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Pharma and Biotech
NPRA published Guidance Document and Guidelines for Registration of Biosimi…
The NPRA has released a revised edition of the biosimilar product registration guidelines in the...
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Pharma and Biotech
HSA Singapore: 4 Products Found to Contain Potent or Banned Ingredients
Health Sciences Authority (HSA) of Singapore has issued a public alert regarding four products sold...
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Pharma and Biotech
Seizure Of Over $2 Million Worth Of Illegal Medicine Imports
In a joint effort, the Therapeutic Goods Administration (TGA) and Australian Border Force (ABF) successfully...
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Pharma and Biotech
US FDA Releases Draft Guidance on Translation for Good Laboratory Practice …
This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in...
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Pharma and Biotech
ANVISA updated procedures for imports of medicines including herbal medicin…
ANVISA has updated its import authorization procedures for medicines and substances subject to special control....
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Pharma and Biotech
Argentina ANMAT proposes guidelines for decentralized clinical trials
Argentina ANMAT guide outlines the requirements for decentralized elements in clinical pharmacology studies, including roles...
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Pharma and Biotech
Malaysia Decentralised Clinical Trial (DCT) Guidance Document
Malaysia has released its first Decentralised Clinical Trial guidance document, which provides detailed guidance on...
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Pharma and Biotech
MFDS Proposed Partial Revision of Regulations on the Safety of Pharmaceutic…
Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision to Regulations on...
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Pharma and Biotech
US FDA Provides Recommendations on the Statutory Prohibition on Wholesaling…
According to FDA, this draft guidance describes the FDA’s interpretation of, and policies concerning, the...
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Pharma and Biotech
Thailand Proposes Standards Regarding the Supervision of Herbal Products Co…
The Thailand Ministry of Public Health proposes draft standards regarding the Supervision of Herbal Products...
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