Regulatory Updates-April 2020

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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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EMA: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes

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FDA: FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

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ICH: ICH M1 Points to Consider Working Group and MedDRA MSSO Communication on Coronavirus

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EMA: Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context

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EMA: EMA provides recommendations on compassionate use of remdesivir for COVID-19

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EMA: EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic

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IMDRF: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

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IMDRF: Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

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Philippines FDA: Procedure for FDA clearance of Personal Protective Equipment (PPE) prior to customs release

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EC: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

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EC: MDCG 2019-3 Interpretation of Article 54(2)b rev 1

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UK: Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak

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FDA: Investigational COVID-19 Convalescent Plasma guidance document

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EMA: EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines

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EMA: Questions and answers on regulatory expectations for medical products for human use during the Covid-19 pandemic

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FDA: FDA Authorizes Blood Purification Device to Treat COVID-19

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FDA: Product-Specific Guidance’s for Chloroquine Phosphate and Hydroxychloroquine Sulfate

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FDA: Product-Specific Guidance’s for Chloroquine Phosphate and Hydroxychloroquine Sulfate

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CDSCO: Permission to manufacture oxygen for medical use

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TGA: Expedited recall system for faulty or unauthorised COVID-19 devices

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Malaysia FDA: Permission letter to deliver, install, test and commission and or undertake maintenance of medical device in healthcare and related facilities

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ICH: S11 – Nonclinical safety testing in support of development of paediatric pharmaceuticals

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FDA: Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency

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EMA: Notice to sponsors on validation and qualification of computerised systems used in clinical trials

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UK MHRA: Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak

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UK MHRA: Pharmacovigilance Inspection Metrics Report April 2018 – March 2019

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HPRA: COVID-19 Related Human Research – Expedited Regulatory and Ethical Review

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FDA: Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

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EC: Guidelines on COVID-19 in vitro diagnostic tests and their performance

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FDA: ANDA Amendments and Supplements Reviewed by the Division of Filing Review

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Philippines FDA: Performance testing of antibody test kits with issued special certification

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CDSCO: Relaxation in the notary requirement

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CDSCO: Update on clinical trial requirement fo convalescent plasma treatment for Covid-19

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FDA: Nonbinding Feedback After Certain FDA Inspections of Device Establishments

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UK MHRA: Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak

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Swiss medic: Evaluation of potential nitrosamines in connection with new authorisations

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IMDRF: Principles and practices for medical device cybersecurity

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FDA: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems

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FDA: Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID19) Public Health Emergency

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FDA: Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Guidance for Industry and Food and Drug Administration Staff (draft guidance)

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 EC-MDCG – updated guidance

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TGA: Domestic Good Manufacturing Practice (GMP) inspections during the COVID-19 pandemic

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FDA: Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic

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 EMA: Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis

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EMA: Union procedure on the follow-up of pharmacovigilance inspections

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HPRA:  Guide to New applications and variations to Manufacturer’s Authorisations

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