Drugs

Data Requirements for the Renewal of Marketing Authorizations for human medicinal products

2022-06-19
Data Requirements for the Renewal of Marketing Authorizations for human medicinal products
Requirement
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Guidance for the Storage and Transport of Time- and Temperature–Sensitive Pharmaceutical Products

2019-01-08
Guidance for the Storage and Transport of Time- and Temperature–Sensitive Pharmaceutical Products
Blog
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Guidance for Submission

2022-10-19
Guidance for Submission
Guide
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Guidelines for Biowaiver

2022-01-05
Guidelines for Biowaiver
Guide
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Guideline on good pharmacovigilance practices (GVP) - Definition

2015-05-01
Guideline on good pharmacovigilance practices (GVP) - Definition
Guide
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Guideline on good pharmacovigilance practices (GVP)

2025-08-20
Guideline on good pharmacovigilance practices (GVP)
Guide
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GCC Module 1 Specifications

2015-04-11
GCC Module 1 Specifications
Requirement
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Guidelines for Bioequivalence

2024-05-21
Guidelines for Bioequivalence
Guide
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Baseline eCTDSubmission Requirement

2016-06-26
Baseline eCTDSubmission Requirement
Guide
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Guidance for the Preparation of a Site Master File (SMF)

2022-11-09
Guidance for the Preparation of a Site Master File (SMF)
Guide
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