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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Thailand Issued a Draft Notification on the Names of Su…
There are 3 lists of substances (plants, animals or parts of plants or animals), prohibited to be used as ingredients for 3 classes of Herba…
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EU: Amendment to the Clinical Trials Regulation (CTR) o…
The European Commission (EC) revised the current labelling requirements provided in the Clinical Trials Regulation (CTR) for investigational…
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Thailand Issues the Notification Declaring the Inflores…
This new Notification Re: Controlled Herb (Cannabis) B. E. 2565 (2022) dated 11th Nov 2022 declares the inflorescence of Cannabis (Cannabi…
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TGA – Standard for Serialization and Data Matrix …
The Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 (‘TGO 106’) comes into e…
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India Proposed Amendment to New Drugs and Clinical Tria…
The India Ministry of Health and Family Welfare (MoHFW) proposed an amendment to New Drugs and Clinical Trials (Third Amendment) Rules, 2022…
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New Vaccine to Protect People in the EU and Worldwide a…
On 13 October 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) expressed a positive op…
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