News dal mondo
The Ministry of Health of the Russian Federation improves patent protection law
The Ministry of Health of Russia has published a notification on the development of amendments to Federal Law No. 61 of 12.04.2010 "On circulation of medicinal products" ...[GMPNews]
The EU and APIs: New Rules of the Game in Manufacturing
Innovator and generic-drug companies are squaring off on a proposal by the European Commission for an export manufacturing waiver for supplementary...
ICH Q3C(R7) Guideline and Q3C Support Documents available
The ICH Q3C(R7) Guideline, which is the result of an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol in the ICH Q3C(R6)...
Advent International acquisisce Zentiva da Sanofi
Novità rilevanti nel comparto generici: dopo quasi dieci anni all'interno del gruppo Sanofi, Zentiva passa di mano, acquisita dal fondo di private...
EU Generics Group Takes Issue With US Interference on SPC Manufacturing Waivers
Medicines for Europe, which represents the EU's generic and biosimilar medicines industry, raised concerns earlier this month with discussions...