Drugs

Regulation and Requirements for Conducting Clinical Trials on Drug

2022-11-24
Regulation and Requirements for Conducting Clinical Trials on Drug
Guide
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Guideline on Biosimilar Products (Quality Considerations)

2017-08-22
Guideline on Biosimilar Products (Quality Considerations)
Guide
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Guideline on Blood Products (Plasma Derived Medicinal Products)

2022-11-09
Guideline on Blood Products (Plasma Derived Medicinal Products)
Guide
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Guideline on the Scientific Data Requirements for Plasma Master File (PMF)

2023-12-11
Guideline on the Scientific Data Requirements for Plasma Master File (PMF)
Guide
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The Data Requirements for Human Drugs Submission

2022-10-13
The Data Requirements for Human Drugs Submission
Guide
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Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products

2022-08-22
Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
Guide
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Data Requirements for Veterinary Medicinal Products

2022-11-06
Data Requirements for Veterinary Medicinal Products
Guide
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Good Manufacturing Practice (GMP) Guidelines

2023-01-05
Good Manufacturing Practice (GMP) Guidelines
Guide
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Top Deficiencies in Phase II Validation

2018-09-03
Top Deficiencies in Phase II Validation
Guide
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Integration Guide for DTTS

2024-08-06
Integration Guide for DTTS
Guide
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