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Last updated 7 days ago
7 days ago
Reflection paper on the pharmaceutical development of medicines for use in the...
16 days ago
Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous...
Draft guideline on core SmPC for human normal immunoglobulin for intravenous administration...
21 days ago
Questions and answers on Data Monitoring Committees issues
about 1 month ago
Guideline on registry-based studies
3 months ago
Guideline on the quality of water for pharmaceutical use
4 months ago
Questions and answers - ICH guideline M7 on assessment and control of...
ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities...
Draft 2 Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance
CVMP strategy on antimicrobials 2021-2025
Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I –...
5 months ago
Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance
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