Coronavirus Prompts IMDRF to Cancel 3 Meetings

Regulatory NewsRegulatory News | 17 February 2020 |  By 

In consideration of the ongoing coronavirus (COVID-19) outbreak, the International Medical Device Regulators Forum (IMDRF) has cancelled three upcoming meetings in Singapore.
The three meetings were to be held from 16-19 March and include the IMDRF-DITTA Joint Workshop on Cybersecurity, IMDRF Stakeholder Forum and the IMDRF Management Committee Meeting.
According to the latest World Health Organization (WHO) situation report, there are now more than 71,000 confirmed cases of COVID-19 around the world and 1,775 total deaths reported.
IMDRF has not said whether the meetings will be rescheduled. The announcement comes after other organizations have cancelled events in response to the outbreak, including major trade shows, sporting events and conferences.
FDA Updates
In a statement Friday, US FDA Commissioner Stephen Hahn said the agency is monitoring the pharmaceutical supply chain for potential disruptions and promoting the development of diagnostics to detect the virus. He said FDA has shared pre-Emergency Use Authorization information with more than 50 developers who have expressed interest in developing diagnostics for COVID-19.
While China is a major supplier of active pharmaceutical ingredients (API) and other raw materials used in drug manufacturing, Hahn notes that “there are no vaccines, gene therapies, or blood derivatives licensed by FDA that are manufactured in China.” According to a hearing last October, China has 230 (13%) of the API manufacturing facilities serving the US, while the US has 510 (28%) and the rest of the world has 1048 (59%). And the number of registered facilities making APIs in China more than doubled between 2010 and 2019.
FDA is in communication with other regulators, including the European Medicines Agency, to look for signs of supply interruptions, Hahn added.
So far, FDA has not acknowledged any coronavirus-related shortages or supply chain disruptions affecting the US, though reports indicate that the Indian generic drug industry has already been affected by higher prices of ingredients imported from China.
But FDA has halted its inspections of API and drug manufacturers in China and has postponed all inspections scheduled for February. In some cases, Hahn said they agency has accepted “other information to inform decisions allowing the products to enter our US market.” Hahn also said that the agency will be postponing most routine surveillance inspections in China that were scheduled for March.


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