Medical Policies Weekly ( Issue 21，2020）
1、The National Healthcare Security Administration (NHSA) of the People's Republic of China issued Work Plans and Reporting Guidelines for the Adjustment of Medical Insurance Directory in 2020.
After soliciting public opinions in the early stage, the NHSA recently issued Work Plans on the Adjustment of Medical Insurance Directory in 2020 and Reporting Guidelines for the Adjustment of Medical Insurance Directory in 2020. According to the work plan on the adjustment of the Medical Insurance Directory, the scope of the adjustment for drug catalogues in 2020 includes: western medicines and Chinese patent medicines outside the catalogue, covering seven cases of drugs to be added including the drugs used for treatment of COVID-19 related respiratory diseases; western medicine and Chinese patent medicine inside the catalogue, covering the scope of 2 kinds of drugs out of the catalogue and 3 kinds of drugs in the adjustment for standard of payment; others include inclusion of qualified TCM readymade slices in the adjustment scope according to regulations, improvement in the notes on the drug catalogues, standardization of drug name and dosage forms, and appropriate adjustment of the classification of drug category A and B, classification structure of the catalogues, remarks and other contents.
2、The CDE issued announcement of five guiding principles including Technical Guidelines for Novel Coronavirus Prophylactic Vaccine Development (Trial)
On August 14th, the CDE issued five guidelines: Technical Guidelines for Novel Coronavirus Prophylactic Vaccine Development (Trial), Technical Guidelines for Novel Coronavirus Prophylactic mRNA Vaccine Pharmaceutical Research (Trial), Technical Points about Study and Evaluation on Non-clinical Efficacy of Novel Coronavirus Prophylactic Vaccine (Trial), Technical Guidelines for Clinical Research on Novel Coronavirus Prophylactic Vaccine (Trial), Clinical Evaluation Guidelines for Novel Coronavirus Prophylactic Vaccine (Trial), with the purpose of providing technical standards on clinical research and development of COVID-19 vaccines in China for reference and promoting the listing process of COVID-19 vaccines.
3、The CDE issued a number of draft technical guidelines for comments.
（1）The contents of Guidelines for the Design of Clinical Trials of Oncolytic Virus (OV) Medicines (Draft for Comments) include overview, key points of clinical trial design and risk control. As for the key points of clinical trial design, such aspects as exploratory study, efficacy evaluation, safety evaluation and follow-up of subjects, drug regimen, pharmacokinetics and immunogenicity of exploratory and confirmatory clinical trials which are operated on OV medicines are expatiated. The risk control part of the clinical trial process reminds applicants to develop control measures for biosafety risks that may arise from the specific biological characteristics of OV medicines.
（2）The contents of Technical Guidelines for Clinical Trials of Drugs for the Treatment of Dyslipidaemia (Draft for Comments) include: the scope of application expounds that the guidelines apply to the development of chemical medicines and therapeutic biological products; the overview mainly introduces background content such as the concept of dyslipidemia, the risk of dyslipidemia, and the main purpose of lipid-modulating therapy; the overall considerations of clinical development are expounded from such three aspects as clinical pharmacology research, exploratory clinical trial and confirmatory clinical trial; as for the key elements of clinical trial design, the key contents to focus on of each element are elucidated respectively from such aspects as study population, selection of the controls, dose selection, introduction period, research period, validity index and security index.
（3）As for draft Q&A documents and their supporting documents of ICH M7 Assessment and Control of DNA Reactive (mutagenic) Impurities in Drugs to Limit Potential Carcinogenic Risk, the draft Q&A document is now in Phase Three, namely regional public comment period. In accordance with the requirements of relevant regulations by ICH, regulatory body members of ICH need to gather local guidelines for Phase 2B / comments on draft Q&A documents and give feedbacks to ICH.
（4）Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilar Drugs (Draft for Comments) aims to raise instructional suggestions for similarity evaluation and indication extrapolation of biosimilar drugs. The similarity evaluation part is expatiated from the aspects including the general consideration, pharmaceutical similarity, non-clinical similarity, clinical similarity and overall similarity. In the part of indication extrapolation, general conditions, conditions for indication extrapolation and comprehensive evaluation are stated.
（5）Technical guidelines for Bioequivalence study include: Technical Guidelines for Bioequivalence Study on Olanzapine Orally Disintegrating Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Calcium Acetate Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Entecavir Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Imatinib Mesylate Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Carbamazepine Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Leflunomide Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Rivaroxaban Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Sacubitril-Valsartan Tablets (Draft for Comments), Technical Guidelines for Bioequivalence Study on Fosrenol (Draft for Comments) and Technical Guidelines for Bioequivalence Study on Vildagliptin Tablets (Draft for Comments).
（6）Guidelines for the Correction of Covariates in Drug Clinical Trials (Draft for Comments) aims to elucidate the principles for the treatment of covariates in randomized controlled clinical trials and provide recommendations for trial design, statistical analysis and how to address important covariates in clinical trial. The guidelines are mainly applicable to the confirmatory clinical trials of drugs, which are also the valuable references for exploratory research.
（7）Technical Guidelines for research on Generic Drugs for Fulvestrant Injection (Draft for Comments), based on the characteristics of fulvestrant injection, proposes technical requirements for pharmaceutical research and non-clinical research in the development of generic drugs and defines the conditions under which generic drugs can be exempted from in vivo bioequivalence study.
