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China Grants First mRNA COVID Vaccine Approval To Homegrown Latecomer
CSPC Pharmaceutical's SYS6006 has gained an emergency use authorization in China less than one year after entering clinical trials, becoming the first mRNA vaccine for COVID-19 to be approved in the country.
Australia To Seek Stakeholder Input On Terms Of HTA Review
The review of the health technology assessment system will look at the use of adaptable and flexible approaches to managing future health care technologies, early and equitable access for patients, as well as the possibility of international work-sharing initiatives and comparisons of purchasing practices.
Japan Price Revision: Mixture of Cuts And Increases Amid Supply Crisis
Japan’s annual drug reimbursement price revision for 2023 will cut approximately $2.3bn from national healthcare costs, and while several temporary price increases have been granted to cope with an ongoing supply crisis for some products, a system of one-off revisions for big sellers remains.
Amid US Cough Syrup Findings, Regulators Feel India Needs To Work On Perceptions But Also Make Improvements
In wake of the furore caused by OTC cough syrups made by two small Indian companies, former and current US FDA and MHRA officials say quality-related issues are not specific to India. However, while image management needs some work, manufacturers in the country also need to make further improvements to ensure quality.
China’s CDE Explains Major Issues Around Conditional Approval Scheme
China's conditional approval system, which is an accelerated pathway, is being increasingly used by pharma firms, but some thorny issues remain such as the impact on full approvals, the scheme’s relation to priority reviews and currently available therapies and deadlines for confirmatory studies. Staff from the country's Center for Drug Evaluation discussed various topics around the system in a recent article.
Korea’s Biopharma Regulatory Reform Push To Focus On Innovation, Streamlining
South Korea is aiming to implement a broad range of regulatory reform steps to better compete with global rivals and speed up patient access to novel therapies.
China New Government Policies Taking Shape As Two Sessions Underway
Moderate growth goal and lingering impact from COVID policies dampen prospects of a quick recovery for China.
Feedback Sought On Proposals To Improve Australia’s Recall Processes
The deadline is nearing for comments on changes the Therapeutic Goods Administration has proposed making to its therapeutic products recall processes.
Global Pharma Guidance Tracker – February 2023
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.
China Business Pessimism Grows Amid COVID Origin Assessment, Congressional Hearing
Simmering US-China tensions dash hopes that a recent border reopening will put many collaborations back on track, even as more than half foreign businesses now downgrade the importance of investing in China.
China's Gene-Editing Baby Scientist Stirs Up Rare Disease Controversy
Jiankui He, the researcher behind China's world-shocking gene-edited babies scandal, now leaps into rare diseases research area but ethics oversight remain murky.
Go Global Or Stay Home? Geopolitics, Funding Crunch May Force China Biotechs To Choose
Having been used to navigating the Pacific with few obstacles, biotech companies taking advantage of Chinese resources and US innovation now face ballooning tensions between the two countries, which along with narrowing funding channels will increasingly force them to decide where to place their bets in the world’s largest economies.
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