News from the world

10

Aug

EMA issues updated guidance on shortage prevention plans ahead of legal deadline

The European Medicines Agency (EMA) has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products.

MAHs must submit these plans to national competent authorities upon request and are required to implement them by mid-2027 under the new EU pharmaceutical legislation.

The agency explained that the goal of the SPPs is to identify vulnerabilities within medicine supply chains and ensure that appropriate measures are in place to prevent, mitigate, or manage any risks that could lead to shortages...[EMA - RAPS]

21

Aug

EDQM - Update to the guidance for electronic submissions of CEP applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated the guidance PA/PH/CEP...

14

Aug

FDA’s GDUFA IV commitment letter supports onshoring of generic drug manufacturing

The agency wants to increase the fee starting in fiscal 2028 for all foreign API, finished dosage form,...

11

Aug

UE approva acquisto di Recordati da parte di GBL e CVC

La Commissione europea ha approvato, ai sensi del Regolamento UE sulle concentrazioni,...

10

Aug

Wise Equity investe in E-Pharma Trento

Wise Equity, società di gestione del fondo Wisequity VI, e Unifarm, azionista unico...