Asia Pacific
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Pakistan Explains Updated Risk-Based Criteria For GCP Inspections
Pakistan’s drug regulator is hoping that improved transparency on its inspection protocols will help research entities better prepare for good clinical practice inspections.
Australia To Give Consumers More Formal Role In HTA Processes
The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and lifesaving medicines might never be assessed for funding due to “a lack of commercial incentive for pharmaceutical companies.”
BeiGene’s Tevimbra And The End Of The COVID Inspection Era
US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.
Risks For Pharma Industry Remain As BIO Shifts Course On BIOSECURE Act
Trade group’s break from WuXi Apptec allows BIO to reset its lobbying approach under its new CEO but doesn’t negate the business and supply chain disruptions that biopharma would feel from the proposed legislation.
China Biotech Hopes Innovation Wins The Day As Legislative Attacks In US Congress Increase
The latest development shows that BIOSECURE Act is gaining momentum in the US Congress and off Capitol Hill. In the meanwhile, the Chinese biotech sector embraces uncertainty but hopes that common interests in health innovation will prevail in the end.
Japan Drug Price Revision: Cuts, Increases Aim To Balance National Healthcare Costs
Japan will raise reimbursement prices for selected essential and clinically valuable drugs in April, while cutting back prices for a higher than usual number of other products through the broad application of market expansion repricing rules. The overall regular revision will see prices cut by 4.7% on average.
US Senate Advances BIOSECURE Legislation As China Biotech Security Heats Up
The US Senate moves closer to new legislation that would restrict Chinese "biotech companies of concern” from operating in the US, potentially causing broad and far-reaching impact.
Global Pharma Guidance Tracker – February 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
China Lowers GDP Target As VBP And Corruption In Focus At 'Two Sessions'
Amid slack domestic consumption and declining overseas demand, 2024 may be the start of a multi-year slowing in growth for the world’s second-largest economy. In the health sector, volume-based procurement continues to expand while the focus of anti-corruption campaigns appears to be changing.
AIRIS 2024: Global Cooperation A Challenge For Regulation Of AI Products
During the first international symposium on the use of AI in medical products, co-hosted by US and Korean regulators, global experts discussed issues and challenges related to effective development and regulation. Cooperation, flexibility and the need for a "human-centric" approach emerged as key themes in the fast-moving field.
Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'
Lilly’s CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a “false narrative.” The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year.
Three Major Regulators Launch Pilot To Reduce Duplication Of GMP Inspections
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances.
NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act
A parallel assessment mechanism that will allow new medicines in any therapeutic area to be considered for funding sooner is being introduced in New Zealand, where the new coalition government is working to repeal last year’s landmark Therapeutic Products Act.
US Toning Down China CDMO Tension But New Restrictions Emerge
The latest developments in a US Congressional draft bill to curb Chinese biotech operations in the US is separating contract manufacturing and research from gene sequencing service providers, which may give China's major contract players reasons to breathe easy.
Singapore & South Korea’s Recognition Of GMP Inspections To Cut Burden For Companies
A new agreement signed between Singapore’s Health Sciences Authority and South Korea’s Ministry of Food and Drug Safety means drug manufacturers in the two regions will be subjected to fewer duplicative good manufacturing practice inspections.
Doctors’ Protests Intensify In Korea As Essential Healthcare Challenges Highlighted
South Korea’s healthcare services face both longer-term systemic challenges and short-term disruption from ongoing doctor walkouts over government plans to boost medical trainees. Meanwhile, the local pharma industry is calling for new measures to support the supply of essential drugs.
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