Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can...
Mylan recalls 15 lots of blood-pressure drug containing valsartan

International – Mylan recalls 15 lots of blood-pressure drug containing valsartan

Mylan (NASDAQ:MYL) starts a voluntary U.S. recall of select lots of Valsartan-containing products due to trace amounts of an impurity that's classified as a probable human...
Intracranial Hemorrhage Detection Software Receives FDA Clearance

International – Pfizer to increase some drug prices in 2019

Pfizer announced Friday it is raising the prices of dozens of drugs in 2019 after bowing to pressure earlier this year from President Donald Trump and...
SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

International – EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday...
Australia and Canada Extend Mutual Recognition Agreement to APIs

International – Australia and Canada Extend Mutual Recognition Agreement to APIs

Australia and Canada have expanded their mutual recognition agreement (MRA) to cover active pharmaceutical ingredients (APIs). The change means TGA will accept good manufacturing...
GSK’s says depot HIV injection works over three years

International – GSK’s says depot HIV injection works over three years

GlaxoSmithKline’s bid to develop an alternative to daily dosing of HIV drugs has made further progress, with new data backing the efficacy of a...
Valsartan prices double after recall

International – Valsartan prices double after recall

Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a...
India Hews Closely to WHO GMP Guidelines in Planned Changes to Schedule M

India – India Hews Closely to WHO GMP Guidelines in Planned Changes to Schedule...

India is planning to overhaul its legislation on good manufacturing practices (GMPs). The draft text draws heavily on the World Health Organization’s (WHO) GMP...
EMA Takes Further Action in Ongoing Review of Tainted 'Sartans'

International – EMA Takes Further Action in Ongoing Review of Tainted ‘Sartans’

China's Zheijiang Huahai Pharmaceuticals (ZHP), the company at the center of the tainted valsartan crisis, will face increased scrutiny over other substances they produce,...
Les faux médicaments, un fléau pour l'Afrique

Afrique – Les faux médicaments, un fléau pour l’Afrique

Cet anti-palu avait tout l'air du médicament fiable… pourtant, c'est une contrefaçon. La dose qu'il contient de quinine, à la base du traitement anti-malaria,...

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