Regulatory
With EU MDR/IVDR review proposals out, UK MHRA progress on a premarket regulation and, up ahead, a prospective consultation on accepting the CE marking indefinitely, now is a good time to assess EU-UK regulatory positions for the benefit of UK industry, says ABHI director Steve Lee.
A new report identifies opportunities to implement the 3Rs principle in India, calling for a waiver of redundant animal testing for generics and NCEs/NBEs and alignment with global regulatory frameworks. Will India shift gears to adopt harmonized NAM-first policies?
The CHMP has delivered a negative trend vote on the US firm's filing for Daybue.
Cell and gene therapy is shifting into a new phase, as maturing commercial launches, rising big pharma participation and regulatory momentum replace hype and skepticism.
India’s budget backs plans to scale production of biologics and biosimilars, shore up its clinical trials network and strengthen the regulatory framework. Customs duty exemptions given to several big pharma therapies, including those of Novartis and Takeda.
The company said the FDA placed the hold on RGX-111 and RGX-121 after a patient in its RGX-111 trials developed a brain tumor, the cause of which remains under investigation.
The US pharmaceutical market is critical for European pharma companies, but new policies introduced by the Trump administration are creating an increasingly complex and uncertain environment for them.
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.
Generics Bulletin reviews global regulatory developments across the world.
Brazil’s new drug pricing rules, which come into force in April, are intended to better recognize incremental innovation and give more predictability to the pricing of biosimilars.
The UK MHRA will soon consult on allowing CE-marked devices indefinite access to the Great Britain market. Meanwhile, the EU has at last moved to make the MDR/IVDR more user friendly. Taylor Wessing partner Alison Dennis reflects on how these events could influence evolving UK medtech legislation.
The firm's type 1 diabetes drug has been given the green light by the European Commission.