Policy article on the great medical event in April
Last Update: 2021-03-02
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Most of the pharmaceutical policies issued in April related to pharmaceutical and medical insurance, such as the Measures for the Administration of the National List of Shortage Drugs (Trial); These policies will further safeguard the people's demand for drugs, stabilize drug prices, and raise the level of medical security in China.
the Measures for the Administration of the National List of Shortage Drugs (Trial)
At the end of April, the State Health and Safety Commission issued the Measures for the Administration of the National List of Shortage Drugs (Trial), which totalled 14 measures. Measures for the shortage of drugs, clinically necessary drugs to make a detailed definition, to China's shortage of drugs to implement the list management system provides a basis for the formulation, but also clearly defined the national list of drugs in short supply and clinically necessary drugs in short supply of key monitoring list of the formulation of principles, procedures and transfer principles.
In addition, it is emphasized that the State will strengthen monitoring and early warning, strengthen normal supervision of prices, increase enforcement of illegal acts such as monopoly of raw material drugs, and properly deal with the problem of excessive price increases in drugs.
the 25th and 26th batches of generic pharmaceutical ginseng preparations issued
In mid-April, the State Drug Administration in a row 25th and 26th batch of generic drug ginseng preparations, involving 177 varieties, 343 product regulations. Specifically includes 53 varieties of injections, 97 product regulations, tablets 55 varieties, 130 product regulations, and dry suspension agents, capsules, oral solutions, inhalation powder mist, eye preparations, patches and other 69 varieties, 110 regulations.
The industry believes that, with the publication of generic drug ginseng preparations, the relevant product market competition will enter a new stage, at the same time in the three medical linkage, volume procurement and other policies, the future will be a large number of generic drugs eliminated.
to liberalize the first diagnosis into internet health care, health care
In April, "On the promotion of "on the cloud with a number of wisdom" action to cultivate new economic development implementation program" issued, the article focused on "to the national digital economic innovation and development pilot area as a carrier, in the field of health and health to explore the promotion of Internet medical insurance first consultation system and appointment of the three-diagnosis system, the development of Internet medical insurance settlement, payment standards, drug online sales, graded diagnosis and treatment, remote consultation, multi-point practice, family doctors, online ecological circle consultation and other reform pilot. "
is the first time that the first consultation has been proposed at the national level to be incorporated into Internet health care and health care. The policy is widely seen in the industry as crucial to the future development of Internet healthcare.
9 drugs are converted from prescription to over-
At the end of April, the State Drug Administration issued a notice on the conversion of eight drugs, such as ivethero softgels, into over-the-counter drugs, and converted eight drugs, such as ivethero softgels, from prescription to over-the-counter. At the same time, the National Drug Administration issued a notice on the conversion of prescription drugs into over-the-counter drugs and the revision of over-the-counter prescription drug instructions, the conversion of silver pills from prescription drugs to over-the-counter drugs and the revision of over-the-counter drug instructions.
It is understood that drugs from prescription drugs to over-the-counter drugs, generally need long-term accumulation of clinical data to prove that the drug in the over-the-counter drug sales model will not appear related safety issues. As the nine drugs were converted from prescription to over-the-counter, it meant that their circulation channels, advertising and other forms were more diverse. According to the industry, "after switching to over-the-counter drugs, there is a good chance that sales of the variety will be released, but it will also depend on how the company markets".
revised version of the Code of Quality Management for Drug Clinical Trials
On April 26, the State Drug Administration and the National Health And Safety Commission issued a revised Code of Quality Management for Drug Clinical Trials (No. 57 of 2020), which includes: Quality Management Practices for Drug Clinical Trials, terminology and definitions, as well as what researchers and bidders should do. The new code will come into effect on July 1, 2020. The aim is to deepen the reform of the drug review and approval system, encourage innovation, and further promote the normative research and quality of drug clinical trials in China.
"Guidelines on the Establishment of a Credit Evaluation System for Drug Prices and Recruitment (Draft for Comments)" issued
At the end of April, the State Health Insurance Administration solicited "guidance on the establishment of drug prices and credit evaluation system (draft for comments)" issued, the "opinion" was issued in order to curb the recent years in the pharmaceutical sector commercial bribery, market manipulation and other acts caused by the inflated prices of drugs, medical costs too fast growth, a large number of loss of health insurance funds, such as serious harm to the safety of health insurance funds.
health insurance bureau issued the Interim Measures for the Administration of Basic Medical Insurance Drug Use (Draft for Comments)
On April 29, the State Administration of Medical Security issued the Interim Measures for the Administration of Basic Medical Insurance Drugs (Draft for Comments) for public consultation. Chapter II of the draft for comments clearly defines the conditions for the transfer out of the Drug Catalog. Among them, a batch of drugs will be directly transferred out of the Drug Catalog. Specifically, there are 6 categories of cases: drugs that have been revoked, revoked or cancelled by the drug regulatory authorities, drugs that have been prohibited from being produced, sold and used by the relevant departments, drugs that have been placed on negative lists by relevant departments and institutions, drugs that have been assessed to be more risky than beneficial after taking into account such factors as clinical value, adverse reactions and drug economy, drugs that have been assessed to be more risky than gain; drugs that have entered the Drug Catalog by means of fraud and other illegal means; and other cases that should be directly transferred by the State.
the State Drug Administration revised the appendix to the Biologics
On April 23, the State Drug Administration issued a revised version of the Appendix to the Code of Quality Management of Pharmaceutical Production (revised in 2010). In accordance with Article 310 of the Code of Quality Management of Pharmaceutical Production (revised in 2010), the State Drug Administration has revised the appendix to the Biological Products and is now publishing it as a supporting document of the Code of Quality Management for Pharmaceutical Production (revised in 2010). This Appendix will take effect from 1 July 2020.
Among them, for Appendix Article 59, enterprises using real-time data collection information system to record data, because the information construction needs a certain period, should meet the relevant requirements by July 1, 2022.
the Notice on the Adjustment of Basic Pensions for Retirees by 2020
On April 10, the Ministry of Human and Social Affairs and the Ministry of Finance officially issued a document to adjust the basic pension level of retirees from January 1, 2020. In terms of the level of adjustment, the overall national adjustment ratio is based on 5% of the monthly basic pension for retirees in 2019. The provinces determine the adjustment ratio and level of the province with the national overall adjustment ratio as the high limit.
three standards, such as the Medical Security Information Platform Cloud Computing Platform Specification, were issued
On April 24, the National Health Insurance Administration forwarded a notice on the issuance of three standards, including the Code of Cloud Computing Platform for Medical Security Information Platforms.
In order to carry out the overall deployment of medical security information construction and the general requirements of the National Medical Security Information Construction and the Guidance of the National Medical Security Information Work, guide and standardize the information construction of medical security in various places, and build a national unified, efficient, compatible, convenient and safe medical security information platform with high standards, three standards have been formulated: Medical Security Information Platform Cloud Computing Platform Specification, Medical Security Information Platform Application System Technical Architecture Code, Medical Security Information Platform User Interface Code, and are now issued and required to comply with the implementation.
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