WHO drafts guidance for pharma supply chain tracking

International – WHO ACT-Accelerator prioritizes global vaccine approach

The importance of a global approach to vaccine development and production, with a focus on collaboration, was a topic of a technical update and...
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...
WHO drafts guidance for pharma supply chain tracking

International – WHO Warns of Falsified Leukemia Drug in Supply Chain

The World Health Organization issued a warning about fake versions of Iclusig (ponatinib) that have been circulating throughout Europe and the Americas. A wholesaler in...

International – EMA and Korean Ministry of Food and Drug Safety to share confidential...

EMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have signed an agreement that allows them to share confidential information...
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...
Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

International – ICH Adds Four New Regulatory Observers

Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals...
WHO drafts guidance for pharma supply chain tracking

International – WHO takes stock of global COVID-19 R&D progress

Researchers, developers and funders from across the globe attended the two half-day virtual summit on 1 and 2 July to examine the progress made...
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...
Top 9 Companies in the Diagnostics Market

International – Top 9 Companies in the Diagnostics Market

Add some market clearances; a rebranding; a merger or two; and some collaborations; and you’ve got a recipe for some of the most powerful...

International – Coronavirus : la pandémie dope le trafic de produits pharmaceutiques

Antalgiques, corticoïdes, anesthésiants mais aussi masques, gants, lunettes, thermomètres : près de 20 millions de produits pharmaceutiques de contrebande ont été saisis depuis février au Moyen-Orient et...

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