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