Regulatory Updates-May 2020

Posted by

EMA starts rolling review of remdesivir for COVID-19

Read More…

EMA: CHMP recommended the suspension of all ranitidine medicines in the EU 

Read More…                                                              

FDA: Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

Read More…

 FDA: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

Read More…

EMA: COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines

Read More… 

CDSCO: Extension of CoPP validity by six months

Read More… 

TGA: Post-market review of face masks

Read More…

TGA: Pharmacovigilance Inspection Program metrics report: Jan – Dec 2019

Read More…

FDA: Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS)

Read More… 

UK MHRA: New website for reporting medicines side effects and equipment incidents on coronavirus

Read More… 

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

Read More…

FDA: FDA cancels its proposal for devices referencing drugs

Read More…

EMA: EMA task force on big data

Read More…

EMA: EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation

Read More… 

PMDA:  Special approval for emergency on Remdesivir for COVID-19

Read More…

FDA: Update on surveillance inspections during COVID-19

Read More… 

FDA: FDA takes new actions to accelerate development of novel prevention, treatment options for COVID-19

Read More… 

EC: MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745

Read More…

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

Read More… 

WHO: Frequently asked questions by the manufacturing, trial and testing organizations in connection with some of their constraints faced during the Covid-19 outbreak

Read More… 

EMA: Decision of the executive director on fee reductions for Good Manufacturing Practice (GMP) on-site inspections due to COVID-19 pandemic

Read More…

EC: 14th Notified Body under MDR

Read More…

EMA: International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials

Read More…

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

Read More…

TGA: Post-market evaluation of serology-based point of care tests

Read More…

TGA: End of pre-approval process for ads in specified media

Read More… 

NPRA: Guidance document on verification of translated official document

Read More…

EMA: EMA’s governance during COVID-19 pandemic

Read More…

AEMPS and ANSM: Use of hydroxychloroquine in patients with COVID-19, enhanced surveillance for adverse effects

Read More…

EMA: Post-authorisation procedural advice for users of the centralised procedure

Read More…

HPRA: Variation implementation times for labelling and leaflet updates to human medicines, update on regulatory flexibility during the COVID-19 pandemic

Read More… 

EMA: Checklist for initial notifications for parallel distribution

Read More…

EDQM: Updated technical guide for elaborating and using monographs on vaccines and IVMPs now available

Read More…

UK MHRA: New dedicated yellow card reporting site for medicines and medical devices

Read More…

FDA: Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the Coronavirus Disease 2019 (COVID-19) public health emergency

Read More…

UK MHRA: MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK

Read More…

Department of Health Philippines: Regulation on the conduct of clinical trials for investigational products

Read More…

Department of Health Philippines: Revised guidelines on the unified licensing requirements and procedures of the Food and Drug Administration

Read More…

Department of Health Philippines: Amendment in the pilot implementation of eservices portal for License To Operate (LTO) application

Read More…

CDE: Notice on matters concerning the gradual restoration of on-site services by the Drug Evaluation Center of the State Drug Administration

Read More…

TGA: Reuse of face masks and gowns during the COVID-19 pandemic

Read More…

FDA: Draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol.

Read More…

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

Read More…

EMA: Commissions independent research to prepare for real-world monitoring of COVID-19 vaccines

Read More…

AEMPS: Extension of the term of adequacy of the labeling and instructions for use of medical devices because of Brexit

Read More… 

ANSM: ANSM wishes to suspend clinical trials evaluating hydroxychloroquine in patient care as a precaution – Information Point

Read More… 

BfArM: Federal Institute for Drugs and Medical Devices and major functional units of DIMDI merged

Read More…

Health Canada: Interim order respecting clinical trials for medical devices and drugs relating to COVID-19

Read More…