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Asia Pacific

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China Turns To New Vaccines As It Eases 'COVID Zero' Restrictions

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.

China Coronavirus COVID-19

Japan’s Drug Distribution Crisis: Pharma Urges Govt To Reform Pricing System

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.

Japan Distribution

Japan Discuss Faster AI Processing For Healthcare Sector

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.

Japan Artificial Intelligence

Lunsumio Provides First Test For Korea's Breakthrough Therapy Program

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.

South Korea Innovation

Pakistan Proposes Risk-Based Inspections Approach ‘Capable Of Revealing Weaknesses’

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.

Pakistan Manufacturing

Australia Moves Closer To Reducing HTA Discount Rate For First Time In Decades

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.

Health Technology Assessment Australia

China & Pakistan Turning To Electronic Platforms For Smoother Export, Import Certification

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.

China Pakistan

The Quality Lowdown: US FDA Warning Letters, 483 Reports Hit Poor Sterility And Lax Investigations

Bristol-Myers Squibb’s Abraxis Unit, Nephron and Lupin hit with warning letters; Lupin and Jubilant 483 inspection reports posted.

Manufacturing Quality

Australia Seeks Views On Plans To Drop Dual Drug Substance Names

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.

Australia Ingredients

Biden-Xi Bali Meet Reopens US-China Cooperation, Looks Positive For Health Players

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.

Politics Strategy

China CDE Stresses Need For Pre-Trial Consultations

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.

China Clinical Trials

Will RWD Get Real In Japan? Govt Moves To Build Digital Health Records

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.

Japan Real-World Evidence
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