Medical network - May 25 from the opinion about drug review of medical equipment examination and approval system reform ", since it was issued all kinds of technical guidelines, draft, policy interpretation of dense, all affects the nerve of the pharmaceutical enterprise. 

 

Held on May 23, the ninth DIA China annual meeting of China on the administration of state food and drug supervision and management of the special performance, for now the industry is most concerned about the drug approval for examination and approval system reform to carry out the situation, the generic drug development, clinical trials evaluating consistency issues such as data verification and the CFDA about guest brings the latest interpretation. 

 

The review reforms revolve around "quality, efficiency, encouragement, transparency" 

 

Li jinju, deputy director of the CFDA pharmaceutical cosmetics registry 

 

Under the state council promulgated the opinions about drug review of medical equipment examination and approval system reform ", after a series of supporting file releasing, summarized up to quality, efficiency, encourage and transparent eight characters. 

 

Improve quality. For evaluation of drugs already on the market to carry out the consistency, a new registration for unlisted drugs classification, set up in accordance with the international advanced level of review concept, in line with international standards for the foundation. 

 

Improve efficiency. We will increase the review and evaluation personnel, establish a mechanism for communication and communication, improve the examination and approval system, and carry out the management of the "BE trial record", and carry out the review and review of the association of medicines and materials and supplementary materials. 

 

Encourage innovation. We will carry out trials of the system for the licensing of drugs to go public, carry out priority examination and approval, and carry out clinical trial data verification. 

 

Transparency. We will strengthen the information disclosure mechanism and launch the electronic technology document eCTD. In the context of strict implementation of the drug registration administration method, the research and development declaration information of the enterprise through the secondary documents is required. 

 

For drug registration is completed jointly by regulatory authorities and enterprises product safety, effective and controllable quality, guide the specification before, and communication in the approval decision after. For enterprises, quality is the foundation of survival, innovation is the path of development and innovation is a painstaking process that requires scientific rigor. We hope that by deepening the reform system, we will make new drug development a new step, so that more Chinese people will be able to use the global new drug early. 

 

The number of varieties of non-289 catalogues is more than that 

 

Xiao hong jie, office of the Chinese food and drug testing institute's generic drug consistency evaluation office 

 

In industry in the generics consistency evaluation problem is more, the reference preparation has become a core concerns, according to the feedback of the enterprise, the reference preparation of controversy has centred on uncertain reference preparations, the availability of reference preparations, the original medicine property whether can be used as a reference preparations on these problems. 

 

As of May 18, we received a total of 5321 reference preparations for the record, jiangsu, shandong, Shanghai, zhejiang, guangdong and other pharmaceutical big province, of which 2018 consistency evaluation must be completed by the end of the 289 varieties of the record number of 2882 pieces, reference preparations for the record the china-africa 289 varieties for far more than 289 varieties. 

 

Consistency evaluation must be completed by the end of 2018, 289 varieties, 232 varieties have been put on record, varieties did not record the main reasons are: part of the varieties is 12 version of basic medicine catalogue of old varieties, market is not much, enterprise small variety development on sales enthusiasm is low, or is the original medicine can not find, and part is a special breed. 

 

According to CDE chemical generics bioequivalence and clinical trial registration information platform, according to the present new chemical generics BE to declare the record 78, consistency evaluation BE put on record 85, clinical equivalence test has successfully for the record. 

 

To BE test resource shortage, there has been a recent clinical trial reform policy, including clinical trial institution qualification from decided to put on record, etc. Now we have the aggregation in the industry for reference preparation and clinical resource related problems reflect to the relevant departments, will organize experts to study after discussion, we can continue to focus on the latest progress. 

 

Gradually implement various registration applications according to the time limit review 

 

CFDA's center for drug review and evaluation is in huangqingzhu 

 

In order to further implement the reform of the review and evaluation system of medicines, and to solve the drug backlog, we mainly focus on the following five issues: 

 

Indications team review system. Set according to the indications review organization, form the clinical review personnel as the core, pharmacology, toxicology, pharmacology, statistics and other professional review of the review team together with the project manager. The implementation of multiple professional reviews, comprehensive evaluation and collective decision making, and the responsibility of the assessor and the assessor, and the issuance of the appraisals according to the risk authorization. We will strengthen the construction of various professional disciplines. 

 

Establish the project manager team. To organize and coordinate the review and evaluation of medicines, coordinate the internal and external services, and serve the evaluation team and the applicant. The reviewer focuses on the technical review and the project manager focuses on coordination and communication. We will improve the efficiency of review organizations and communication and communication, and exercise a "firewall" of oversight and integrity. 

 

Priority review. Has clinical value of innovative medicine and urgent clinical needs of generic implementation of priority review, to speed up the approval of product, so far has 261 to apply for priority review. In the future, we will consider the normalization of priority over the gradual settlement of the backlog. 

 

Communication system. Issued the drug research and development and technical evaluation communication management approach (trial) ", the key to solve the difficulty of the applicant, the problems and technical guide is not covered. The development and evaluation of research and evaluation were strengthened, and the technical support was provided for the development and evaluation of innovative drugs and the urgent need for drugs. Set up general technical problems consulting work system, timely and accurate feedback, improve the quality and efficiency of consulting work. 

 

Expert advisory committee system. We will safeguard the scientific and justice of drug approval, improve the transparency of the review and evaluation of medicines, and improve the quality control system. 

 

Time limit for the next step we will gradually achieve various registration according to the review, through various reform measures to ensure that the landing will not produce new backlog, 2020 to 2020 years to build a complete professional, reasonable configuration, to meet the needs of the public administration and industrial development needs the review team and examination and approval system. 

 

The most common problems with data verification are the records of the test procedure and the source of the analysis 

 

Dong jiangping, deputy director of the CFDA food and drug review and inspection center 

 

According to "the four most strict requirements," state administration organizations to carry out the drug clinical trial data verification, as of May 2017, the verification center a total of 1989 varieties in the check tasks, already check 284 varieties, 1204 varieties have been withdrawn. Clinical trials to check around the main two aspects of clinical and biological samples analysis, found that most of the problem is that the clinical trial process records and test data, accounting for almost 30% of the overall problem, other also includes the test drug management and records, the results back, biological samples, etc. 

 

The food and drug audit inspection center will be more efforts to accelerate the clinical trial data verification and progress, according to the work plan, to ensure completed by the end of June, 2017 administration of the state food and drug supervision and administration committee of the CCP party bulletin on patrol rectification of the drug clinical trial data verification work. We will further improve the procedures for inspecting inspections, make detailed verification plans, review and write requirements, strengthen the management of the review committee, and improve the mechanism for communication. We will improve the technical standards for on-site inspection, integrate with international standards, improve on-site inspection quality, and unify the inspection scale. Maintain open and transparent working style, accept the supervision of the parties to the data verification work, strengthen the information disclosure work, expand public content and scope, and improve the quality of information disclosure. 

 

In the field of pharmaceutical production circulation, audit inspection center in 2016, the food and drug inspection involves varieties of 431 a and send inspector 1277 person-time, include the production field of drug quality inspection, the inspection of GMP certification, GMP track inspection, drug flight check, imported drugs overseas production on-site inspection, medicine circulation check seven classes such as check item. 

 

In 2017, the food and drug audit inspection center will strengthen team construction, improve relevant laws and regulations, set up the behavior the bottom line, let the inspection according to the can depend on, with the industry to promote drug research and development, production, circulation, use environment purification, on the other hand, to strengthen communication and exchanges with foreign industry experts, promote industry standards, further promote the legalization of inspections, scientific, standardization and internationalization.