【CODEX翻译】药品上市许可持有人直接报告不良反应事宜-中英双语

Date：2022-02-15

￥414.60

【CODEX】国家药品监督管理局关于药品上市许可持有人直接报告

不良反应事宜的公告-中英双语

国家药品监督管理局关于药品上市许可持有人直接报告不良反应事宜的公告

Announcement of SDA on Direct Reporting of Adverse Reactions by Holders of Drug Marketing Authorization

根据《中华人民共和国药品管理法》、《中共中央办公厅、国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号），为进一步完善药品不良反应监测制度，落实药品上市许可持有人（包括持有药品批准文号的药品生产企业，以下简称持有人）不良反应报告主体责任，国家药品监督管理局就持有人直接报告不良反应公告如下：

According to the Pharmaceutical Administration Law of the People's Republic of China, Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices issued by General Office of the CPC Central Committee and General Office of the State Council (SC [2017] No. 42), State Drug Administration (SDA) made the following announcement on direct reporting of adverse reactions by holders of drug marketing authorization to further improve the monitoring system of adverse drug reactions and put into practice the principal responsibilities of the holders of drug marketing authorization (including drug manufacturers with drug approval documents, hereinafter referred to as the holders):

一、持有人应当建立健全药品不良反应监测体系。持有人是药品安全责任的主体，应当指定药品不良反应监测负责人，设立专门机构，配备专职人员，建立健全相关管理制度，直接报告药品不良反应，持续开展药品风险获益评估，采取有效的风险控制措施。

1. Holders shall establish and improve the monitoring system of adverse drug reactions. As the subjects undertaking drug safety responsibilities, holders shall designate personnel to be in charge of adverse drug reaction monitoring, set up specialized agencies, and equip full-time personnel, to establish and improve relevant management systems, directly report adverse drug reactions, and continue to carry out assessments for risks and benefits of drugs and adopt effective risk control measures.

持有人委托其他公司或者机构开展药品不良反应监测工作，双方应当签订委托协议。持有人应当配备专职人员做好对受托方的监督和管理等工作，相应法律责任由持有人承担。进口药品持有人应当指定在我国境内设立的代表机构或者指定我国境内企业法人作为代理人，具体承担进口药品不良反应监测、评价、风险控制等工作。持有人及其代理人应当接受药品监督管理部门的监督检查。

If holders entrust other companies or agencies to carry out the monitoring of adverse drug reactions, both parties shall sign an entrustment agreement. Holders shall designate full-time personnel to well finish the job of supervising and managing the entrusted parties, and the corresponding legal responsibilities shall be borne by holders. Holders of imported drug marketing authorization shall designate a representative agency established in China or designate an enterprise legal person in China as its agent to specifically undertake the monitoring, evaluation and risk control of adverse reactions of imported drugs. Holders and their agents shall be subject to supervision and inspection by drug regulatory authorities.

CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司，作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商，CODEX科译拥有更多的医学资深语言专家，能实现40多种语言对的互译，接受更高难度的医学领域的项目挑战，并在最短时间内适应以给出最合理的解决方案。保证最高质量，100%按时交付，高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX is a leading provider of cross-border communications based in Beijing. With our exclusive database in life science, and ISO 17100:2015 certified, CODEX has the required expertise and experience in localization, documentation, and medical literature to deliver a full range of end-to-end content and consulting services in many languages. We closely work with clients to deliver solutions to the challenges of engaging markets, consumers, and regulatory and patent environments worldwide.

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