Medical Policies Weekly
On December 3, The National Healthcare Security Administration and the Ministry of Human Resources and Social Security issued the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)", which will be officially implemented on January 1, 2022. In this adjustment, a total of 117 drugs were negotiated, 94 of which were successfully negotiated, and the overall success rate was 80.34%. Among them, the 85 exclusive drugs outside the catalog reached 67, with a success rate of 78.82% and an average price reduction of 61.71%. A total of 74 drugs were added to the catalog and 11 drugs were removed from the catalog. The 74 new drugs outside the catalog involve 21 clinical groups, including 20 drugs for chronic diseases such as hypertension, diabetes, hyperlipidemia, and psychosis, 18 drugs for tumors, 15 drugs for hepatitis C and AIDS, and 7 drugs for rare diseases, 2 drugs for the treatment of new coronary pneumonia, and 12 drugs for other fields, and patients benefit from a wide range. Eleven drugs have been removed from the catalog, all of which have low clinical value and are replaceable, or have been purchased in a small amount on the national recruitment platform in recent years. After the adjustment, the total number of drugs in the National Medical Insurance Drug List is 2,860, of which 1,486 are Western medicines and 1,374 are Chinese patent medicines. The number of Chinese herbal medicines in the catalog has not been adjusted, and there are still 892.
CDE issued three Guidelines for Gene Therapy
In order to standardize the research and development of gene therapy products, CDE issued three guidelines related to gene therapy on December 3, which will be implemented from the date of issuance.
"Technical Guidelines for Long-term Follow-up Clinical Research of Gene Therapy Products (Trial)", which mainly includes three aspects: overview, design of long-term follow-up clinical research for gene therapy, and recommendations for the implementation of long-term monitoring plans after marketing. Applicable to products with gene therapy attributes that are developed and registered in accordance with the relevant regulations of drug management, such as plasmid DNA, RNA, genetically modified viruses, bacteria or cells, and products based on gene editing technology etc.
"Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products (Trial)", which mainly includes three aspects: introduction, non-clinical research, and non-clinical considerations supporting clinical trials. It is applicable to gene therapy products other than genetically modified cells. It is not applicable for chemically synthesized oligonucleotides and their analogues and preventive vaccines.
"Technical Guidelines for Non-clinical Research of Gene Modified Cell Therapy Products (Trial)", mainly including nine parts: introduction, scope of application, overall considerations, test substance, animal species/model selection, non-clinical validity and proof of concept, non-clinical pharmacokinetics, non-clinical safety, and special considerations for specific types of genetically modified cell products, which are applicable to genetically modified cell therapy products.
In order to implement the “Pharmaceutical Administration Law of the People’s Republic of China” and the “Vaccine Administration Law of the People’s Republic of China”, and to guide the drug regulatory authorities to carry out pharmacovigilance inspections in a standardized manner, the Comprehensive Department of NMPA publicly solicits opinions on the "Guidelines of Pharmacovigilance Inspection (Draft for Comments)"on December 1. The time limit for soliciting comments is December 31, 2021. The main content of the guidelines includes six parts: key consideration factors for routine inspections, key consideration factors for due inspections, inspection methods, inspection locations, defect risk levels, and evaluation standards.
