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Home > News > Policies > In 2021, a large number of new pharmaceutical policies may be implemented

In 2021, a large number of new pharmaceutical policies may be implemented

ECHEMI 2021-03-09

As major companies start production after the holiday, 2021 will usher in a brand new look. It is reported that in 2021, many new policies related to the field of medicine and health will also be intensively implemented. These policies may have a major impact on the field of medicine and health and people's lives.

 

From next month, the "2020 Drug Catalog" will be implemented

 

The "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2020)" will be officially implemented from March 1, 2021. It is understood that the "2020 Drug Catalog" contains a total of 2,800 types of Western medicines and proprietary Chinese medicines, including 1,264 types of Western medicines, 1,315 types of Chinese patent medicines, and 221 types of drugs negotiated during the agreement period. In addition, there are 892 kinds of Chinese medicine decoction pieces that the fund can pay.

 

The pilot work of traditional Chinese medicine formula granules will be terminated from November

 

On February 10th, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine, the National Health Commission and the National Medical Insurance Administration jointly issued the "Announcement on Ending the Pilot Work of Traditional Chinese Medicine Formula Granules", announcing the pilot work of traditional Chinese medicine prescription granules that has continued from 1993 to the present. , Will face termination on November 1, 2021. The announcement is clear: Chinese medicine formula granules "implement record management, do not implement approval number management", and manufacturers only need to file with the local provincial drug regulatory department.

 

In other words, in the future, all traditional Chinese medicine companies can produce traditional Chinese medicine formula granules without applying for an approval number, but only need to file for the record. Moreover, the State Food and Drug Administration's regulations on the distribution and reimbursement of TCM formula granules are the same as those of TCM decoction pieces, and the TCM formula granules included in the local medical insurance reimbursement scope shall be managed in accordance with the medical insurance category B management.

 

Before the end of 2021, my country will realize cross-province social security cards

 

Before the end of 2021, my country will realize the cross-provincial administration of social security card application, activation, replacement, temporary loss and other service matters. Key information such as the social security number and name of the social security card can be read across the country. No matter which province the social security card is applied for, the information in it can be read through the machine in other provinces. The relevant person in charge of the National Medical Security Bureau previously stated at the press conference of the State Council Information Office that by the end of 2021, six inter-provincial service items will be realized for settlement and filing of medical treatment in different places and direct settlement of outpatient expenses across provinces.

 

DRG and DIP pilot areas will enter the actual payment stage by the end of 2021

 

At the level of medical insurance payment reform, after the formulation of the DRG (Diagnosis-related Group Payment) top-level plan and grouping plan in 2019, the simulation operation phase of 30 pilot cities will be entered in 2020, and non-pilot areas are also eager to try local exploration and practice. .

 

DRG is followed by the pilot of DIP (Payment by Disease Score) payment method. 71 cities are included in the pilot cities, and a list of 200 DIP experts has been announced. The state plans to carry out the pilot work in the prefecture-level city overall planning area. It will take 1-2 years to combine the overall planning of the regional medical insurance budget with the point method to achieve a multiple compound payment method that mainly pays according to disease points for hospitalization. By the end of 2021, all pilot areas will enter the actual payment stage.

 

CDE biopharmaceutical "consistency evaluation" rules are here

 

On February 18, the Drug Evaluation Center of the State Drug Administration issued the "Technical Guidelines for the Evaluation of Similarity of Biosimilar Drugs and the Extrapolation of Indications", which will be implemented from the date of issuance. This means that my country has put forward clear regulatory requirements for the development and marketing of biosimilar products. At the same time, people in the industry generally believe that the above-mentioned principles are the "consistency evaluation" policy for biosimilar products in my country. The introduction of this policy has brought the volume purchase of biosimilars one step closer.

Disclaimer: ECHEMI reserves the right of final explanation and revision for all the information.

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