Geography

The threat of Chinese dominance in the prescription drug sector appears to be a strong, unifying theme for legislators heading into the US Food and Drug Administration user fee reauthorization cycle, but two very different sets of policy issues must be addressed.

The acceleration of commercial health insurance was included in national development plans for 2026 released by the Chinese government in the recent “Two Sessions” policy meetings, and appears key for the next generation of innovative drugs to achieve domestic success.

China's government formally designated the biopharma sector as a newly emerging "pillar industry" in the recent “Two Sessions” meeting in Beijing, the repositioning implying it will be a high-priority industry for the next decade.

India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?

The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.

Sponsors making “big statements” with “no evidence” to back them up is one of the biggest issues faced by the UK drug regulator when it is assessing the regulatory dossiers for advanced therapy medicinal products, a quality assessor from the Medicines and Healthcare products Regulatory Agency says.

Weight loss drugs have likely proven to be the most challenging medicines to introduce to the National Health Service in England, and lessons should be learned in preparation for other game changing products.

The European Medicines Agency wants to develop a structured framework for non-clinical proof-of-concept studies in pediatric oncology.

While regulators are “catching up” to the use of artificial intelligence in clinical development, some skepticism remains around the use of AI to generate synthetic patient data, says Alexion’s Nick France.

Artificial intelligence in pharmaceutical manufacturing is increasing in prevalence, offering a unique opportunity for global regulators to align on expectations, industry group IFPMA says.

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.

Decentralized trial tools are settling into routine use as sponsors and sites apply them selectively to address protocol-specific operational needs, say Pamela Tenaerts and Kenneth Getz.

Moves to issue a compulsory license for Lilly’s GLP-1tirzepatide products Mounjaro and Zepbound come as Brazil prepares to make its own versions of Novo Nordisk’s semaglutide and liraglutide.

The Brazilian government wants to boost the country’s capabilities to develop radical innovation that leads to new therapies for the national health system.

Two major EU trade agreements are on hold, with ramifications for the pharmaceutical market.

Brazilian authorities say that some pharmaceutical companies exploit court cases brought by patients to secure drug access to achieve higher prices.

A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.

Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.

The Medicines Control Authority of Zimbabwe has begun to publish public assessment reports for medicines it approves or rejects, in line with the World Health Organization’s highest maturity level benchmarking.

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.

ImmunityBio's Patrick Soon-Shiong made several misleading efficacy claims on a podcast and TV ad about the company's cancer treatment, the FDA said in a warning letter.

The threat of Chinese dominance in the prescription drug sector appears to be a strong, unifying theme for legislators heading into the US Food and Drug Administration user fee reauthorization cycle, but two very different sets of policy issues must be addressed.

Payroll costs in the prescription drug user fee program increased in fiscal year 2025 despite the reduction-in-force and voluntary departures, which could impact industry efforts to reduce the annual charges.

The US FDA aims to prevent poor quality or incomplete responses to Form 483 inspection observations with a new draft guidance that describes the structure and content for concise, factual and effective corrective action responses.