Tag Archives: Regulatory

Former EMA Head Back in the Regulatory Saddle

By Julian Upton | Published: January 17, 2011
His decade-long tenure as head of the European Medicines Agency (EMA) may have ended, but Thomas Lönngren is already back in the regulatory saddle as a strategic advisor to NDA Group, an independent consulting group focused on reducing wasted drug development costs, ensuring new medicines get to market faster, and “improving the performance of the [...]
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Exclusive Interview: The European Medicine Agency's Thomas Lönngren

By William Looney | Published: December 14, 2010
The European Medicines Agency (EMA) is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs. In return, EMA has made a virtue of necessity. It filled the regulatory [...]
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A Fine Line Between Regulation and Evolution

By Julian Upton | Published: December 1, 2010
The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Ansis Helmanis asks — is industry prepared to adapt or challenge? On September 17, the FDA and CMS jointly issued a Federal Register (FR) notice that they were establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when [...]
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Compliance and Disclosure Risks on Anti-Competitive Promotional Spend: Is EuroLand Set to Follow the US?

By William Looney | Published: November 24, 2010
New Cegedim survey documents whether European industry is ready for the challenge. Making sense of the promotional spend and anti-corruption compliance burden is emerging as a key strategic issue for pharma — not just in the US but in the global market space as well, where regulatory safeguards are still porous. New survey research just published [...]
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Drug Payment Reform in China: Now That's a Mass Market

By William Looney | Published: November 10, 2010
The task of building drug access for one billion new customers in China is probably this decade’s grandest public policy experiment.  It is taking place largely behind the scene in a series of often tense exchanges between Beijing and local governments – the dialogue is worth watching for the long-term commercial implications in what all [...]
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