Categoria: Italian Regulatory Affairs News
Brazil approves new generics
The Brazilian Regulatory Agency ANVISA has approved two new generics containing active substances for which there were no competitors on the market.
More biosimilars on the Turkish market
Turkey has specialized in biotechnologies, not only to satisfy the strong domestic demands (Turkey is the 6th largest market in Europe, one of the fastest growing markets),but also to…
Virtual healthcare is growing
Healthcare is becoming one of the sectors where virtual reality finds its broadest application. From simulations of surgical techniques and doctors’ training with virtual patients to the treatment…
France assessing risk-benefit profile of bromocriptine
The French regulator ANSM has reassessed the risk/benefit profile of bromocriptine on behalf of the EMA. The active substance is indicated to inhibit lactation after delivery.
Antibiotic resistance, NICE proposes prescription surveillance
The National Institute for Health and Care Excellence (NICE) has brought some stir in the British healthcare system by proposing some measures to tackle resistance to antibiotics.
BfArM informs on further developments on stolen Italian drugs
The German Medicine Agency BfArM announced new developments on the investigations regarding the theft of medicines occurred in Italy at the beginning of 2014.
Pediatric Committee, new recommendations
The Pediatric Committee (PDCO) of the European Medicine Agency has published some recommendations issued during their meeting in January.
EMA to translate product information changes into all EU languages
The European Medicines Agency (EMA) will translate its recommendations into all the official languages of the European Union, as well as into Norwegian and Icelandic; these will…
MD sector growing
Good news also for medical devices; the Italian market data are also very encouraging.
Cosmetics, internal market reduced but exportations increase
The new sale data on cosmetic products in Italy are encouraging. On one side, the internal demand is slightly reduced, with sale proceeds decreasing of 1% compared…