Regulatory News - November
COVID-19 related news
New FDA EUA guidance for COVID-19 vaccines.
The FDA has released a new guidance for industry regarding Emergency Use Authorization for Vaccines to Prevent COVID-19, available here.
Remdesivir received FDA approval for COVID-19 treatment.
The FDA has given full approval to the first drug to treat COVID-19. The antiviral Veklury (remdesivir, Gilead Sciences) received approval on 22 October to treat older children and adults who are hospitalized with COVID-19.
The CHMP started two rolling reviews for two potential vaccines for COVID-19.
EMA’s human medicines committee, the CHMP, has started two rolling reviews of data for two potential vaccines for COVID-19 (developed by AstraZeneca in collaboration with the University of Oxford and by BioNTech in collaboration with Pfizer, respectively). The start of the rolling reviews means that the committee has started evaluating the first batch of data on the vaccine candidates, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccines’ safety and effectiveness, as much of the evidence is still to be submitted to the committee.
The EMA received the application for the marketing authorisation of Dexamethasone Taw for COVID-19.
EMA has started evaluating the application for the authorisation of Dexamethasone Taw for treating hospitalised adult patients with COVID-19. The application, from Taw Pharma, will be evaluated by the CHMP according to an accelerated assessment timetable. This will enable the CHMP to issue an opinion on the benefits and risks of Dexamethasone Taw within the shortest possible timeframe.
Other news
IME (Important Medical Events) list updated with inclusion/exclusion criteria.
The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development of an IME list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day-to-day PV activities of stakeholders in the European Union. The IME list is intended for guidance purposes only. Inclusion/exclusion criteria for the IME list were developed during review of the current list for maintenance related to MedDRA Version 12.1. They have been updated to the current version of MedDRA. The criteria – and the proposed additions and deletions to the upversioned list – were based on the official ICH definition of seriousness and of an IME. Click here for further information.
With new draft guidance, the FDA moves towards uniform post-marketing reporting.
A new FDA draft guidance on postmarketing requirements and commitments is available. The guidance details how drug and biologics marketers will use two forms for online submission of annual status reports and other required postmarketing information. Comments on the draft guidance can be submitted by 21 December 2020.
TransCelerate Biopharma has a new page dedicated to the Interpretation of Pharmacovigilance Guidances and Regulations Solutions.
Click to learn about the Reference Safety Information Guidance Q&A, findings on implementation challenges, and more.
The IMDRF proposed updates to its guidance on post-marketing clinical follow-up for medical devices.
The International Medical Devices Regulators Forum (IMDRF) has recently proposed an update to its guidance on post-marketing clinical follow-up for medical devices. The update is currently open to comments. The consultation will close on 19 December 2020.
EMA guideline on registry-based studies - launch of public consultation.
EMA has published its draft guideline on registry-based studies for public consultation. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence. Patient registries are databases containing quantitative and qualitative data about patients who are affected by a particular condition. The guideline addresses methodological, legal and operational aspects in the use of registry-based studies to support regulatory decision-making. Stakeholders are invited to send their comments via an online form by 31 December 2020.