All March 2024 articles
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JournalCan the Japanese phase I study be waived?
New guidance: ‘Basic principles for conducting phase I studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan,’ issued in December 2023
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JournalNew data protection for maximum residue limits
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract Maximum residue limits (MRL) have been a requirement for all substances included in veterinary medicines intended for food-producing animals since the 1990s. The new Veterinary Medicines Regulation ([EU] 2019/6) ...
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JournalClinical trial design – keeping up with innovation
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract A well-designed clinical trial is essential for the collection of reliable, robust and meaningful data to ensure the protection of participants rights and safety and also minimise economic losses ...
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EditorialDiverse and dynamic regulation in the Asia Pacific region
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Our first regionally focused issue for 2024 metaphorically travels to the Asia-Pacific (APAC) region. Asia makes up 60% of the global population and there are a large number of regulatory ...
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JournalNavigating the regulatory terrain down under: trends in Australia for 2024
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Introduction Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the ...
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