Regulatory News - August
COVID19 vaccines
The FDA has issued a new guideline for industry on COVID19 vaccines.
EMA literature search related to COVID-19 potential treatment.
EMA added nine additional active substances (chloroquine, darunavir, emtricitabine-tenofovir, filgrastim, ivermectin, nitric oxide, oseltamivir, prednisone and ritonavir) to the Medical Literature Monitoring (MLM) list which are being investigated as potential treatments for COVID-19, and for which there are multiple marketing authorisation holders in the EEA.
It is also adding COVID-19-related search terms to its regular literature searches for six active substance groups (azithromycin, ciclosporin, dexamethasone, hydrocortisone, ribavirin and prednisolone) that were already included in the service. The change is intended to enable EMA to detect reports related to the use of these drugs to treat COVID-19.
COVID-19-related literature searches commenced on 1 June 2020 in EMBASE, and will commence on 1 July 2020 in EBSCO.
Upcoming EMA virtual Workshop on benefit-risk of medicines used during pregnancy and breastfeeding.
The workshop will be broadcast live on EMA’s website on 22 September 2020. You can follow the broadcast by clicking on the ‘multimedia’ tab on the event page on the day of the event. In addition to the online broadcast, there is some - very limited - capacity to participate in the virtual meeting room (Adobe).
Participation in this virtual meeting room is subject to prior application. To submit an expression of interest, please click on this link and complete the online form.
The deadline for expression of interests is 17 August 2020, 5pm CET.
The European Commission has recently released a road map document on pharmaceutical reform for consultation
It will address:
- the life cycle of medicines from R&D to authorisation and patient access
- how to put scientific and technological advances into practice
- how to fill market gaps (e.g. new antimicrobials)
- lessons learnt from COVID-19 on how to better prepare for future pandemics.