“I don’t think Korea’s regulatory science is in the early stages. The MFDS has already been devising guidelines and evaluation methods based on science, but now it is taking it more systematically.” Korea Regulatory Science Center’s In-Sook Park on developing a more systematic approach to strengthen Korea’s regulatory framework. Find out more: KRSC Aims To Raise Korea’s Regulatory Science Game
Quotable: Top Experts On Policy Hot Topics
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
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A global collaborative inspections pilot reduced the number of individual inspections for participating manufacturing facilities, demonstrating that multiple regulatory authorities can carry out joint inspections using a mix of on-site and remote approaches.
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The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.