Regulatory Updates – June 2020

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CDSCO: Amendment in export policy for Paracetamol

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Philippines FDA: Interim guidelines for the importation and manufacture of personal protective equipment (PPE), ventilators and respirators to be used in the Covid-19 pandemic

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FDA: Upcoming product-specific guidance’s for complex generic drug product development

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ICH: ICH global harmonisation efforts continued through virtual meetings

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FDA: Institutional Review Board (IRB) Review of individual patient expanded access requests for Investigational Drugs and biological products during the COVID-19 public health emergency

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EMA: European Medicines regulatory network COVID-19 business continuity plan

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Finland: Act on secondary use of health data will not be applied to clinical trials

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FDA: Inspections of CDER-led or CDRH-led combination products

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FDA: FDA Guidance on conduct of clinical trials of medical products during COVID-19 public Health Emergency

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PIC/S: Inspection of health based exposure limit (HBEL) assessments and use in quality risk management

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EC: MDR and IVDR implementing measures rolling plan

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FDA: Temporary policy on prescription drug marketing act requirements for distribution of drug samples during the COVID-19 public health emergency

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FDA: Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19) public health emergency (Revised)

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WHO: Good reliance practices in regulatory  decision-making, high-level principles and  recommendations

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TGA:Proposed changes to the medical device Essential Principles for safety and performance

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Philippines FDA: Draft guidance on the issuance of foreign cGMP clearance

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EMA: Guidance on remote GCP inspections during the COVID19 pandemic

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EC: MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product as well as on devices manufactured using TSE susceptible animal tissues

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EMA: Highlights of Management Board: June 2020 meeting

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FDA: Conversion of ANDA approval to tentative approval for patent infringement

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FDA: FDA Permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD

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FDA: FDA warns of newly discovered potential drug interaction that may reduce effectiveness of a COVID-19 treatment authorized for emergency use

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CDSCO: Guideline for conducting BA/BE studies during Covid-19 pandemic

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FDA: Statistical considerations for clinical trials during the COVID-19 public health emergency

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FDA: Patient-Focused drug development: Collecting comprehensive and representative input

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FDA: Coronavirus (COVID-19) Update: FDA takes additional action to harness real-world data to inform COVID-19 response efforts

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MHRA: MHRA suspends recruitment to COVID-19 hydroxychloroquine trials

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DKMA:Suspension paracetamol for children no longer prescription-only

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FDA: Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing

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FDA: Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices — Questions and Answers

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EMA: European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines

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TGA: Proposed delayed commencement of certain medical device regulatory changes

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Japan: Addition of pharmaceutical and special medical device manufacturing businesses, to core designated business sectors subject to inward direct investment screening

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TGA: Transition to new GMP requirements for medicinal products A notice about the implications of adopting the PIC/S Guide to GMP PE009-14

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FDA: Community-Acquired bacterial pneumonia: Developing drugs for treatment guidance for industry and hospital-acquired bacterial pneumonia and ventilatorassociated bacterial pneumonia: Developing drugs for treatment (Guidance for Industry)

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FDA: Review and Update of device establishment inspection processes and standards

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EMA: Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials

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FDA: Development of anti-infective drug products for the paediatricpopulation (draft guidance)

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FDA: Unique Device Identification, policy regarding compliance dates for class I and unclassified devices and certain devices requiring direct marking

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NPRA Malaysia: Guidance document for preparation of Good Manufacturing Practice (GMP) inspections on traditional medicines, health supplements and cosmetics manufacturers

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