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China has drafted market exclusivity rules for rare disease and pediatric drugs. Rare disease treatments could receive four to seven years of exclusivity, while pediatric drugs may see one to two years, based on the product category and launch timingCompanies must apply for exclusivity during product registration, and applicants are required to ensure steady supply levelsPediatric and rare disease exclusivity can’t be combined. If a product’s exclusivity period overlaps with clinical data protection, it will begin after data protection ends
Abbott’s Nutrition business is breaking off to become its own publicly traded company by the end of 2027The new Nutrition company expects to pull in around $8.5 billion in annual salesIt will focus on metabolic health, wellness, and prevention, serving both developed and emerging markets
Maruho struck a deal with Incyte to bring ruxolitinib cream to South Korea for atopic dermatitisThe Japan-based company will handle development, manufacturing, and commercialization activitiesRuxolitinib cream, a dual JAK1/JAK2 inhibitor, is already approved for vitiligo and atopic dermatitis in the U.S. and Europe
Roche and Hansoh Pharmaceutical inked a massive $15 billion deal, focusing on cutting-edge antibody-drug conjugates (ADCs), marking the second ADC-centered arrangement between the two playersThe pact covers two preclinical assets from Hansoh, as well as multiple programs stemming from Hansoh’s tech platformOn the same day, Roche hit pause on future investments in Germany, citing broken trust from recent cost-cutting measures
The UK’s National Audit Office (NAO) will begin inquiries into the costs and value for money of the UK-U.S. pharmaceutical pricing agreement, following a request from six parliamentary committee chairs. The watchdog’s move comes amid continued concerns over the government’s refusal to publish the full impact assessment for the deal, citing commercial sensitivityEarlier this year, the Nuffield Trust filed a request for an impact assessment with the Department of Health and Social Care (DHSC). However, its request was denied, as was a follow-up request to review that decisionMeanwhile, in a letter dated September 30, 2026, to Layla Moran MP, Chair of the House of Commons Health and Social Care Committee, the NAO Comptroller and Auditor General, Gareth Davies, confirmed that he had instructed his team to make preliminary inquiries into the agreement. He said he would write again to the committee chairs once the initial inquiries were complete
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy setting out plans to accelerate access to safe and effective medicines, strengthen real-world safety monitoring and modernize regulation for artificial intelligence (AI), personalized medicines and advanced therapies“Our 2030 Strategy sets out how, working with our partners across health and life sciences, we will translate scientific and technological innovation into better health outcomes for people across all four nations of the UK,” stated MHRA Chief Executive, Lawrence TallonOverall, the Strategy spans several areas, including patient-centered regulation, operational performance, medicines safety, regulatory innovation, scientific excellence, medical technologies, international partnerships and workforce development
The UK Department of Health and Social Care (DHSC) has published minutes from a July meeting reviewing the operation of the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), revealing that principles for the next agreement have been agreed, including a seven-year termThe meeting also reviewed the implementation of the UK-U.S. pharmaceutical pricing arrangement, NHS medicines spending targets and a slowdown in growth for newer medicines, which fell from around 14% at the end of 2024 to below 5% in incomplete Q1 2026 data, compared with a 6.8% forecast at the time of negotiationsThe review also highlighted plans to extend the deadline for a national local formulary minimum data set to January 2027, delay a substantive NHS England commercial framework consultation until December 2026, and shift the VPAG Investment Program towards demonstrating measurable outcomes
Last week, NAVLIN Daily brought you key market access developments from across the globe In the U.S., PhRMA challenged CMS’ GLOBE Model over foreign reference pricing. Across the pond, France unveiled plans for pharmaceutical reimbursement reform and €1.3 billion in drug price cuts for 2027, while Japan signaled limited scope to respond to the U.S. MFN policy through higher drug prices Spain’s Congress has agreed to process the government’s proposed Draft Law on Medicines & Health Products under the urgent parliamentary procedure, Article 93.2 of the Congress Rules of Procedure
The Pharmaceutical Research and Manufacturers of America (PhRMA) has filed a lawsuit against the Centers for Medicare & Medicaid Services’ (CMS) recently finalized GLOBE Model, arguing the demonstration exceeds the agency’s legal authority and unlawfully imposes foreign reference pricingThe lawsuit contends that GLOBE is not a legitimate payment model test under Section 1115A but instead a sweeping drug-pricing policy that would replace Medicare’s market-based reimbursement framework with mandatory rebates tied to prices in 19 comparator countriesPhRMA also argues the model violates statutory and constitutional limits on executive authority, could undermine pharmaceutical innovation and patient access, and is asking the court to declare the rule unlawful and prevent its implementation
Japan has limited scope to respond to the U.S. most-favored-nation (MFN) policy through higher pharmaceutical prices, a senior Ministry of Finance (MOF) official has told Jiho, while backing full implementation of the country’s FY2027 off-year national health insurance (NHI) price revision“There isn’t all that much we can do,” Kentaro Katayama, the MOF’s newly appointed budget examiner responsible for health, labor and welfare and broader social security spending, told Jiho when asked about possible measures under the April 2027 revisionKatayama acknowledged concerns that the U.S. MFN policy could affect access to medicines in Japan, but questioned claims that Japanese drug prices are particularly low compared with other markets. He pointed to arguments that U.S. wholesale acquisition costs can be substantially reduced by rebates paid through pharmacy benefit managers. “We need to calmly discuss, based on data, whether Japanese drug prices really are exceptionally low, including in comparison with Europe,” he said, calling for comparisons based on prices after rebates
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