盘点→最新国际医药政策合集[May-1 2022]

文摘健康医疗 2022-05-27 12:50 上海

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本篇摘要

以下整理分享最新发布的9项国际医药政策法规时事，包括：

FDA发布最终版《以患者为中心的药物开发》指南、最终版《加速肿瘤药物和生物制剂开发的有效临床试验设计主方案策略》指南、最终版《CAR-T细胞产品的开发考量》指南草案；EC发布《Eudralex第4卷-欧盟人用和兽用医药产品良好生产规范指南附录21：进口医药产品》指南；EMA发布《首次上市授权申请的评估时间延长最长90天》程序、《申办者寻求科学建议和方案支持》指南、更新版《EudraVigilance EVWEB》用户手册、更新版《临床药理学和药代动力学》问与答指南、更新版《良好临床实践GCP》问与答指南。

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FDA发布最终版《以患者为中心的药物开发》指南

Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

On 25 February 2022 the FDA published the final guidance for industry, FDA staff and other stakeholders.

This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development (PFDD) guidance documents that FDA is developing to describe in a stepwise manner how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.

https://www.fda.gov/media/131230/download

FDA发布最终版《加速肿瘤药物和生物制剂开发的有效临床试验设计主方案策略》指南

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

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

This guidance provides recommendations to sponsors of drugs or biologics for the treatment of cancer regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In general, the recommended phase 2 dose (RP2D) should have been established for an investigational drug or drugs evaluated in a master protocol.

https://www.fda.gov/media/120721/download

FDA发布最终版《CAR-T细胞产品的开发考量》指南草案

Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products

On 15 March 2022 the FDA published the draft guidance for industry.

Chimeric antigen receptor (CAR) T cell products are human gene therapy products in which the T cell specificity is genetically modified to enable recognition of a desired target antigen for therapeutic purposes. This guidance is intended to assist sponsors, including industry and academic sponsors, developing CAR T cell products. In this guidance, we, FDA, provide CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.

https://www.fda.gov/media/156896/download

EC发布《Eudralex第4卷-欧盟人用和兽用医药产品良好生产规范指南附录21：进口医药产品》指南

Eudralex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 21: Importation of Medicinal Products

On 21 February 2022 the European Commission published the Annex 21 of Eudralex Volume 4 EU guideline for GMP.

This Annex summarizes the GMP requirements applicable to a Manufacturing Import Authorisation (MIA) holder, when importing medicinal products (human, investigational and veterinary) from outside the EU/EEA. The guidance in the main chapters and other annexes of the Guide to Good Manufacturing Practice for Medicinal Products ("the EU GMP Guide") also apply, as appropriate, for other GMP activities carried out and should be consulted for supplementary guidance. Medicinal products that enter the EU/EEA with the intention of export only and that are not processed in any form nor released for placing on the EU/EEA market, are not covered by this Annex.

https://ec.europa.eu/health/latest-updates/eudralex-volume-4-eu-guidelines-good-manufacturing-practice-medicinal-products-human-and-veterinary-2022-02-21_en

EMA发布《首次上市授权申请的评估时间延长最长90天》程序

Procedural Advice – Extended Assessment Time for Initial Marketing Authorisation Applications of 90 Days

On 25 February 2022 the EMA published the extended assessment time for initial marketing authorisation applications.

For the majority of scientific evaluations of centralised marketing authorisation applications, the rapporteurs and their supporting assessment teams will have in-depth scientific knowledge and experience in the relevant scientific areas. However, in order to provide the highest level of relevant expertise, it is occasionally necessary to seek expertise from outside the allocated assessment teams, which can be a time consuming process, in particular if such a request occurs ad-hoc. In order to facilitate the assessment by the CVMP in such cases, Regulation (EU) 2019/6 has introduced a provision to exceptionally extend the standard timeframe for an initial assessment procedure by a maximum of 90 days in cases where particular expertise is required.

This document outlines the criteria for such “particular expertise”, as well as the procedural steps to take into account when deciding on the use of such additional time.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-extended-assessment-time-initial-marketing-authorisation-applications-90-days_en.pdf

EMA发布《申办者寻求科学建议和方案支持》指南

European Medicines Agency Guidance for Applicants Seeking Scientific Advice and Protocol Assistance

On 24 February 2022 the EMA published the updated guidance for scientific advice or protocol assistance procedures.

This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific advice or protocol assistance and gives guidance to Applicants in preparing their request. This guidance document also explains the scope and nature of scientific advice and protocol assistance. It will enable Applicants to submit requests which are in line with Scientific Advice Working Party (SAWP) requirements and which can be validated and evaluated quickly and efficiently.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-guidance-applicants-seeking-scientific-advice-protocol-assistance_en.pdf

EMA发布更新版《EudraVigilance EVWEB》用户手册

Updated EudraVigilance - EVWEB User Manual

On 23 February 2022 the EMA published the updated user manual (version 1.6) for EdraVigilance web reporting tool EVWEB.

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_en.pdf

EMA发布更新版《临床药理学和药代动力学》问与答指南

Updated Clinical Pharmacology and Pharmacokinetics: Questions and Answers

On 16 February 2022 the EMA published the updated Q&A guidance on expectations for bootstrapping to calculate the 90% confidence interval for the f2 similarity factor.

This Q&A section 3.11 describes expectations for conducting and reporting bootstrap methodology. The use of two-sided 90% confidence interval of f2 is the recommended methodology for dissolution comparison when highly variable conditions occur, since the use of f2 could be highly influenced by the experimental dissolution data and might not represent the population (true) f2.

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/clinical-pharmacology-pharmacokinetics-questions-answers

EMA发布更新版《良好临床实践GCP》问与答指南

Updated Q&A: Good Clinical Practice (GCP)

On 15 March 2022 the EMA updated the Q&A guidance on the GCP.

EMA has updated the following Q&A on the GCP:

-IMPs in bioavailability and bioequivalence: Q3

-GCP matters: Q1-3, 8, 11, 14, 15

-Records of study subject data relating to clinical trials: Q2

https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice/qa-good-clinical-practice-gcp

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