Argentina ANMAT proposes guidelines for decentralized c…
Argentina ANMAT guide outlines the requirements for decentralized elements in clinical pharmacology studies, including roles and responsibil…
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Malaysia Decentralised Clinical Trial (DCT) Guidance Do…
Malaysia has released its first Decentralised Clinical Trial guidance document, which provides detailed guidance on implementing decentralis…
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MFDS Proposed Partial Revision of Regulations on the Sa…
Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision to Regulations on the Safety of Pharmaceuticals through Safety Not…
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US FDA Provides Recommendations on the Statutory Prohib…
According to FDA, this draft guidance describes the FDA’s interpretation of, and policies concerning, the prohibition on wholesaling i…
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Thailand Proposes Standards Regarding the Supervision o…
The Thailand Ministry of Public Health proposes draft standards regarding the Supervision of Herbal Products containing cannabis/hemp flower…
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Thailand Published the Criteria, Methods and Conditions…
The Thailand Ministry of Public Health published the benefits of promoting, supporting, and developing effective drug research studies, incl…
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TGA Introduced Changes Applying to Evaluation of New Su…
The TGA has introduced changes regarding the evaluation of new ingredients to be used in Listed (AUST L) and Listed Assessed (AUST L (A)) me…
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Taiwan FDA published Guidelines for the Implementation …
Real-world evidence is the latest international clinical application trend, which can be used to improve the design of clinical trials, and…
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Thai FDA Issued Criteria, Methods and Conditions for Sa…
The Thai Food and Drug Administration (TFDA) Issued Criteria, methods, and conditions for the sampling of herbal products manufactured or im…
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EU Recommendations to Facilitate the Conduct of Decentr…
The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have published recommendations …
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