Medical Policies Weekly

2. The Center for Drug Evaluation issued a number of drafts for comments

(1) "Technical Guidelines for Pharmaceutical Research and Evaluation of Human-derived Stem Cell Products (Draft for Comments)": The main content contains nine chapters, namely the introduction, scope of application, general principles, risk assessment and control, production materials, production process, quality research and quality standards, stability research, packaging and closed container systems. The first four chapters explain the drafting background of the guiding principles, the main applicable product types, the general principles followed, and the current main risks and risk control strategies of such products. The last five chapters cover each link of production and quality control of human-derived stem cell products, and under each chapter, the content that should be paid attention to in the pharmaceutical research and development of this kind of product is explained in detail.

(2) "Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-New Coronavirus Chemical Drugs (Trial)" (draft for comments): The guidelines are only applicable to chemical drugs intended to treat new coronavirus infections through direct antiviral action, the content mainly includes the antiviral mechanism of non-clinical pharmacodynamic research and evaluation of anti-coronavirus chemical drugs, the main points of in vitro antiviral tests, in vivo antiviral tests and other relevant considerations, and no specific test details are involved. Applicants can adopt reasonable research and development strategies and research methods according to the characteristics of the drug.

(3) " Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-New Coronavirus Pneumonia Inflammatory Drugs (Trial)" (draft for comments): The guidelines mainly include the general considerations of non-clinical pharmacodynamic research and evaluation of anti-coronavirus pneumonia inflammatory drugs, the main points of in vitro pharmacodynamics and in vivo pharmacodynamics. The guidelines are applicable to chemicals and biological products that have anti-inflammatory mechanisms and are intended to be used to treat the inflammation of new coronavirus pneumonia. There are currently no similar technical requirements and guidelines in foreign countries.

(4) "Technical Guidelines for Non-clinical Research on Anti-New Coronavirus Neutralizing Antibody Drugs (Trial)" (draft for comments): The guidelines are only applicable to new coronavirus neutralizing antibody drugs and are used to guide the non-clinical research of the new coronavirus neutralizing antibody under emergency conditions. The non-clinical research mainly includes the technical requirements of the test substance, pharmacological test, pharmacokinetic test and toxicological test and does not involve specific test details. Applicants can carry out relevant research work based on the characteristics of neutralizing antibodies and the specific conditions of their varieties.

(5) "Technical Guidelines for Clinical Trials of Generic Drugs of Oral Inhalation Formulations that are Listed Abroad and Domestically Unlisted (Draft for Public Comments)": On the basis of the "Clinical Technical Requirements for Overseas Marketed and Domestic Unmarketed Drugs" (No.29 of 2020) issued in October 2020, suggestions on the implementation conditions and design points of clinical trials with the purpose of "supporting the safety and effectiveness evaluation of generic drugs used in Chinese patients" for generic drugs of oral inhalation preparations.

(6) " Technical Guidelines for Pharmaceutical Research and Evaluation of Insulin Products (Draft for Comments)": The guidelines mainly include the scope of application, general principles, raw materials for production, production technology, quality research and quality standards, stability research and storage containers and the closed system, a total of seven aspects are explained. Among them, there are general requirements for the research and development of biosimilar drugs, as well as special technical considerations for insulin products, which generally clarify the risk points and technical requirements in the production process of such products.

(7) "Technical Guidelines for Clinical Trials of New Anti-rabies Monoclonal Antibody Drugs (Draft for Comments)": The guidelines set forth the main points of trial design and trial quality control considerations for the different clinical development stages of rabies monoclonal antibodies. Participant selection for clinical trials, control selection, endpoint indicators, usage and dosage, safety evaluation, etc. were emphatically explained.

(8) "Technical Guidelines for Clinical Trials of Drugs for Treatment of Arterial Pulmonary Hypertension (Draft for Comments)": The guidelines are divided into four chapters. The first chapter is the scope of application, which clarifies that this guideline is applicable to drug research and development of chemical drugs and therapeutic biological products. The second chapter is an overview, which mainly introduces the background content of the concept, disease characteristics, epidemiological data and treatment status of pulmonary hypertension. The third chapter is the overall consideration of clinical development, expounding from three aspects: clinical pharmacology research, exploratory clinical trial, and confirmatory clinical trial. The fourth chapter is the key elements of clinical trial design, from the study population, background treatment, control selection, dose selection, study period, effectiveness indicators and safety indicators, respectively, expounds the focus of each key element.

(9) "Technical Guidelines for Clinical Trials of Drugs for Treatment of Pediatric Arterial Pulmonary Hypertension (Draft for Comments)": The guidelines are divided into five chapters. The first chapter is the scope of application, which clarifies that the guidelines are applicable to the drug development of chemical drugs and therapeutic biological products, and the guidelines mainly focus on the special considerations for the development of pediatric arterial pulmonary hypertension (PAH) drugs. The second chapter is an overview, mainly introduces the background content of the disease specificity and the current status of treatment of pediatric pulmonary hypertension. The third chapter is the overall consideration of clinical development, which clarifies the consideration of the overall development strategy for the drugs used for adult PAH that benefit more than the risks and the drugs for which there is no safety and effectiveness data for adult PAH. The fourth chapter is pharmacodynamics and dose exploration research, which outlines the focus of pharmacodynamics and dose exploration research. The fifth chapter is the key elements of clinical trial design, from the study population, background treatment, control selection, dose selection, study period, effectiveness indicators and safety indicators, respectively, expounds the focus of each key element.

(10) "Guidelines for the Design of Clinical Trials of Drugs for the Prevention of Nausea and Vomiting Caused by Antitumor Drugs (Draft for Comments)": The guidelines first introduce the background of drafting the guidelines, then introduce the key issues that need to be paid attention to in the design of the plan from the three stages of drug clinical development (clinical pharmacology research, exploratory research and confirmatory research) , as well as some other issues that need to be considered, and explain the consideration points of the clinical trial design of drugs for the prevention of nausea and vomiting caused by antitumor drugs.

(11) "Guidelines for the Aggregation of Adverse Reaction Data in Anti-tumor Drug Instructions (Draft for Comments)": The guidelines first introduce the background of drafting the guidelines, then from the perspective of overall consideration, writing requirements, and other points to be paid attention to, explain the relevant content of whether the adverse reaction data of the anti-tumor drug label can be summarized, how to summarize, and how to be presented in the label.