Posted by EMA: Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic
Swiss medic: Optimisation of labelling phase for human medicinal products
EC: Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
TGA: GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic
FDA: Guidance on conduct of clinical trials of medical products during covid-19 public health emergency
TGA: Reduced annual charges for medical devices listed on the prostheses list
EC: French notified body GMED designated under MDR
DKMA: Extraordinary measures for clinical trials due to COVID-19
Swiss medic: Public feedback on implementing eCTD v4.0
EMA: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – questions & answers
ICMRA: Preclinical and clinical data required to support proceeding to Phase 3 clinical trials
FDA: Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of paediatric patients
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
TGA: Australia’s first COVID treatment approved
Philippines FDA: Interim guidelines governing the issuance of permit to register drug importers for foreign drug manufacturers
TGA: Regulation of thermometers and other temperature measuring medical devices and products for Covid-19
FDA: Providing regulatory submissions for medical devices in electronic format
EMA: EMA finalises opinion on presence of nitrosamines in medicines
EC: Clinical evaluation assessment report template for medical device
FDA: Coronavirus (Covid-19) update, first emergency authorization for sample pooling in diagnostic testing
EMA: Guideline on the quality of water for pharmaceutical use
FDA: Enforcement policy for viral transport media during the coronavirus disease 2019
(Covid-19) public health emergency
TGA: Actual and potential harm caused by medical software
Philippines FDA: Guidance for application and transactions during Covid-19 restrictions
TGA: Directing advertising exclusively to health professionals
EMA: COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
FDA: Multiple function device products: policy and considerations
TGA: Delays to the commencement of certain medical device regulatory changes
FDA: Pregnancy, lactation, and reproductive potential, labelling for human prescription drug and biological products
FDA: Setting endotoxin limits during development of investigational oncology drugs and biological products
FDA: Expiration dating of unit-dose repackaged solid oral dosage form drug products
Swiss medic: Changeover to electronic submission of notifications of major changes from autumn 2020
MHRA: Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under UK Medical Device Regulations 2002
FDA: Prescription Drug User Fee Rates for Fiscal Year 2021