【CODEX翻译】新型冠状病毒预防用疫苗研发技术指导原则（试行）-英文版

新型冠状病毒预防用疫苗研发技术指导原则（试行）

Technical Guidelines for the Research and Development of

the Preventive Vaccine against 2019 Novel Coronavirus (Trial)

一、前言

二、药学研究

（一）生产用菌（毒）种研究

（二）生产用细胞基质研究

（三）生产用主要原材料

（四）生产工艺研究

（五）质量研究

（六）质量标准研究

（七）临床试验申请用样品的制造检定记录

（八）初步稳定性试验

（九）直接接触制品的包装材料和容器的来源、选择依据及质量标准等研究

（十）外源因子安全性评价

（十一）临床期间的变更

三、非临床研究

（一）受试物

（二）药效学研究

（三）毒理研究

（四）药代动力学研究

（五）佐剂

四、临床研究

（一）临床试验设计

（二）风险与质量控制

五、参考指导原则

I. Introduction

II. Pharmaceutical Research

(I) Research on bacteria (virus) seeds used for production

(II) Research on cell matrix for production

(III) Main raw materials for production

(IV) Research on production process

(V) Quality research

(VI) Research on quality standards

(VII) Manufacturing Verification records of samples for clinical trial application

(VIII) Preliminary stability test

(IX) Research on the source, selection basis and quality standard of packaging materials and containers for direct contact products

(X) Safety evaluation of adventitious agents

(XI) Changes during the clinical period

III. Non-clinical Researches

(I) Test substance

(II) Pharmacodynamic Research

(III) Toxicological research

(IV) Pharmacokinetic research

(V) Adjuvant

IV. Clinical Research

(I) Clinical Trial Designs

(II) Risk and quality control

V. Reference Guidelines

一、前言

I. Introduction

      新型冠状病毒预防用疫苗（简称新冠疫苗）是预防和控制新型冠状病毒（简称新冠病毒）感染所致疾病（COVID-19）的创新型疫苗。为了积极应对COVID-19疫情，国内称新型冠状病毒肺炎（简称新冠肺炎）疫情，加快相关疫苗的研发，结合近期疫苗研发中出现的新问题、疫苗研发工作的新需要，特制定本技术指导原则。

The preventive vaccine against 2019 novel coronavirus (referred to as the 2019-nCoV vaccine) is an innovative vaccine to prevent and control the disease (COVID-19) caused by the 2019 Novel Coronavirus (referred to as novel coronavirus) infection. In order to actively respond to the COVID-19 epidemic and accelerate the research and development of related vaccines, the technical guidelines are formulated in light of the new problems in recent vaccine research and development and the new needs of vaccine research and development.

      目前，新冠疫苗的研发主要包括病毒灭活疫苗、基因工程重组疫苗、病毒载体类疫苗、核酸类疫苗（质粒DNA、mRNA等）等，申请人应根据各类疫苗的作用机制、递呈方式和诱导免疫应答的类型等核心要点，开展相关研究工作。如果有可替代或适用的其他研究，应提供相应说明以及支持性的理由和依据。

At present, the research and development of the 2019-nCoV vaccine mainly include inactivated vaccine, gene engineering recombinant vaccine, virus vector vaccine, nucleic acid vaccine (plasmid DNA, mRNA, etc.), etc. The applicant shall carry out relevant researches according to the key points such as the mechanism of action, mode of presentation and type of induced immune response of various vaccines. If there are other alternative or applicable researches, corresponding explanations and supporting reasons and basis shall be provided.

      鉴于生物医学新技术的迅速发展，同时也受限于对新冠病毒的生物学特性认知，本技术指导原则将随着研究的不断深入，以及相关研究数据的积累，不断进行完善和适时更新。

In view of the rapid development of new biomedical technology and limited by the recognition of biological characteristics of novel coronavirus, this technical guideline will be improved and updated in time with the deepening of research and the accumulation of relevant research data.

      在产品研发进程中，申请人可依据相关规定积极与审评机构进行沟通交流。

In the process of product development, the applicant can actively communicate with the evaluation institution in accordance with relevant regulations.

      本技术指导原则适用于灭活疫苗、基因工程重组疫苗、病毒载体类疫苗和DNA疫苗的研发，mRNA疫苗相关技术要求将另行制定。

The technical guideline is applicable to the research and development of inactivated vaccines, gene engineering recombinant vaccines, viral vector vaccines and DNA vaccines. The technical requirements for mRNA vaccines will be formulated separately.

      本技术指导原则是在满足注册法规基本原则的基础上，着重提出在新冠病毒疫情应急情况下的相关考量。具体品种（灭活疫苗、基因工程重组疫苗、病毒载体类疫苗、DNA疫苗）研发时可一并参考相关指导原则。

On the basis of meeting the basic principles of registration regulations, this technical guideline focuses on the relevant considerations in the emergency situation of COVID-19 epidemic. Specific varieties (inactivated vaccines, gene engineering recombinant vaccines, viral vector vaccines, DNA vaccines) can be developed with reference to relevant guidelines.

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