Categoria: Italian Regulatory Affairs News
Mapping the risks in GMP inspections
The Italian Medicine Agency (AIFA) informed all manufacturing sites and importers of active substances that the API Inspection Unit is mapping the risks in the frame of…
Changes to the National Network of Pharmacovigilance
The Italian Medicine Agency informed all concerned parties that some changes have been introduced to the National Network of Pharmacovigilance (RFN) allowing the registration of reports of suspected adverse reactions occurred on…
New monitoring registers
Starting from February 23th 2015 a new web sheet regarding the medicinal product containing the active substance simeprevir has been made available on the web platform of…
Update of authorized prescription centres
The list of centres authorized by the Italian regions to the prescription of drugs for the treatment of hepatitis C has been updated again.
Non compliance for an Indian manufacturing site
Following an inspection by the Portuguese Agency, the pharmaceutical manufacturing site Symed Labs Limited, Telangana, India resulted as not in compliance with the GMP.
Medical devices, new online database for the FDA
The regulatory agency FDA has launched a new online database that includes all guidelines pertaining to medical device manufacturers with products registered for sale in…
Resistance to antibiotics, Europe and the WHO identify objectives
The first data on the massive use of antibiotics in Europe is now available, which has the purpose of identifying the possible relationships between the…
First-class service at low cost, the WHO praises Singapore
During an official meeting, the Director-General of the WHO praised the national health system in Singapore, for being able to provide first-class health care at…
Hydroxyzine, EMA communication
The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA has concluded the evaluation of medicinal products based on hydroxyzine, an antihistamine approved in Europe for…
Pharmacovigilance, the international situation
An international meeting with the participation of European and African countries bordering the Mediterranean has been the occasion to take stock of the international situation…