|
英国药监MHRA发布更新版临床试验一期中心清单、欧盟EMA对英国脱欧的最新工作状态、欧盟EMA启用在荷兰阿姆斯特丹的新办公楼、欧盟EMA开展无菌药品GMP国际联合检查试点项目、欧盟EMA发布回顾四年的药物警戒工作报告、美国FDA发布《药物-器械联用产品》的指南草案、美国FDA发布《证明药物和生物制品有效性的实质证据》指南草案。 阅读原文请复制文后链接并在浏览器新开页面
What we do every day matters more than what we do once in a while.MHRA Phase I Accreditation Scheme On 20 December 2019 the MHRA updated the List of Accredited Phase I Units.The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, in particular for those conducting first in human (FIH) trials.The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials.Organisations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.https://assets.publishing./government/uploads/system/uploads/attachment_data/file/854619/List_of_accredited_units__20_Dec_2019_.pdfBrexit Update: The United Kingdom's Withdrawal From The European Union On 20 December 2019 the EMA updated the UK withdrawal from the EU.On 29 October 2019, the European Council agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 January 2020. In defining its work program for 2020 and beyond, EMA will focus on the core activities identified in phase four of its business continuity plan as a baseline. It will prioritize additional tasks depending on available resources.The Agency is still in the process of rebuilding its workforce after its relocation. It will continue to monitor staff levels and review whether it can relaunch additional activities in June 2020.As of December 2019, EMA's total available workforce was 775. This is significantly less than in November 2017 when EMA’s relocation plans took shape. https://www.ema./en/about-us/brexit-united-kingdoms-withdrawal-european-unionEMA New building in Amsterdam Orientation Guide for IndustryOn 19 December 2019 the EMA updated the orientation guide for industry to its new building in Amsterdam.https://www.ema./en/documents/other/orientation-guide-industry-ema-building_en.pdfLaunch of International Pilot Programme on Inspection of Manufacturers of Sterile Medicines On 17 December 2019 the EMA updated the international collaboration on GMP inspections.In December 2019, EMA and its European and international partners launched a pilot programme to share information on GMP inspections of manufacturers of sterile medicines located outside the participating countries and to organise joint inspections of manufacturing sites of common interest.The products in scope include sterile medicines for human use of chemical origin and certain therapeutic biotechnology-derived products, such as monoclonal antibodies and recombinant proteins.Vaccines, cell and gene therapies and plasma-derived pharmaceuticals are currently out of the scope of this pilot.https://www.ema./en/documents/other/pilot-programme-international-cooperation-gmp-inspection-manufacturers-sterile-medicinal-products_en.pdf4-Year Overview of Pharmacovigilance Activities in the EU Shows Robust and Effective Medicines Safety SystemOn 17 December 2019 the EMA released the report on the impact of pharmacovigilance measures covering the period 01 January 2015 to 31 December 2018.A report on the activities ensuring the safety of medicines carried out by EMA and the national competent authorities of the European Union (EU) Member States, Norway and Iceland from 2015 to 2018 shows that the EU pharmacovigilance system is strong and adaptable and has had a positive impact on public health. The report measures the longer-term impact of the pharmacovigilance legislation, which came into effect in July 2012, in terms of simplification of pharmacovigilance processes, improved transparency and stakeholder engagement and protection of patient health. The measurement of impact is based on a strategy and action plan for measuring the impact of pharmacovigilance activities, adopted by EMA’s safety committee (PRAC) in 2017. https://www.ema./en/documents/press-release/4-year-overview-pharmacovigilance-activities-eu-shows-robust-effective-medicines-safety-system_en.pdfFDA Guidance on Bridging for Drug-Device and Biologic-Device Combination ProductsOn 18 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 18 February 2020.This guidance provides recommendations to industry and FDA staff on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or copackaged combination products. It will help to fulfill the performance goals under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). For the purposes of this guidance, the term bridging refers to the process of establishing the scientific relevance of information developed in an earlier phase of the development program or another development program to support the combination product for which an applicant is seeking approval. Once the applicant has established the relevance of such information to (i.e., bridged to) its product, the applicant may be able to leverage that information to streamline the development program. https://www./media/133676/download美国FDA发布《证明药物和生物制品有效性的实质证据》指南草案
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products On 20 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 21 February 2020.This document is intended to provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness. This guidance complements and expands on the 1998 guidance entitled Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (the 1998 guidance). https://www./media/133660/download
|
