Geography

Several global products have been granted approval recommendations in Japan, while two Japan-originated drugs received a preliminary nod in their home country after being approved first elsewhere through licensees.

South Korea has laid out comprehensive drug pricing reforms that aim to enhance patient access to treatment, accelerate innovation and stabilize essential drug supplies, but the industry is concerned it could lead to weaker R&D and manufacturing and increased dependency on high-priced imports.

Among products granted conditional approval in China over the 2020-22 period, the completion of confirmatory trials and conversion to traditional approval took up to a median of five years, according to a Pink Sheet analysis.

While Japan tries to balance its healthcare costs, the major US industry group is concerned reimbursement pricing practices in the country could influence US levels under Trump's MFN policy.

Changes to the procurement of critical medicines and their active ingredients are among the amendments the Council of the EU has made to the draft Critical Medicines Act.

The Association of the British Pharmaceutical Industry said 2024 marks the fourth consecutive year of declining patient recruitment in UK industry trials, calling it the most concerning trend despite a surge in trial initiations.

New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.

Portugal has made permanent a pilot aimed at cutting review timelines for certain clinical trial applications.

New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.

Postmarket optimization studies for cancer drugs can strengthen clinical trust in cancer medicines, which in turn results in therapies being used more often, a researcher says.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Incentives are “probably the only solution” to encouraging companies to optimize cancer drugs, but this will require funding and systemic changes, the chair of the European Medicines Agency’s oncology working party says.

Argentina’s medicines regulator, ANMAT, is updating the national pharmacopeia with new guidelines on advanced therapies.

Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

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.

At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.

CMS backs off on a plan to put “guardrails” around manufacturer payments that are excluded from Average Sales Price calculations in Medicare, but is planning to revisit the issue.

The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.