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In a significant policy shift and following recent public unrest, China now appears to be moving away from its strict "COVID Zero" restrictions to salvage a floundering economy hard hit by repeated lockdowns, as part of which it is looking to accelerate the approval of new vaccines and increase vaccination rates in the elderly.
The impact of drug shortages in Japan, including of essential products, is being considered as part of government-level discussions to consider the appropriateness of the current reimbursement pricing system. Amid rising production costs and wider global challenges, some experts in the industry are now asking for price increases.
As Japan's PMDA reopens discussions on the appropriate regulation of AI in healthcare, a process which has so far focused on diagnostic technologies, some committee members point out the need for a more flexible approach.
South Korea's breakthrough therapy system, Global Innovative Products Fast Track, kicks off with Roche’s follicular lymphoma drug becoming the first to test the new system. Meanwhile, a state-run group is linking with pharma firms to rapidly bring in global new drugs.
Regulators in Pakistan are consulting on draft rules that outline their plan to introduce a risk management approach to their inspection activities and the frequency at which manufacturers can expect to undergo an inspection.
The pharmaceutical industry body Medicines Australia has welcomed an advisory committee’s recommendation on reducing the 5% discount rate that has been used in health technology assessments for 30 years, although it would have liked to see a bigger reduction and to have it implemented more quickly.
Drug export enterprises will be able to use electronic certificates in China from December. Meanwhile, efforts are under way in Pakistan to make it possible for companies to use an integrated electronic platform for importing and exporting raw materials and finished products using a single entry point.
Bristol-Myers Squibb’s Abraxis Unit, Nephron and Lupin hit with warning letters; Lupin and Jubilant 483 inspection reports posted.
Dozens of pharmaceutical ingredients have two different names in Australia, which can be a source of confusion. The country’s regulator is planning to require such substances to have a single name from next April, although this could be deferred for certain ingredients if stakeholders feel it is warranted.
A meeting between the heads of the world's two largest economies potentially opens the door for health cooperation, a rare positive sign amid worsening economic decoupling, accelerating diversification away from China and the need for multinationals to modify localization strategy.
China's Center for Drug Evaluation has published proposed guidelines on the review process for clinical trial protocols, in which it stresses the importance of discussing these ahead of the start of pivotal trials.
To enable broader use of clinical data in its digital health care system, Japan has kickstarted digitization measures to link all patient records to an online individual ID system. While the government aims to allow real-world data and evidence for the pharmaceutical sector in the long run, The Pink Sheet explores the reality of current projects and measures in the country.
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