盘点→最新国际医药政策合集[JUN-2 2022]

文摘健康医疗 2022-07-04 13:00 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发布生效版《NDA或IND中提交的生物利用度研究的一般考虑》指南、生效版《开发治疗慢性乙型肝炎病毒药物》指南、《ICH M7（R2）附录：计算化合物特定可接受摄入量》指南草案、《旨在提高临床试验中代表性不足的种族和族裔人群的参与者登记率多样性计划》指南草案、生效版《人类血液和血液成分使用的可接受信息》指南、生效版《关于特定眼科产品遵守21 CFR第4部分政策》指南；EMA发布更新版《集中批准后的程序更新建议》、更新版《EMA EudraVigilance注册手册》、《ICH指南E14/S7B：QT/QTc间期延长和致心律失常电位的临床和非临床评估–问与答–第5阶段》指南、生效版《需要考虑乌克兰战争对正在进行的临床试验方法学方面的影响的要点》指南、更新版《IRIS申请人指南》。

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Growth is the only evidence of life.

成长是生命存在的唯一证明。

– John Henry Newman

FDA发布生效版《NDA或IND中提交的生物利用度研究的一般考虑》指南

Bioavailability Studies Submitted in NDAs or INDs – General Considerations

On 14 April 2022 the FDA published the final guidance on general considerations for bioavailability studies submitted in NDAs or INDs.

This guidance provides recommendations to sponsors and applicants submitting bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This guidance contains recommendations on how to meet the BA requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration. These dosage forms include tablets, capsules, solutions, suspensions, conventional (e.g., immediate-release (IR) drug products) and modified-release (MR) (e.g., extended-release (ER), delayed-release (DR)) drug products. The guidance is also applicable to non-orally administered drug products when it is appropriate to rely on systemic exposure measures to determine the BA of a drug (e.g., transdermal delivery systems and certain vaginal, rectal, and nasal drug products). The guidance provides recommendations on conducting BA studies during the investigational period for a drug intended to be submitted for approval in an NDA and bioequivalence (BE) studies during the postapproval period for certain changes to drug products with an approved NDA.

https://www.fda.gov/media/121311/download

FDA发布生效版《开发治疗慢性乙型肝炎病毒药物》指南

Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment

On 6 April 2022 the FDA published the final guidance on developing drugs for chronic hepatitis B virus infection.

The purpose of this guidance is to assist sponsors in the clinical development of drugs and biologics for the treatment of chronic hepatitis B virus (HBV) infection from the initial investigational new drug application (IND) through the new drug application (NDA)/biologics license application (BLA) and postmarketing phases.

https://www.fda.gov/media/117977/download

FDA发布《ICH M7（R2）附录：计算化合物特定可接受摄入量》指南草案

M7(R2) Addendum: Application of The Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes

On 6 April 2022 the FDA published draft guidance on ICH M7 addendum for industry.

The ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory expectations in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized safety reporting and marketing application submissions, and contributed to many other improvements in the quality of global drug development and manufacturing and the products available to patients.

https://www.fda.gov/media/157451/download

FDA发布《旨在提高临床试验中代表性不足的种族和族裔人群的参与者登记率多样性计划》指南草案

Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials

On 13 April 2022 the FDA announced the availability of the draft guidance for industry.

The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States.

https://www.fda.gov/media/157635/download

FDA发布生效版《人类血液和血液成分使用的可接受信息》指南

An Acceptable Circular of Information for the Use of Human Blood and Blood Components

On 22 March 2022 the FDA published final guidance for industry.

FDA, Center for Biologics Evaluation and Research, are recognizing as acceptable for use by manufacturers of blood and blood components intended for transfusion, the document entitled “Circular of Information for the Use of Human Blood and Blood Components,” dated December 2021 (December 2021 Circular). The December 2021 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the December 2021 Circular will assist you in complying with labeling requirements under 21 CFR 606.122. The requirements under 21 CFR 606.122 specify that a circular of information must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the circular of information. This guidance supersedes the guidance of the same title updated December 2017.

https://www.fda.gov/media/86898/download

FDA发布生效版《关于特定眼科产品遵守21 CFR第4部分政策》指南

Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4

On 22 March 2022 the FDA published final guidance for industry.

This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements in part 4 (21 CFR part 4) for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. This guidance applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) without an approved application under section 505 of the FD&C Act (21 U.S.C. 355) (commonly referred to as over-the-counter (OTC) monograph drugs).

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

EMA发布更新版《集中批准后的程序更新建议》

Updated EMA Post-authorisation Procedural Advice for Users of the Centralised Procedure

On 18 March 2022 the EMA updated the EudraVigilance registration manual.

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf

EMA发布更新版《EMA EudraVigilance注册手册》

Updated EMA EudraVigilance Registration Manual

On 17 March 2022 the EMA updated the EudraVigilance registration manual.

To set-up a new organisation in EudraVigilance Production or XCOMP (Test system), a series of steps need to be followed. Once the QPPV or RP is registered for the Production EudraVigilance system they will automatically also be registered for an XCOMP test account for the same organisation.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-registration-manual_en.pdf

EMA发布《ICH指南E14/S7B：QT/QTc间期延长和致心律失常电位的临床和非临床评估–问与答–第5阶段》指南

ICH guideline E14/S7B: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential – Q&A – Step 5

On 24 March 2022 the EMA published the ICH Q&A guideline E14/S7B.

This Q&A guideline concerns the clinical evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products. It addresses the electrocardiograms methodology, gender, positive control, study design, use of concentration response modeling of QTc data and electrocardiogram monitoring in late stage clinical trials.

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e14/s7b-clinical-nonclinical-evaluation-qt/qtc-interval-prolongation-proarrhythmic-potential-questions-answers-step-5_en.pdf

EMA发布生效版《需要考虑乌克兰战争对正在进行的临床试验方法学方面的影响的要点》指南

Points to Consider on the Impact of the War in Ukraine on Methodological Aspects of Ongoing Clinical Trials

On 13 April 2022 the EMA published the guidance on the actions for ongoing clinical trials affected by the war in Ukraine.

This guidance covers actions that sponsors of ongoing clinical trials affected by the war in Ukraine can take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority.

EMA strongly encourages sponsors to capture data affected and unaffected by the war, and to use the 'estimand framework' described in the ICH E9 (R1) guideline for dealing with events impacting the trial.

https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-impact-war-ukraine-methodological-aspects-ongoing-clinical-trials_en.pdf

EMA发布更新版《IRIS申请人指南》

Updated IRIS Guide for Applicants

On 13 April 2022 the EMA published the updated IRIS guide on how to create and submit scientific applications, for industry and individual applicants, version 2.8.

This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, marketing status reports, inspections and veterinary signal management) and related activities.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdf

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