Regulatory Affairs
After the Mother of All Deals: A Blueprint for the Ireland-India Pharmaceutical Corridor Under the EU-India FTA
A commercial-grade blueprint for the Ireland-India pharma corridor under the EU-India FTA: tariffs, HPRA-CDSCO bridges, 2030 projections, policy asks.
Regulatory Affairs
The UK-India CETA: A Deep Dive into Bilateral Pharmaceutical Value Chains, API Trade, and Medicine Price Trajectories
An in-depth commercial analysis of the UK-India Comprehensive Economic and Trade Agreement (CETA), exploring its transformative impact on bilateral pharmaceutical manufacturing, active pharmaceutical ingredient (API) supply chains, and consumer medicine pricing.
Regulatory Affairs
Transatlantic Tariff Siege: EU Pushes US for €150B Exemption List to Protect MedTech and Spirits
As the Turnberry Deal’s 15% tariff baseline takes hold, Brussels has formally requested carve-outs for €150 billion worth of European goods. The stakes are exceptionally high for Ireland’s €13B medical technology industry, where critical components face severe transatlantic margin pressures.
Regulatory Affairs
GEODIS Expands Pharmaceutical Logistics in Poland: Securing Dual GDP and IATA CEIV Pharma Certifications
GEODIS has renewed its IATA CEIV Pharma accreditation in Warsaw and secured GDP certification for its Stryków Dobra contract logistics facility. This dual compliance milestone bolsters Poland’s status as a critical gateway in Europe’s pharmaceutical supply chain.
Regulatory Affairs
Irish EU Council Presidency Prioritizes €10B Biotech Act to Revitalize European Clinical Trials and Sovereign Biomanufacturing
Irish Health Minister Jennifer Carroll MacNeill positions the €10 billion EU Biotech Act as a key priority for Ireland's Council Presidency, aiming to reverse the decline in clinical trials while balancing pharmaceutical incentives against patient access to affordable therapies.
Regulatory Affairs
Addressing the 801-Day Lag: Ireland’s Drug Approval System Demands Urgent Structural Reform
The latest EFPIA Patients W.A.I.T. Indicator report reveals that Irish patients wait an average of 801 days to access newly approved medicines, prompting calls for an overhaul of the HSE and NCPE reimbursement processes and a dedicated mechanism for rare disease orphan drugs.
Regulatory Affairs
The Pill That Promised a Revolution: Why Eli Lilly's Foundayo Is Launching Slower Than Wall Street Expected
Jefferies has revised its debut-quarter US sales estimate for Eli Lilly's oral GLP-1 drug Foundayo (orforglipron) down to $71 million - well below the Wall Street consensus of $130 million and sharply below its own prior estimate of $85 million. With weekly prescriptions hovering around 20,000 and Novo Nordisk's oral Wegovy outpacing it on trajectory, the first oral non-peptide GLP-1 for obesity is generating a very different story than the hype suggested.
Regulatory Affairs
Speed Over Scrutiny? The High-Stakes Gamble Behind the NHS's New Fast-Track Drug Pilots
The UK government and the pharmaceutical industry have launched a series of pilot schemes designed to accelerate NHS patient access to innovative medicines - a direct consequence of the US-UK pharmaceutical trade arrangement that has already rewritten the terms of how Britain prices, approves, and funds new drugs. But with a BMJ analysis warning of £45 billion in diverted NHS resources and up to 229,000 excess deaths by 2036, the pilots are arriving in the middle of one of the most contested healthcare policy disputes in a generation.
Regulatory Affairs
Data Integrity and Quality Oversight: Analyzing the FDA Warning Letter for Sanofi's Waterford Site
Following a January 2026 inspection, the FDA has issued a formal warning letter to Genzyme Ireland Limited in Waterford, citing data integrity concerns, uncontrolled checklists, and quality unit oversight gaps in the manufacturing of Thymoglobulin and Altuviiio.
Regulatory Affairs
A Global Milestone for Wellness: Chanelle McCoy Health Secures Historic Dual SFDA and European Novel Food Regulatory Approvals
In a landmark world-first, Irish-founded Chanelle McCoy Health has received official regulatory approvals from the Saudi Food and Drug Authority and confirmation of safety under EU Novel Food guidelines for its Pureis® Ultra Pure CBD range.
Regulatory Affairs
The Digital and Regulatory Frontier: Top 10 Technical and GMP Trends Shaping Pharma in 2026
A comprehensive technical report detailing the top 10 trends in Good Manufacturing Practice (GMP), sterile manufacturing, GAMP 5, Quality 4.0, and continuous manufacturing currently reshaping the global pharmaceutical landscape.
Regulatory Affairs
FDA Fires Warning Shot at Sanofi's Irish Plant Over Data Cover-Up and Altuviiio Quality Failings
The FDA has issued a formal warning letter to Sanofi's Waterford facility, Genzyme Ireland Limited, citing data integrity breaches, discarded quality records, and botched deviation investigations in the production of haemophilia drug Altuviiio and transplant therapy Thymoglobulin.