以下整理分享最新发布的18项国际医药政策法规时事,包括:
FDA发布《以患者为中心的药物开发:选择、开发或修改适合目的的临床结果评估》指南草案、《Q9(R1)质量风险管理》指南草案、《开发膀胱癌的辅助治疗药物和生物制剂》指南、《开发肾细胞癌的辅助治疗药物和生物制剂》指南、《开发寡核苷酸治疗药物的临床药理学考虑》指南草案、《在IND和NDA中评估食物对药物的影响-临床药理学考虑》指南、《再生医学疗法自愿共识标准认可计划》指南草案、《放射设备上市前提交的定量成像技术性能评估》指南;EMA发布《药品数据质量框架监管研讨会报告》、《强制使用ISO/ICH E2B(R3)ICSR安全报告:使用EudraVigilance系统》实践培训课程、《对集中程序用户的上市批准前程序建议》指南、《对集中程序用户的上市批准后程序建议》指南、《更改申办者的名称或地址》、《罕病药:监管和程序指南及表格》、《EudraVigilance用户界面安装》指南、《eXtended EudraVigilance药品字典(XEVMPD)数据输入工具(EVWEB)》用户手册;EC发布《复杂临床试验问与答》指南;MHRA发布《提交150天上市申请(MAA)的英国和欧盟委员会决策程序》指南。
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Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
On 29 June 2022 the FDA published the draft guidance on the patient-focused drug development.
Q9(R1) Quality Risk Management
On 14 June 2022 the FDA issued the draft guidance on quality risk management.
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment
On 27 June 2022 the FDA published the final guidance on the adjuvant treatment of bladder cancer for industry.
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
On 27 June 2022 the FDA published the final guidance on the adjuvant treatment of renal cell carcinoma for industry.
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
On 27 June 2022 the FDA published the draft guidance for industry.
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
On 24 June 2022 the FDA published the final guidance on food-effect on drug in INDs and NDAs.
This guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products under investigational new drug applications (INDs) to support new drug applications (NDAs) and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). This guidance revises and replaces part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002).
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
On 15 June 2022 the FDA published the draft guidance for industry.
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
On 16 June 2022 the FDA published the final guidance on a premarket submission for radiological devices for industry and FDA staff.
Report of Workshop on Data Quality Framework for Medicines Regulation
On 29 June 2022 the EMA published the report of the workshop on data quality framework for medicines regulation.
The workshop was an initiative of HMA, EMA and TEHDAS meant to both share the current progress on building a data quality framework for medicines regulation and to solicit the comments and ideas of experts in this field to help shape the drafting process. Breakout sessions focused on particular use cases with fruitful discussions on the current data quality landscape and how the future of data quality in medicines regulation should look in the clinical and non-clinical areas.
https://www.ema.europa.eu/en/documents/report/report-data-quality-framework-medicines-regulation_en.pdf
Mandatory Use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course on Using the EudraVigilance System
On 15 June 2022 the EMA announced the online training course on using the EudraVigilance system.
This training course covers the use of the ISO ICSR/ICH E2B(R3) format and related ISO standard terminology for pharmaceutical form and route of administration for reporting individual cases of suspected side effects to EudraVigilance.
https://www.ema.europa.eu/en/events/mandatory-use-iso-ich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-22
European Medicines Agency Pre-authorisation Procedural Advice for Users of the Centralised Procedure
On 20 June 2022 the EMA published the updated pre-authorisation Q&A guidance.
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf
European Medicines Agency Post-authorisation Procedural Advice for Users of the Centralised Procedure
On 20 June 2022 the EMA published the updated Q&A guidance on extensions of marketing authorisations.
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
Changing the Name or Address of a Sponsor
On 9 June 2022 the EMA announced the update for submitting a request to change the name or address.
Sponsors need to use EMA's IRIS platform to request changes to their name or address. The EMA is not able to process any requests outside of IRIS.
https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/changing-name-address-sponsor
Orphans: Regulatory and Procedural Guidance and Forms
On 9 June 2022 the EMA announced the updates for the regulatory and procedural guidance documents on orphan designation.
https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/applying-designation/orphans-regulatory-procedural-guidance-forms
Article 57 User Interface (UI) Installation Guide
On 7 June 2022 the EMA published the updated the installation guide on article 57 UI components and initial set up.
This document provides detailed steps to follow to install Article 57 components on users' computers to support the use of the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) data-entry tool user interface known as EVWEB.
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/article-57-user-interface-ui-installation-guide-installation-article-57-ui-components-initial-set_en.pdf
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual
On 7 June 2022 the EMA published the updated EVWEB user manual, version 5.7.
https://www.ema.europa.eu/en/documents/other/extended-eudravigilance-medicinal-product-dictionary-xevmpd-data-entry-tool-evweb-user-manual_en.pdf
Questions and answers - Complex clinical trials
On 2 June 2022 the European Commission published the updated Q&A guidance on complex clinical trials, version 2022-05-23.
This Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT authorisation (CTA), conduct, reporting and transparency, analysis and interpretation of complex clinical trials (CCTs) under the EU Clinical Trials Regulation (EU CTR) as well as their use in submissions for marketing authorisation.
https://health.ec.europa.eu/latest-updates/questions-and-answers-complex-clinical-trials-2022-06-02_en
Marketing Authorisation Application (MAA) Submission Dates for 150-days National and European Commission Decision Reliance Procedures
On 20 June 2022 the MHRA published the updated guidance on MAA submission dates.
The MHRA will operate a 150-day Assessment route for high-quality marketing authorisation applications (MAAs). Submission deadlines were updated.
https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures#full-publication-update-history
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