News dal mondo
Brazil's ANVISA to Eliminate Backlog of Applications
Brazilian drug regulator ANVISA said Wednesday at RAPS' Regulatory Convergence that it would eliminate a backlog of new and generic drug applications by January 2019.. .[RAPS]
EMA Enters New Phase of Brexit Preparations
The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit...
FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs
Too many Americans struggle with the high cost of drugs. In some cases, patients go without needed medicines. This is why drug pricing is a matter...
RISK THAT EUROPEAN COUNCIL WILL “NEUTER” SPC MANUFACTURING WAIVER AND GIVE FOREIGN (NON-EU) MANUFACTURERS STRONG ADVANTAGE OVER EU-BASED MANUFACTURERS
SPC manufacturing waiver, proposed by the European Commission, in jeopardy as vested interests continue to hamper progress on achieving a workable...
Comunicazione EMA sulla revisione dei sartani
Le autorità dell'Unione Europea stanno sottoponendo la società cinese Zheijiang Huahai a una più stretta supervisione a seguito di ispezioni...