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Policy

Canada’s New Pharmacare Committee “Excludes” Industry

As mandated by the recent Pharmacare Act in Canada, a new committee will make recommendations on how Canada can provide universal drug coverage to it citizens.

Is The EU Recreating A Different Monster Of A Regulatory Labyrinth?

Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?

Supplement Firms Make Good Neighbors Knocking On State AGs’ Doors

“The first time we have a contact with them, if and when someone complains, is not because you're in trouble, but you already have a pre-existing relationship,” says former Maryland state AG Doug Gansler.

England: NICE Finds Its Advice Can Cut Drug Appraisal Times By Three Months

The health technology assessment institute said its “unique insights” could help companies effectively prepare for their appraisals, potentially streamlining their path through the process, and helping to get innovative technologies to patients faster.

Industry Support Key To US FDA’s Prospects Under Trump – Califf

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

AAM Urges Trump Administration To Take Action For Off-Patent Sector

In the wake of a US presidential election that saw Donald Trump returned to power, the US Association for Accessible Medicines has called for the next administration to take action to help support the generics and biosimilars market.

IGBA Kicks Off Global Biosimilars Week 2024

Running from 11-14 November, the fifth annual Global Biosimilars Week awareness campaign has been launched by the IGBA, with the international off-patent association this year focusing on advancing access.

Cosmetics Industry May Face Tariffs, Trade Agreement Challenges In New Trump Administration

Tariffs are expected again under a second Trump Administration and the future of the Americas Partnership for Economic Prosperity is uncertain, says the Personal Care Products Council, which will continue to push for regulatory alignment and lower trade barriers.

‘The Right Call:’ Australia’s PBAC Addresses ‘Unprecedented’ Backlog With Extra Meeting

The government’s decision for the Pharmaceutical Benefits Advisory Committee to hold an extra meeting in 2025 has been welcomed by Medicines Australia, which says that Australians already wait on average 466 days from the time a medicine is approved to when it is subsidized.

EU Council Adopts Wastewater Directive Threatening Generics Industry

Despite calls to amend the Urban Wastewater Treatment Directive to protect essential and critical medicines, the EU Council gave its final approval.