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Policy

IGBA Kicks Off Global Biosimilars Week 2024

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

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 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

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.

Korea Lays Out Roadmap For Use Of AI Across Drug Development

Korea Lays Out Roadmap For Use Of AI Across Drug Development

The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.

Medtechs Applaud UK Life Sciences Fund But  Seek Lowering Of £8M Project Threshold

Medtechs Applaud UK Life Sciences Fund But Seek Lowering Of £8M Project Threshold

The Life Sciences Innovative Manufacturing Fund, set out in the UK budget last month, is live for applications. More UK medtechs would benefit if the cost threshold were scaled down, the industry argues.

EMA Seeks Feedback On COI Policy Changes Following Legal Rulings

EMA Seeks Feedback On COI Policy Changes Following Legal Rulings

The European Medicines Agency is conducting a public consultation on proposed revisions to its policy on how it handles any conflicts of interest of its scientific committee members and experts.

Australian Industry Strikes Deal On Deferred PBS Submissions, Challenges Govt's Capacity Claim

Australian Industry Strikes Deal On Deferred PBS Submissions, Challenges Govt's Capacity Claim

Medicines Australia has expressed skepticism over the Pharmaceutical Benefits Advisory Committee’s claim that in March 2025 it will only be able to assess 32 submissions from companies that want to get their drugs subsidized under the Pharmaceutical Benefits Scheme.

Nordic Medtech Experts Urge More Collaboration On Health Technology Assessments

Nordic Medtech Experts Urge More Collaboration On Health Technology Assessments

European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.

EU HTA Reg: CoI Rules Limit Participation Of Experts In Joint Clinical Assessments

EU HTA Reg: CoI Rules Limit Participation Of Experts In Joint Clinical Assessments

The European Commission has now adopted the third implementing act for the Health Technology Assessment Regulation. This sets out rules for managing conflicts of interest of anyone involved in joint clinical assessments or joint scientific consultations under the regulation.