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Asia Pacific

Set Alert for Asia Pacific

Korea Should Pursue Two-Pronged Strategy In Global Vaccine Hub Bid

South Korea is making a strategic push to strengthen its vaccine capabilities, with a focus on COVID-19 and future pandemics and the aim of becoming a global development hub. But one expert told a recent meeting that these goals should not overshadow the government’s original aim of becoming self-sufficient for the national immunization program.

South Korea Vaccines

Stringent Regulations Hinder International Trials In China: Trade Groups

Any delays caused by unpredictable regulatory reviews related to the export of genetic materials threaten to derail the inclusion of China in international clinical trials, caution two trade groups representing the pharma industry in the country.

China Clinical Trials

Ready, Set, Go: China To Use Patient-Reported Outcomes In Clinical Studies

As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.

China Real-World Evidence

GMP Deficiencies Lead Brazil To Target Sinovac’s Chinese COVID-19 Vaccine Plant

Having decided to suspend 12 million doses of Sinovac’s coronavirus vaccine, Brazil’s regulatory agency says it will need to make its own on-site assessment of conditions at the Chinese facility that makes the product.

China Brazil

Project Orbis Nears 30 Approvals In Oncology; Could China Be Added?

A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.

Review Pathway Cancer

Australian Industry Signs Deal To Fund Access To Innovative New Drugs

Hot on the heels of Australia’s plan to overhaul the National Medicines Policy comes a new deal with the pharmaceutical industry to make new drugs available as soon as possible after approval and get patients more closely involved in reimbursement processes.

Australia Market Access

Global Pharma Guidance Tracker – August 2021

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.

Guidance Documents Regulation

Australia To Address Supply Chain Issues In Medicines Access Review

Stakeholders are being asked to say what they think of plans to future-proof the framework that governs access to medicines and is intended to help bolster the pharmaceutical sector.

Australia Market Access

Coronavirus Notebook: New Deal To Boost Local Vaccine Manufacturing, EU Warns Of RoActemra Shortages

MSF tells G20 leaders to “put your money where your mouth is” on vaccine sharing, the UK is considering whether to vaccinate all 12-15-year olds, and the UK & Australia are to swap excess vaccines.

Asia Pacific Australia

After Zydus' Historic COVID-19 DNA Vaccine Approval, Inovio To Enter Phase III

Soon after Zydus Cadila won a historic accelerated approval in India for the world’s first plasmid DNA vaccine for human use, in this case against COVID-19, Inovio’s candidate is set to move to Phase III in Brazil. But will the new technology find wide acceptance?

Approvals Coronavirus COVID-19

Malaysia Swaps On-Site GMP Checks For Virtual Inspections At Foreign Sites

The COVID-19 pandemic has driven the Malaysian National Pharmaceutical Regulatory Agency to explore new mechanisms to oversee compliance with good manufacturing practice requirements at foreign and domestic sites. 

Manufacturing Malaysia

Malaysia, Singapore Join Hands On Review Of Generic Drugs

The National Pharmaceutical Regulatory Agency and the Health Sciences Authority have announced a pilot to kick-off their new initiative on the simultaneous assessment of new generic drugs.

Malaysia Singapore
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