China’s State Council has released a wide-ranging set of policy incentives intended to eliminate regulatory barriers and improve market access for innovative drugs.
2024 saw important regulatory changes in India including in areas such as GMP, clinical trials and efforts to rein in unethical marketing practices. Further action is expected to play out in the new year as well.
Major foreign pharma industry groups in Japan are threatening to pull out of a planned public-private council initiative over a proposed sales tax on certain drugs to fund drug discovery.
The policies for China’s biopharma industry in 2024 centered around innovative small molecules, biologics and cell and gene therapies. Regulation changes for the industry in 2025 could be a continuation of that.
Multiple industry groups in Japan warn that a decision to implement an "off-year" drug price revision in April will reverse other recent policy moves to support innovation.
The Pink Sheet looks at what major policies and regulations South Korean authorities prioritized in 2024 and what may be in store for this year.
China has granted its first approval for a stem cell therapy, to domestic firm Platinum Life Biotech’s umbilical cord-derived mesenchymal stem cell product for corticosteroid-failed acute graft-versus-host disease with gut involvement.
Speedier approval of clinical trials, flexibility towards new technologies, faster access to new drugs and lingering regulatory barriers to decentralized trials are among the challenges South Korea is facing in becoming a global trial hot spot.
China is advocating reforms to health insurance, particularly the wider use of commercial schemes, for reasons to support innovative drug development.
A shifting political power balance in Japan is leading to renewed debate on the pace of regular drug reimbursement price cuts.
Formal full official approvals for both products expected by early January, which would in both cases be the first to be granted worldwide.
A short-lived but shocking attempt to declare martial law by South Korea's president has thrown the country into political turmoil which could disrupt foreign biopharma investment and key policy initiatives.
The majority of new drugs added to the latest revision of China's NRDL were developed by Chinese companies, although half of the global top 20 pharmas also have new entries. Bispecifics were included for the first time but no CAR-Ts made the cut.
A new batch of positive approval recommendations in Japan includes an ALS drug requested by a local patient group.
India continues to reform biopharma regulatory processes and widen digitization efforts. The regulator will curb "re-deliberations" at subject expert committee meetings unless applicants furnish new data.
US President-elect Donald Trump’s second term is seen in general as “bad news” for Asia, especially China, by some analysts. But the outlook for India pharma appears upbeat, says a cross-section of experts.
A new drug-hunting initiative funded by the Chinese government will focus on novel therapies for chronic diseases and encourage academia-industry collaboration.
The head of the Korea Regulatory Science Center talks exclusively to the Pink Sheet about why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.
Asia-Pacific continues to solidify its position as a key location for clinical trials, with China in particular dominating such activity in the region, and increasingly globally, a new Citeline White Paper shows.
While Japan awarded relatively high premiums to several products newly listed for reimbursement, others were the subject of prolonged debate or are facing imminent cost-effectiveness assessment.