Regulatory Updates-July 2020

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

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Swiss medic: Optimisation of labelling phase for human medicinal products

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EC: Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices

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TGA: GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic

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FDA: Guidance on conduct of clinical trials of medical products during covid-19 public health emergency

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TGA: Reduced annual charges for medical devices listed on the prostheses list

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EC: French notified body GMED designated under MDR

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 DKMA: Extraordinary measures for clinical trials due to COVID-19

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Swiss medic: Public feedback on implementing eCTD v4.0

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EMA: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – questions & answers

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ICMRA: Preclinical and clinical data required to support proceeding to Phase 3 clinical trials

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 FDA: Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of paediatric patients

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EC: Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials1 following the withdrawal of the United Kingdom from the EU

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TGA: Australia’s first COVID treatment approved

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Philippines FDA: Interim guidelines governing the issuance of permit to register drug importers for foreign drug manufacturers

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TGA:  Regulation of thermometers and other temperature measuring medical devices and products for Covid-19

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FDA: Providing regulatory submissions for medical devices in electronic format

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EMA: EMA finalises opinion on presence of nitrosamines in medicines

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EC: Clinical evaluation assessment report template for medical device

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FDA: Coronavirus (Covid-19) update, first emergency authorization for sample pooling in diagnostic testing

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 EMA: Guideline on the quality of water for pharmaceutical use

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FDA: Enforcement policy for viral transport media during the coronavirus disease 2019

(Covid-19) public health emergency

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 TGA: Actual and potential harm caused by medical software

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Philippines FDA: Guidance for application and transactions during Covid-19 restrictions

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TGA: Directing advertising exclusively to health professionals

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EMA: COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines

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FDA: Multiple function device products: policy and considerations

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TGA: Delays to the commencement of certain medical device regulatory changes

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FDA: Pregnancy, lactation, and reproductive potential, labelling for human prescription drug and biological products

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FDA: Setting endotoxin limits during development of investigational oncology drugs and biological products

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FDA: Expiration dating of unit-dose repackaged solid oral dosage form drug products

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Swiss medic: Changeover to electronic submission of notifications of major changes from autumn 2020

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MHRA: Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under UK Medical Device Regulations 2002

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FDA: Prescription Drug User Fee Rates for Fiscal Year 2021

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