盘点→最新国际医药政策合集[JUL-1 2022]

文摘健康医疗 2022-07-26 10:45 上海

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本篇摘要

以下整理分享最新发布的11项国际医药政策法规时事，包括：

FDA发布《产品质量评估的获益-风险考虑》指南草案、《人体放射性标记物平衡研究的临床药理学考虑》指南草案、《ctDNA在早期实体瘤药物开发中的应用》指南草案、生效版《以电子格式提交上市后安全报告材料》指南、生效版《含有纳米材料的药品及生物制品》指南；EMA发布《涉及MAH 的GMP和GCP检查》指南草案、《在临床试验信息系统CTIS上传和发布的文件中保护个人数据和商业机密信息》指南草案、更新版《药物警戒风险评估委员会评估药物警戒活动的影响的策略》指南、《ICH元素杂质指南Q3D（R2）》指南第5阶段、更新版《良好临床实践GCP检查程序》指南；MHRA发布《合规监控流程-合规监控的角色和应用流程》流程第2部分。

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We are drowning in information but starved for knowledge.

我们被信息淹没，却渴望知识。

– John Naisbitt

FDA发布《产品质量评估的获益-风险考虑》指南草案

Benefit-Risk Considerations for Product Quality Assessments

On 10 May 2022 the FDA published the draft guidance for industry.

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA assessment as part of original new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), original biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act), or supplements to such applications, in addition to other information (e.g., inspectional findings) available to FDA during its assessment.

https://www.fda.gov/media/158204/download

FDA发布《人体放射性标记物平衡研究的临床药理学考虑》指南草案

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

On 5 May 2022 the FDA published the draft guidance for industry. Comments may be submitted by 4 August 2022.

This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs, including: (1) deciding whether and when to conduct the study, (2) designing the study, and (3) reporting results. This guidance does not cover animal mass balance studies, safety testing of drug metabolites, or recommendations for selecting the radioactive dose.

https://www.fda.gov/media/158178/download

FDA发布《ctDNA在早期实体瘤药物开发中的应用》指南草案

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development

On 2 May 2022 the FDA announced the availability of the draft guidance for industry.

This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage setting.

https://www.fda.gov/media/158072/download

FDA发布生效版《以电子格式提交上市后安全报告材料》指南

Providing Submissions in Electronic Format — Postmarketing Safety Reports

On 27 April 2022 the FDA published the final guidance on electronic submissions of postmarketing safety reports for industry.

This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance provides general information on the electronic submission of postmarketing safety reports under the following provisions:

• 21 CFR 314.80 and 314.98 (regarding products with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), respectively, including combination products or drug constituent parts with approved NDAs or ANDAs

• 21 CFR 600.80 (regarding products with approved biologics license applications (BLAs), including combination products or biological product constituent parts with approved BLAs)

• 21 CFR part 4, subpart B (requiring additional reports for combination products with approved NDAs, ANDAs, or BLAs)

• 21 CFR 310.305 (regarding prescription drug products marketed for human use without approved NDAs or ANDAs, including prescription drug products that are compounded by facilities registered as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b))

• 21 CFR 329.100 and section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379aa) (regarding nonprescription drug products marketed for human use without approved NDAs or ANDAs)

https://www.fda.gov/media/71176/download

FDA发布生效版《含有纳米材料的药品及生物制品》指南

Drug Products, Including Biological Products, that Contain Nanomaterials

On 21 April 2022 the FDA published the final guidance on drug products with nanomaterials for industry.

Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products. Nanotechnology may be used to create drug products in which nanomaterials (as explained in section II of this document), serve a variety of functions, as active ingredients or inactive ingredients, including carriers loaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form.

https://www.fda.gov/media/157812/download

EMA发布《涉及MAH的GMP和GCP检查》指南草案

Guidance for Applicants/MAHs Involved in GMP and GCP Inspections Coordinated by EMA

On 2 April 2022 the EMA published the guidance for applicants/MAHs involved in GMP and GCP inspections.

These GMP and GCP inspections are requested by the Committee for Medicinal Products for Human Use (CHMP) in order to verify compliance with Good Manufacturing Practice of sites responsible for the manufacture of centrally authorised products and to verify compliance with with Good Clinical Practice for centrally authorised products.

The details of each of the inspections adopted by the Committee(s), including the contact details of the persons in the inspection services who will be involved can be found in the IRIS Industry portal.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants/mahs-involved-gmp-gcp-inspections-coordinated-ema_en.pdf

EMA发布《在临床试验信息系统CTIS上传和发布的文件中保护个人数据和商业机密信息》指南草案

Draft Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the Clinical Trial Information System (CTIS)

On 8 April 2022 the EMA published the draft guidance on protection of personal data and commercially confidential information in CTIS.

This guidance document focuses on the following areas:

• Description of the CTIS structure and components including a description of the functionalities and publication rules for clinical trials information submitted to the CTIS (chapter 2)

• The protection of personal data as part of the clinical trial information submitted to CTIS (chapter 3)

• The protection of commercially confidential information (CCI) as part of the clinical trial information submitted to CTIS (chapter 4)

• The protection of personal data and CCI in inspection reports (chapter 5)

https://www.ema.europa.eu/en/documents/other/draft-guidance-document-how-approach-protection-personal-data-commercially-confidential-information_en.pdf

EMA发布更新版《药物警戒风险评估委员会评估药物警戒活动的影响的策略》指南

Updated Pharmacovigilance: PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities

On 21 April 2022 the EMA updated PV guidance on Pharmacovigilance Risk Assessment Committee (PRAC), revision 2.

The strategy aims to shift the focus of pharmacovigilance towards the activities and regulatory tools that are most relevant to patients and make the greatest difference in daily healthcare.

The latest revision highlights the achievements attained since the strategy's launch, in its four key activity areas:

• effectiveness evaluation of risk-minimization measures;

• effectiveness of pharmacovigilance processes;

• enablers of effective pharmacovigilance and stakeholder engagement;

• analytical methods for impact research.

The revised strategy also includes:

• new information on how to prioritize and carry out impact research;

• a review of industry-sponsored post-authorization safety studies evaluating the effectiveness of risk-minimization measures.

https://www.ema.europa.eu/en/documents/other/prac-strategy-measuring-impact-pharmacovigilance-activities_en.pdf

EMA发布《ICH元素杂质指南Q3D（R2）》指南第5阶段

ICH Guideline Q3D (R2) on Elemental Impurities

On 3 May 2022 the EMA published the revised ICH guideline Q3D (R2) on elemental impurities, step 5.

This guideline presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in ICH Q9. This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.

https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-16.pdf

EMA发布更新版《良好临床实践GCP检查程序》指南

Updated Good Clinical Practice (GCP) Inspection Procedures

On 5 May 2022 the EMA announced the updates of the guidance on GCP inspection procedures.

The updated GCP inspection procedures include the Annexes I, II, IV, VI, VII: To Procedure for Conducting GCP Inspections Requested by the CHMP: Investigator Site; Clinical Laboratories; Sponsor and CRO; Record Keeping and Archiving of Documents; Bioanalytical Part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials, respectively.

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

MHRA发布《合规监控流程-合规监控的角色和应用流程》流程第2部分

Compliance Monitor Process (Part 2)– CM Role and Application Process

On 10 May 2022 the UK MHRA Inspectorate published the second part of the compliance monitor process.

As outlined in the first part of this blog, the MHRA is starting a pilot in April 2022 whereby Compliance Monitors (CM) will supervise the completion of an agreed Compliance Protocol (CP) for eligible Inspection Action Group (IAG) cases. It is common for companies that are at IAG to employ consultants to assist with remediation activities. The pilot for the compliance monitor process will establish a framework for the CM to carry out the remediation work but also report on progress to the MHRA. This second blog provides details on the CM role and application process.

https://mhrainspectorate.blog.gov.uk/2022/05/10/compliance-monitor-process-part-2-cm-role-and-application-process/

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