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News dal mondo

18

Feb

cGMP Non-Compliance Recap 2020

The pandemic changed the way we lived our lives, and regulatory agencies were no exception to that rule.

 In early March 2020, the US Food and Drug Administration (FDA) announced it was postponing most inspections outside the United States.

However, by the end of 2020, FDA and the European Directorate for the Quality of Medicines & HealthCare (EDQM) had managed to complete over 2,200 inspections across the world.

 The FDA was the most active locally, and issued almost 40 warning letters to drug manufacturers based in the US. Consistent with the previous years’ trend, warning letters in the US were followed by those issued to manufacturers in India (13) and China (7)....[PharmaCompass]

22

Apr

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

he European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete...

20

Apr

US GDUFA III: Use MDUFA model to create competition in generic drug markets

To design an effective financing system for generic drug approvals, the FDA must balance the need...

20

Apr

Pharmaceutical reshoring: a strategic necessity

More than a year into the COVID-19 crisis, the novel coronavirus continues to disrupt our societies,...

19

Apr

Covid-19 ministro Speranza firma nuove Ordinanze per contenere la diffusione del virus

Il Ministro della Salute, Roberto Speranza, sulla base dei dati e delle indicazioni...

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