India Adds Four Medical Device Types to CDSCO List of Regulated Products

India – India’s CDSCO Seeks Feedback From Users of Online Drug, Medical Device Portals

India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on its Sugam online portal. The consultation is designed to ascertain how users feel...
The Q&A is divided into six sections

International – WHO Opens Consultation on New Biosimilar Q&A

As part of plans to clarify earlier biosimilar guidance, the World Health Organization (WHO) has drafted a new document outlining answers to questions regulators...
9 nouveaux étalons de référence de la Ph. Eur. et 20 lots de remplacement libérés en novembre 2019

International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments

La Direction européenne de la qualité du médicament & soins de santé (EDQM) et l’ANVISA, l’agence brésilienne de surveillance sanitaire, ont annoncé aujourd’hui avoir...
Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal

International – Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal

As part of a preliminary trade deal between the US and Mexico, to update the 24-year-old North American Free Trade Agreement (NAFTA), both sides agreed...
ICH Updates After Singapore Assembly Meeting

International – ICH Offers Updates on Guidelines, Working Groups

In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15...
Thomas Dreyfuss

Emerging Market Access Strategy in the Pharmaceutical Industry the example of Thailand – by...

Thomas is PharmD and started his professionnal activity at WHITE-TILLET where he was trained in International Market Access analysis and process. After a MBA...
Brexit Costs EMA Almost €60M in 2019

International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at...
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...
Information Note Nitrosamine impurities

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...
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...

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