Regulatory

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.

A panel of experts from J&J, UCB and Takeda deliberated on the use of AI and internal processes to strike the right balance between speed and accuracy in MLR reviews that could protect a company from serious repercussions. They also spoke of the need for regulatory systems to catch up.

A panel of experts from J&J, UCB and Takeda deliberated on the use of AI and internal processes to strike the right balance between speed and accuracy in MLR reviews that could protect a company from serious repercussions

Generics Bulletin reviews the latest regulatory developments across the world.

Respondents to the FDA’s questions over biosimilar development did not hold back. So, what is it: product-specific or product class-specific guidance? Or nothing?

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.

Meeting the regulatory gold standard for drug candidates in ultra-rare diseases can be impractical, a regulatory expert says, but greater collaboration and shared insights from regulatory reviews could help find a viable path forward.

A new UK medtech survey sets out industry’s market access and regulatory concerns and makes clear where system users see the need for improvement. There are some grounds for optimism, but the MHRA’s planned rise in regulatory fees could undo some of the good work.

An examination of the global implementation of guidelines from the International Council for Harmonisation by regulators has yielded positive outcomes.

It is time for a much greater focus on pull incentives to ensure viable market conditions for medicines for neglected diseases that are traditionally regarded as unprofitable.