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.
India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.
The message that the US may lose its lead in biotech to China appears to have bipartisan resonance on Capitol Hill. That sets a favorable context for the kickoff of the next user fee reauthorization process.
China’s NHSA expects to release the first list of innovative drugs to be covered by commercial health insurance in early December, but implementation, payment collection and data sharing are expected to be among the main hurdles ahead.
Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds
A new 10-year, government-supported R&D program in China will focus on new targets and emerging technologies which can be translated into first-in-class drugs and give birth to top players in the global pharma industry.
Excellence, innovation and deal-making across the Japanese biopharma sector were celebrated at the Citeline Japan Awards 2025, held in Tokyo on 21 October.
Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.
China's NMPA announces new measures designed to speed up access to imported medicines already launched abroad ahead of their final formal regulatory approval in China.
The Health Sciences Authority wants drug companies to familiarize themselves with its electronic common technical document platform before it goes live next year.
India rolls out amended R&D financial assistance plan targeting certain ‘priority areas’ and calls for proposals from industry and startups. While the corpus is modest, the scheme hopes to enable the ‘Innovate in India’ ecosystem and includes a co-funding provision.
After tough negotiations which won the country a lower US levy on pharmaceuticals, there still appears to be some confusion within the Japanese government following President Trump's latest announcement on global pharma tariffs.
As US Secretary of State Marco Rubio hints at reconsideration of a punitive Russian oil tariff, Trump adds an H-1B visa brick to his trade wall and India lowers GST on cancer and rare disease drugs, the Pink Sheet considers the impact.
China’s new 30-day pathway for IND review and approval is designed to speed up the entry of qualified innovative medicines into clinical trials, but multiple eligibility criteria apply.
Hong Kong is pushing forward with its vision to build an “internationally renowned” regulatory authority of drugs and medical devices. Meanwhile, the Department of Health’s 1+ drug registration mechanism has received over 620 enquiries from over 160 pharmaceutical companies.
Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!
Japan's government has already allocated more than $400m to repatriate manufacturing of important drugs and continues to provide support as it expands a list of "national security" drugs.