On the 11th of June, the FDA has organised a widely attended webinar on “Identification of Medicinal Products: Path to a Global Implementation”. UNICOM is happy to see that some important work released to date by UNICOM (such as the Gap Analysis Report and the 34 substances identified in close collaboration with the WHO-Uppsala Collaborating Center to be the base for the UNICOM products pilot list) is taken into consideration by the FDA.
This is the consequence of preliminary discussions with the FDA which led to a joint presentation of WHO-UMC and FDA at the ISO/CEN W6 2nd of June meeting which also provided important inputs on how UNICOM plans to use EDQM (and derived SPOR) to determine the (administrable) dose form for the production of the Pharmaceutical Product Identification (PHPID).
On the 8th of June UNICOM also organised its first Transatlantic event, which brought together 25 experts to debate on the situation in the US (with US FDA representatives), in Europe (with an EMA representative) and globally (with a WHO UMC representative).
You can watch here the video of the 11th of June FDA webinar.