In April, the National Healthcare Security Administration, the National Medical Products Administration, and other relevant departments issued new policies and regulations pertaining to the pharmaceutical industry, covering areas such as DRG reform, pharmacovigilance inspections, and traditional Chinese medicine. The author has provided a brief overview of these developments, intended solely for industry reference.
The National Healthcare Security Administration Issues New Notice on DRG Reform Innovations
On April 15, 2022, the National Healthcare Security Administration issued the "Notice on Coordinating the Implementation of DRG/DIP Functional Modules in the Payment Method Management Subsystem" (hereinafter referred to as the "Notice"). According to the timeline outlined, starting from April 2022, selected provincial-level medical insurance information platforms will undergo testing. These platforms will adjust relevant rules, parameters, transmission protocols, usage procedures, and security measures based on local data and in alignment with the technical specifications for DRG/DIP. By the end of June 2022, a limited number of regions newly implementing DRG/DIP payment reform initiatives will begin piloting the nationally unified DRG/DIP functional modules within the national medical insurance information platform. By the end of November 2022, the DRG/DIP functional modules are expected to be fully operational across the country.
Industry insiders pointed out that this model helps drive hospitals toward more refined management and the rational allocation of medical insurance funds. Under the impetus of this reform, pharmaceutical companies need to undergo transformations in their marketing strategies, product portfolios, and even R&D orientations.
The National Medical Products Administration Releases Guidelines for Pharmacovigilance Inspections
On April 15, the National Medical Products Administration (NMPA) released the "Guiding Principles for Pharmacovigilance Inspections" (hereinafter referred to as the "Guiding Principles"), aimed at providing guidance for drug regulatory authorities in conducting pharmacovigilance inspection activities. The principles emphasize risk management and strengthen risk control measures. They cover key considerations for inspections, inspection methods, critical inspection points, and other relevant aspects. Additionally, the guidelines define defect risk levels and assessment criteria, while also specifying 100 mandatory inspection items.
The National Medical Products Administration has issued the "Regulations on the Management of Annual Drug Reports."
On April 12, the National Medical Products Administration (NMPA) issued a notice announcing the release of the "Regulations on the Management of Annual Drug Reports." The annual drug reporting system is a new mechanism introduced under the revised Drug Administration Law. In addition to formulating the "Regulations on the Management of Annual Drug Reports" and the "Annual Drug Report Template," the NMPA has also developed an annual drug report collection module, which was launched simultaneously.
The annual drug reporting module is divided into an enterprise-side and a regulatory-side component. The enterprise-side collects information covering two main areas: the public section and the product section.
The public section includes six key aspects: holder information, overall status of held products, an overview of quality management, details on the establishment and operation of the pharmacovigilance system, instances of accepting overseas contract manufacturing arrangements, and records of inspections conducted by foreign drug regulatory authorities.
The product section comprises four key components: fundamental product information, production and sales data, post-marketing research and change management activities, and risk management measures.
The National Healthcare Security Administration has issued the "Notice on Printing and Distributing the '14th Five-Year' Action Plan for Enhancing Basic-Level Traditional Chinese Medicine Service Capabilities."
On April 7, the National Healthcare Security Administration issued the "Notice on Printing and Distributing the '14th Five-Year' Action Plan for Enhancing Basic-Level Traditional Chinese Medicine (TCM) Service Capacity." The notice clearly states that by 2025, a more robust basic-level TCM service network integrating preventive healthcare, disease treatment, and rehabilitation will be established. This network will feature improved service facilities and equipment, more rational staffing arrangements, and enhanced management practices. As a result, comprehensive TCM services covering the entire population and all stages of life will be delivered, significantly boosting TCM service capabilities. This will effectively meet the growing demand for TCM services among urban and rural residents, providing strong TCM support to achieve the goal of addressing common illnesses at the city and county levels, while managing everyday health issues at the grassroots level.
The specific goal is to achieve five "full coverage" initiatives for grassroots traditional Chinese medicine by 2025:
1. Basic full coverage of county-level TCM medical institutions (hospitals, outpatient clinics, and clinics);
2. Full coverage of TCM clinics in community health service centers and township health centers;
3. Basic full coverage of TCM service provision at the grassroots level;
4. Basic full coverage of TCM personnel allocation at the grassroots level;
5. Full coverage of TCM health education and promotion activities at the grassroots level.
