“Historically, enforcement of GMP norms in India has faced challenges, including inadequate inspections and limited resources. The true measure of success will be the consistent application of these standards across the industry.” GSK India’s former executive vice-president Salil Kallianpur on important regulatory changes in the country throughout 2024 and their impact on industry moving forward. Find out more: Key India Regulatory Advances To Watch In 2025
“I know the Republican members were not happy with the premium stabilization, but if they decided to withdraw it and premiums were allowed to rise in Part D, beneficiaries would see their costs for coverage rise and would likely blame the Trump administration.” Vanderbilt University professor Stacie Dusetzina on the difficult choice facing the Trump administration on whether to keep the Part D Premium Stabilization Demonstration program in the hope of avoiding blame for premium increases. Find out more: ‘Not A Good Look’: Premiums Could Jump If Trump’s CMS Drops Part D Demo
“The sort of approach we’re looking at taking [is] using a central control site in representing that activity across different sites,” which would “enable legal tests to be undertaken, but trying to avoid the duplication and confusion of inspecting multiple sites.” MHRA deputy director of innovation Louise Knowles on the UK’s upcoming regulatory framework that will enable medicines to be manufactured at the point-of-care or using modular manufacturing methods. Find out more: MHRA: New UK Point Of Care Legislation Will Remove ‘Regulatory Barriers’ To Innovation
“At the federal level, I would not be surprised to see a package of PBM reforms similar to the one that was initially included in the December continuing resolution reemerge when Congress returns to appropriations this spring…Beyond that, however, I do not expect PBMs to be a major focus for lawmakers during 2025. It’s conceivable that they could turn their attention back to PBMs once 2026 rolls around.” Senior fellow at the Brooking Institution’s Center on Health Policy Matthew Fielder on the continued rise of negative sentiments in the US against pharmacy benefit managers (PBM), as well as the possibility of regulatory intervention. Find out more: This Year, PBM-Directed Fury May Once Again Signify Nothing
“In light of the debate to which the package, including supply of critical medicines, has already been subject, the route to authorization of the proposed Critical Medicines Act could potentially be fairly smooth.” Steptoe’s senior counsel Elisabethann Wright on how plans for a new EU Critical Medicines Act might fare depending on the priorities of Poland as it holds the presidency of the Council of the European Union. Find out more: EU Pharma Reform & Reducing Reliance On Asian Imports: What to Expect in 2025
Advancements have been made in creating a new regulatory pathway for ultra-rare disease therapies in the UK, which will “focus on optimizing patient access and facilitating timely treatment options and reimbursement.” Director and Chief Scientific Officer of the Oxford-Harrington Rare Disease Centre Matthew Wood on the launch of a UK pilot scheme, aiming to construct a new regulatory pathway for ultra-rare diseases. Find out more: UK’s Rare Therapies Launch Pad To be ‘Fully Operational’ By Year-End
“By giving a certain market exclusivity period to a minority of products, pharma companies can obtain reasonable profits back from the market based on [a product’s] market value, effectively encouraging R&D innovation, filling gaps in the medicines on the domestic market and meeting urgent needs in the clinic.” A spokesperson for the National Medical Products Administration on China’s State Council outlining a range of new policies on marketing exclusivity and reimbursement. Find out more: Broad New China Policies Aim To Improve Market Access
“We have to be willing to change as circumstance change, as data change, so long as we remain within our legislative authority, the safe and effective for intended use guardrails if you will…We’ve got to find new ways, if they’re more efficient, if they’re more predictable, if they’re going to protect the safety and effectiveness.” CDER Deputy Director Douglas Throckmorton on his retirement, artificial intelligence and the US FDA’s greater willingness to change course than it is given credit for. Find out more: Retiring CDER Deputy Director: Misconception That US FDA Regulators Cannot Change
“We strongly thought that the conversion [of Elevidys] to full approval, was not a good decision, was not sound, was not based on evidence and that would have been an opportunity for the commissioner to set some guardrails and to insist on a higher standard of evidence for approval, for accelerated approval, to set a tone.” Director of Public Citizen’s Health Research Group Robert Steinbrook on the responsibility of the US FDA commissioner to set approval standards, in response to the question whether the outgoing commissioner, Robert Califf, gave too much deference to center directors. Find out more: Califf: US FDA Center Directors Should Engage With Staff Earlier To Avoid Public Disagreements
“The European Union has positioned our sector as one of the strategic industrial sectors in Europe. That is why we believe that the current moment is unique, with a scenario of opportunities that both the sector and the country must know how to take advantage of.” Farmaindustria’s director general Juan Yermo on the apt timing of Spain’s new pharmaceutical strategy, as it coincides with the deployment of the European pharmaceutical strategy and the European Commission’s Draghi report. Find out more: Spain Bets On News Pharmaceutical Strategy To Boost Access And Innovation
