem has not fundamentally solve; The second is the review and medicine industry innovation development, transformation and upgrading of the demand is not adapt to; Three is the review of management system and standard system still needs further perfect; Four is the review basic work is still relatively weak, problems left over by history has not been fully resolved.
Human medicinal center will close around 2017 administration work deployment, the key to carry out the following work:
Is a further intensify solve the backlog of drug approval, to ensure that this year completed registration backlog, 2018 time limit the review in accordance with the regulations. Two is around improve review quality, encouraging innovation, increases the transparency of the review, continue to deepen and refine, real priority review, communication, project management team, indications, expert consultation, information disclosure, and establish a review system, etc. Three is to accelerate establishing and perfecting the review quality control system, the technical guide system, compliance management system. Four is to accelerate drug registration check production technology, establish registration platform technology, process change guiding principle, standardize the process change management. Five is to establish record of drug varieties, set up perfect including, prescription drug processing, raw materials, packaging materials, quality standards, specifications, process variation of post-market safety information, production information such as the database. Six is to establish drug electronic universal technical documentation (eCTD) system, for the implementation by the end of chemical generics by eCTD) to receive and review. Seven is to further optimize the internal organization, enhance the level of scientific management; Strict review of personnel management, to strengthen the construction of security system, supervision and administration; To optimize the review career development system.
Is well, will come to. Drug approval system reform has been on the road, human medicinal center will strengthen the confidence, keep in mind the protection and promotion of public health mission, efforts to achieve reform, speed up the construction of an internationally influential review agency, authority, the public trust. |
