On July 6, the reform of the review and approval of pharmaceutical medical devices was further deepened, and the recent reform measures had a significant impact on the industrial ecology.
On the morning of July 5, in the 12th annual meeting and 2017 national pharmacy of Chinese pharmaceutical industry top week, the administration of state food and drug supervision and administration of drugs to change registration division officials at the conference entitled "deepening the reform of drug approval for examination and approval, encourage pharmaceutical medical equipment innovation" of the keynote speech, this paper introduces the reform of the latest progress for examination and approval of drug approval.
In August 2015, the state council issued the "opinions on the reform of the examination and approval system for pharmaceutical medical devices", and the reform was officially opened. The core of reform is to improve the quality of drugs, to realize the effectiveness, safety and quality control of listed drugs through reform, so as to meet the international advanced standards and meet the needs of public medicine.
Initial effect
The overall goal of reform is to improve quality, improve efficiency, encourage innovation and transparency. "Improving the quality of clinical outcomes is the main responsibility of the enterprise and the focus of regulation." In order to improve the effectiveness of the drug, the general administration has raised the standard of drug approval, implemented the reform of the classification of drug registration, and carried out the generic drug consistency evaluation, the official said. In order to get the people to use the best medicine early, the examination and approval efficiency improvement is quite important. Through the reform of the personnel and financial system of the pharmaceutical audit center, the number of drug review and approval teams has been increased from more than 200 in early 2015 to 600 now. In order to encourage innovation better, we have launched a pilot scheme to carry out drug listing permit holders in 10 provinces. It has been revealed that the current pilot of listed license holders is summarizing experience and striving to push it out as soon as possible.
"Transparency" is one of the key points of reform in order to ensure fair and equitable drug review and approval. Through information disclosure, electronic declaration (CTD, eCTD), progress query, etc., "relevant information can not only be inquired by the counterpart, but also open to the public."
It is reported that the reform has achieved certain results. The number of drug registrations has also fallen from 22,000 in 2015 to nearly 6,000. At the same time, the evaluation of conformance is also carried out in an orderly manner. The state administration of state has issued 10 policy documents and 5 technical guidelines in succession, which have received more than 4000 reference materials for reference. And encourage innovation orientation have the initial results, the price of 13 pneumococcal conjugate vaccine, bei that lu peptide injection, fumaric acid tenofovir two pyrazole cefuroxime ester, bei da quinoline fumaric acid, malic acid, the treatment effect, so a batch of drugs into the market.
The new initiative focuses on innovation
In may this year, in order to further deepen the reform, the state administration of coordinated the related departments of the state council, publish four advice, focus on encouraging drug medical equipment innovation, puts forward a package of reforms, the society for public opinion. The above draft mainly focus in the reform of clinical trial management, implementation of the drug in whole life cycle of medical equipment management, promote the development of pharmaceutical innovation and generics, purify the drug research and development of ecological environment, to speed up the new medical equipment listed for examination and approval of the review and improve technical support power for examination and approval of review.
The reporter learned from the meeting, in order to promote innovation and development of generic drugs, drug administration of the country is in conjunction with the relevant departments, to explore new ideas: one is to establish drugs listed directory set, approved medicines included in the directory set in China, indicating the active ingredients, dosage form, specification, patent holder, and other information; The second is to explore the establishment of a drug-related professional link system, which will be linked to the examination and approval of generic drugs, and the examination and approval decisions of the appraisal agencies according to judicial decisions; Third, we will explore the establishment of a patent term compensation system for medicines, and compensate for the appropriate patent term for the delay of the examination and approval and the delay of the clinical trial. Four is to improve drug test data protection system, the future will gradually open test data, but the innovation medicine, rare diseases, children decongestion, innovative drug treatment with biological products offer certain data protection, data protection during the period of don't approve other applicants with varieties listed; Five is to improve drug patents expire generic production, release the drug patent protection expire without generics apply for listing, support biological similar drugs, generic YaoXie combination of clinical value products. In addition, it will also implement the confidentiality obligations of state functionaries, and the review and approval inspection and approval inspection personnel shall have a confidentiality obligation.
About earlier, it seems to the head of a drug clinical trial data check list for verification, with "the most rigorous standards, strict regulation, the most severe punishment, the most serious accountability" four "the most severe" to request, investigate clinical trial data frauds, for our country to purify drug development to lay a good foundation for the ecological environment.
In order to make new drug innovation and regulation more effective, improve technical review and approval support ability. The state administration of state administration is strengthening the capacity building for review and review, and adopting the government's purchase of services to expand the evaluation force, establish the eCTD system and improve the efficiency of the appraisal. The testing system for drug clinical trials shall be reformed, and the test samples of clinical trials may be inspected by the applicant or commissioned by the pharmaceutical inspection institution. The state administration of state is responsible for the inspection of the pre-listing. The provincial bureau is responsible for the inspection of the production process after the listing. The municipal bureau is responsible for the inspection of the operation process. Build professional inspection team, implement the supervision of inspectors, strengthen training, and strengthen equipment. It also strengthens international cooperation, participates in international rules and standards revision, and gradually realizes international sharing of inspection and inspection standards and results.
"Any one of these policies can't be implemented without an industry." The chief said the industry should understand national policies, enforce national regulations and work together to create a better environment.
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