盘点→最新国际医药政策合集[JUN-1 2022]

文摘 2022-06-15 13:45

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本篇摘要

以下整理分享最新发布的10项国际医药政策法规时事，包括：

FDA发布《结合人类基因组编辑的人类基因治疗产品》指南草案、生效版《当前药品生产质量管理规范和预防控制、外国供应商验证计划、故意掺假和生产安全法规：部分规定执行政策》指南、生效版《将老年人纳入癌症临床试验》指南、生效版《首次人体临床试验以扩展队列加速肿瘤药物和生物制剂的开发》指南、生效版《上市前进口请求PLAIR》指南、《药品供应链安全法案下的部分处方药验证系统》指南草案；EMA发布《EudraVigilance-EVWEB》用户手册1.6版、更新版《良好药物警戒实践GVP》指南；MHRA发布《合规监控流程》第1部分简介；瑞士药监Swissmedic发布更新版《唯一标识号CHRN（瑞士单一注册号）》指南。

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Unless we remember we cannot understand.

除非记住，否则就无法理解。

– E. M. Forster

FDA发布《结合人类基因组编辑的人类基因治疗产品》指南草案

Human Gene Therapy Products Incorporating Human Genome Editing

On 15 March 2022 the FDA published the draft guidance for industry.

In this guidance, we, FDA, are providing recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, this guidance provides recommendations regarding information that should be provided in an Investigational New Drug (IND) application in order to assess the safety and quality of the investigational GE product, as required in Title 21 of the Code of Federal Regulations 312.23 (21 CFR 312.23). This includes information on product design, product manufacturing, product testing, preclinical safety assessment, and clinical trial design.

https://www.fda.gov/media/156894/download

FDA发布生效版《当前药品生产质量管理规范和预防控制、外国供应商验证计划、故意掺假和生产安全法规：部分规定执行政策》指南

Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions

On 11 March 2022 the FDA published the final guidance for industry.

The purpose of this document is to state that the Food and Drug Administration (FDA, we, or the Agency), at this time and based on our current understanding of the risks, does not intend to enforce certain regulatory requirements as they currently apply to certain entities and/or activities. The applicable requirements are established in our regulations entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (21 CFR Part 507); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (21 CFR Part 117); “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (21 CFR Part 1, Subpart L (FSVP)); “Mitigation Strategies to Protect Food Against Intentional Adulteration” (21 CFR Part 121); and “Standards for Growing, Harvesting, Packing, or Holding of Produce for Human Consumption” (21 CFR Part 112).

https://www.fda.gov/media/156729/download

FDA发布生效版《将老年人纳入癌症临床试验》指南

Inclusion of Older Adults in Cancer Clinical Trials

On 2 March 2022 the FDA published the final guidance for industry.

This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this final guidance, older adults are those age 65 years and older. The final guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials. Specifically, this final guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population.

https://www.fda.gov/media/156616/download

FDA发布生效版《首次人体临床试验以扩展队列加速肿瘤药物和生物制剂的开发》指南

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

On 1 March 2022 the FDA published the final guidance for industry.

The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs. These are trial designs that employ multiple, concurrently accruing subject cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and antitumor activity of the drug product.

https://www.fda.gov/media/115172/download

FDA发布生效版《上市前进口请求PLAIR》指南

Pre-Launch Activities Importation Requests (PLAIR)

On 1 March 2022 the FDA published the final guidance on the PLAIR for industry.

This guidance finalizes and updates the draft guidance of the same title issued on July 24, 2013. This guidance finalizes FDA's approach for overseeing requests regarding the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This guidance further describes the procedures for making these requests and FDA's actions on such requests. Finalizing this policy will help increase efficiencies in ensuring timely access to drug products upon approval.

https://www.fda.gov/media/86243/download

FDA发布《药品供应链安全法案下的部分处方药验证系统》指南草案

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

On 9 March 2022 the FDA published the draft guidance for industry.

This revised draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. It also addresses the requirement for notification to the FDA of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, this draft guidance addresses the requirement for responding to requests for verification and processing saleable returns.

https://www.fda.gov/media/117950/download

EMA发布《EudraVigilance-EVWEB》用户手册1.6版

EudraVigilance - EVWEB User Manual

On 15 March 2022 the EMA announced the availability of the updated EudraVigilance Web reporting tool EVWEB user manual, version 1.6 corr.

This user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool EVWEB.

The user manual consists of 5 chapters.

Chapter 1 presents a comprehensive overview of the EVWEB application and should be read before the other chapters. It contains basic information regarding the structure, functions and use of EVWEB, which applies to all other sections and needs to be understood before moving on to the more advanced aspects of the system.

Chapter 2 describes the creation and transmission of Safety and Acknowledgement messages, as well as the functions available in the WEB Trader, ICSRs, Post and Workspace screens.

Chapter 3 explains the integration of MedDRA in EVWEB and how to query the system for specific MedDRA terms.

Chapter 4 provides an insight into the administration tools available in EVWEB.

Chapter 5 lists the abbreviations and acronyms, along with their descriptions, introduced in this user manual.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-evweb-user-manual-version-16-corr_en.pdf

EMA发布更新版《良好药物警戒实践GVP》指南

Update Guidelines on Good Pharmacovigilance Practices (GVP)

On 14 March 2022 the EMA updated the GVP guideline on introductory cover note, last updated with release of Addendum III of Module XVI on pregnancy prevention programmes for public consultation.

This guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.

Today, a public consultation is launched for Addendum III of Module XVI on pregnancy prevention programmes and other pregnancy-specific risk minimisation measures. This new guidance defines the elements of a pregnancy prevention programme and provides for deciding when such programme is needed or other risk minimisation measures are considered appropriate to avoid adverse pregnancy outcomes due to use of medicines and to preserve health of both the mother and the child.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-release_en.pdf

MHRA发布《合规监控流程》第1部分简介

Compliance Monitor process (Part 1) – An introduction

On 11 March 2022 the MHRA Inspectorate Blog published the introduction part on the compliance monitor process.

From April 2022, the MHRA will begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM). The CM will work with the company to deliver actions identified in a Compliance Protocol (CP), that has been agreed with the MHRA. High-level updates on progress against the CP will be communicated to the MHRA at a pre-agreed frequency (provision of additional detail will be by exception against the CP requirements).

https://mhrainspectorate.blog.gov.uk/2022/03/11/compliance-monitor-process-part-1-an-introduction/

瑞士药监Swissmedic发布更新版《唯一标识号CHRN（瑞士单一注册号）》指南

Unique identification number (CHRN – Swiss Single Registration Number)

On 3 March 2022 the Swissmedic updated the guidance on the unique Swiss Single Registration Number for medical devices.

The Swiss Single Registration Number (CHRN) is a unique identification number that Swissmedic assigns to Swiss manufacturers, authorised representatives and importers upon request. The CHRN is used to unambiguously identify a manufacturer, authorised representative or importer.

Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland. To mitigate the consequences of this loss of information and to continue to ensure market surveillance in Switzerland, it is necessary for manufacturers, authorised representatives and importers domiciled in Switzerland to register once with Swissmedic.

https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html

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