Posted by EMA starts rolling review of remdesivir for COVID-19
EMA: CHMP recommended the suspension of all ranitidine medicines in the EU
FDA: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment
FDA: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
EMA: COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
CDSCO: Extension of CoPP validity by six months
TGA: Post-market review of face masks
TGA: Pharmacovigilance Inspection Program metrics report: Jan – Dec 2019
FDA: Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS)
UK MHRA: New website for reporting medicines side effects and equipment incidents on coronavirus
FDA: Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under section 506J of the FD&C Act during the COVID-19 public health emergency
FDA: FDA cancels its proposal for devices referencing drugs
EMA: EMA task force on big data
EMA: EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
PMDA: Special approval for emergency on Remdesivir for COVID-19
FDA: Update on surveillance inspections during COVID-19
FDA: FDA takes new actions to accelerate development of novel prevention, treatment options for COVID-19
EC: MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
FDA: FDA Guidance on conduct of clinical trials of medical products during COVID-19 public health emergency
WHO: Frequently asked questions by the manufacturing, trial and testing organizations in connection with some of their constraints faced during the Covid-19 outbreak
EMA: Decision of the executive director on fee reductions for Good Manufacturing Practice (GMP) on-site inspections due to COVID-19 pandemic
EC: 14th Notified Body under MDR
EMA: International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
FDA: Guidance on conduct of clinical trials of medical products during COVID-19 public health emergency
TGA: Post-market evaluation of serology-based point of care tests
TGA: End of pre-approval process for ads in specified media
NPRA: Guidance document on verification of translated official document
EMA: EMA’s governance during COVID-19 pandemic
AEMPS and ANSM: Use of hydroxychloroquine in patients with COVID-19, enhanced surveillance for adverse effects
EMA: Post-authorisation procedural advice for users of the centralised procedure
HPRA: Variation implementation times for labelling and leaflet updates to human medicines, update on regulatory flexibility during the COVID-19 pandemic
EMA: Checklist for initial notifications for parallel distribution
EDQM: Updated technical guide for elaborating and using monographs on vaccines and IVMPs now available
UK MHRA: New dedicated yellow card reporting site for medicines and medical devices
FDA: Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the Coronavirus Disease 2019 (COVID-19) public health emergency
UK MHRA: MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK
Department of Health Philippines: Regulation on the conduct of clinical trials for investigational products
Department of Health Philippines: Revised guidelines on the unified licensing requirements and procedures of the Food and Drug Administration
Department of Health Philippines: Amendment in the pilot implementation of eservices portal for License To Operate (LTO) application
CDE: Notice on matters concerning the gradual restoration of on-site services by the Drug Evaluation Center of the State Drug Administration
TGA: Reuse of face masks and gowns during the COVID-19 pandemic
FDA: Draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol.
FDA: Effects of the COVID-19 public health emergency on formal meetings and user fee applications, Questions and Answers
EMA: Commissions independent research to prepare for real-world monitoring of COVID-19 vaccines
AEMPS: Extension of the term of adequacy of the labeling and instructions for use of medical devices because of Brexit
ANSM: ANSM wishes to suspend clinical trials evaluating hydroxychloroquine in patient care as a precaution – Information Point
BfArM: Federal Institute for Drugs and Medical Devices and major functional units of DIMDI merged
Health Canada: Interim order respecting clinical trials for medical devices and drugs relating to COVID-19