ICH GL 更新：从行业角度看 M4Q （R2） 的期望.pdf

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1、ICH GL Update:M4Q(R2)Expectations from an Industry Point of ViewHiroshi Ohtsuka(JPMA,Bayer Yakuhin Ltd.)1The views and opinions expressed in this presentation are those of the presenter and should not necessarily represent the views and opinions of the relevant organizations.Outline Missions of Phar

2、maceutical Industry Benefits of Revised M4Q Industry Expectations Considerations as industry2Missions of Pharmaceutical Industry3Five major missions of the pharmaceutical industry(by ChatGPT based AI):1.Research and Development(R&D):Innovating and developing new drugs and therapies to address unmet

3、medical needs and improve patient outcomes.2.Regulatory Compliance:Ensuring that all products meet safety,efficacy,and quality standards set by regulatory authorities to protect public health.3.Access to Medications:Working to improve access to essential medicines for patients globally,especially in

4、 underserved populations.4.Sustainability and Ethical Practices:Committing to ethical practices in drug manufacturing and distribution,as well as promoting environmental sustainability in operations.5.Patient Education and Support:Providing information and resources to help patients understand their

5、 medications and manage their health conditions effectively.Benefits of Revised M4Q to Regulators4Enhances benefit-risk considerationsIncreases access to quality data and informationStreamlines regulatory assessmentFacilitates oversight of pharmaceutical product qualityIncreases consistency and effi

6、ciency in regulatory decision-making and actionsImproves communication with industry and among regulatorsBenefits to regulators5Clarifies regulatory expectationsFacilitates applying the enhanced ICH quality strategy/visionStreamlines regulatory application preparationImproves the quality of submissi