인허가
인허가 신청, 컴플라이언스 및 규제기관 가이드라인.
인허가
2026년 8월 25일
ANDA Submission — Key Components and Common Deficiencies
What an ANDA submission needs to include, and the deficiencies FDA cites most often.
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인허가
2026년 8월 25일
Drug Master File (DMF) — Purpose and Submission Requirements
What a Drug Master File is for and what an API manufacturer needs to include when filing one.
인허가
2026년 8월 25일
EU Marketing Authorization — Centralized vs National Procedure
How the centralized, decentralized, and mutual recognition procedures differ for EU marketing authorization.
인허가
2026년 8월 25일
GMP Inspection Readiness — Common FDA 483 Observations
The most common categories of FDA 483 observations and how facilities prepare to avoid them.
인허가
2026년 8월 25일
ICH Common Technical Document (CTD) — Module Structure Overview
How the five CTD modules are organized and what each is expected to contain.
인허가
2026년 8월 25일
Orphan Drug Designation — Regulatory Pathway Overview
What orphan drug designation requires and the incentives it provides during development.
인허가
2026년 8월 25일
Pharmacovigilance Requirements — Post-Marketing Safety Reporting Overview
Core post-marketing safety reporting obligations once a product is on the market.
인허가
2026년 8월 25일
Post-Approval Changes: FDA Reporting Categories (PAS, CBE-30, CBE-0, Annual Report)
How FDA classifies post-approval manufacturing changes under 21 CFR 314.70, and what reporting each category requires.
인허가
2026년 8월 25일
Regulatory Labeling Requirements — SmPC and Package Insert Content
What must appear in a Summary of Product Characteristics and package insert, and how they differ by region.
인허가
2026년 8월 25일
WHO Prequalification — Requirements for API Manufacturers
What API manufacturers need to demonstrate to achieve WHO Prequalification status.
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