Policy of major medical events in November: focusing on standardization to boost the healthy development of the industry

National Medical Insurance Bureau issued the "operation standard of medical price and bidding and purchasing credit evaluation (2020 Edition)"

Recently, the State Medical Insurance Bureau issued the "operating standards for medical price and bidding and purchasing credit evaluation (2020 Edition)" (hereinafter referred to as "operation specifications"). Specifically, the "operation specifications" is divided into eight parts, including the principles of credit evaluation system, the list of credit evaluation catalogue, the implementation of the enterprise's promise of keeping faith, the collection and recording of dishonest information, the credit rating of dishonest behavior, the hierarchical disposal of responsibility, and the pharmaceutical enterprises There are regulations on credit restoration and information construction of credit evaluation system. The industry believes that the establishment of credit evaluation system is based on the free entry and exit of pharmaceutical enterprises in the centralized procurement market, and the red line and bottom line set by the medical security department and the market for relevant enterprises, which will play a crucial role in the future standardized development of medical equipment industry.

Supervision and management measures for drug online sales (Draft for Soliciting Opinions)

On November 12, the comprehensive Department of the State Food and Drug Administration (SFDA) publicly solicited the "measures for the supervision and administration of online drug sales (Draft)", pointing out the direction of online sales of prescription drugs. The draft is divided into 6 chapters and 48 articles. The document clearly stipulates the supervision of drug online sales from the aspects of drug online sellers, online sales scope, online sellers' obligations, third-party platform management, drug distribution, legal responsibility, etc.

Promoting the payment of medical insurance for Internet plus medical services

In November 2nd, the national health insurance agency issued the "guidance on the work of medical insurance payment for Internet plus" medical services by the national health insurance agency. The suggestion points out that the designated medical institutions provide the "Internet plus" medical revisit service that meets the prescribed regulations, and charge and pay according to the price of general outpatient clinics in public hospitals. The drug expenses incurred shall be paid according to the payment standards and policies stipulated by the offline medical insurance. The industry believes that the introduction of the document reflects the further support of the state for pharmaceutical e-commerce and Internet medicine, and will also bring obvious benefits to the development of internet medical enterprises, off hospital prescription drug market sales, DTP and other professional prescription pharmacies.

Technical guidelines for pharmaceutical research in different stages of new drug research of traditional Chinese medicine (Trial)

On November 4, the website of the drug evaluation center of the State Drug Administration released the technical guidelines for pharmaceutical research in various stages of new Chinese Medicine Research (Trial), which will be implemented from November 4, 2020. It is generally believed that the formal implementation of the guiding principles will fill a big gap in the research and development of new Chinese medicine in China, and help to further improve the quality of domestic traditional Chinese medicine.

Notice on standardizing the allocation and use of licensed pharmacists in pharmaceutical retail enterprises

On November 20, the State Food and Drug Administration officially issued the notice on standardizing the allocation and use of licensed pharmacists in drug retail enterprises (hereinafter referred to as the notice). According to the notice, in view of the actual situation that licensed pharmacists are not enough and difficult to equip in some regions, the provincial drug supervision and administration departments can formulate and implement the policy of differentiated allocation and use of licensed pharmacists without reducing the overall proportion of licensed pharmacists, and set up a transitional period; during the transitional period, for regions with obvious gaps in licensed pharmacists, the provincial drug supervision and administration departments can formulate and implement the policy of differentiated allocation and use of licensed pharmacists, and set up a transitional period, Drug retail enterprises are allowed to provide other pharmaceutical technical personnel to undertake the responsibilities of licensed pharmacists, and the transition period shall not exceed 2025. The notice shall come into effect on January 1, 2021.

Guidelines for adverse event risk assessment of medical device registrants

On November 27, the State Food and Drug Administration issued a notice on guiding principles for medical device registrants to carry out product adverse event risk assessment. The document was issued to standardize and guide medical device registrants to carry out post marketing risk assessment of medical devices. A large number of medical devices are considered or influenced by the industry.