News from the world
WHO is releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.
WHO calls on regulators and governments to:
detect and remove from circulation in their...
FDA Updates Policy Manual on Voluntary Withdrawal of Approved ANDAs
The FDA has updated its Manual of Policies and Procedures (MAPP) concerning receiving and processing...
EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met...
EMA pubblica la linea guida su classificazione dei medicinali veterinari ai fini della prescrizione
Il Comitato per i medicinali veterinari (CVMP) dell’EMA ha adottato la Guideline on the application...
ICH adopts Q13 guideline on continuous manufacturing
AIFA - Aggiornamento modalità assolvimento imposta di bollo relativa agli iter amministrativi dell’Ufficio Ispezioni e Autorizzazioni GMP Materie Prime
Applicazioni biotecnologiche. Gli aspetti normativi e i progetti INAIL
ICH touts adoption of continuous manufacturing, safety reporting guidelines
Frequent Deficiencies In GMP Inspections
FDA official discusses benefits, challenges of remote inspections
Europe needs a strong EU-based API industry to achieve strategic autonomy for its health system.
FDA: Most drug GMP warning letters in FY2022 stemmed from onsite inspections
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