Pháp chế

Hồ sơ đăng ký, tuân thủ pháp lý và hướng dẫn cơ quan quản lý.

ANDA Submission — Key Components and Common Deficiencies

What an ANDA submission needs to include, and the deficiencies FDA cites most often.

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.

EU Marketing Authorization — Centralized vs National Procedure

How the centralized, decentralized, and mutual recognition procedures differ for EU marketing authorization.

GMP Inspection Readiness — Common FDA 483 Observations

The most common categories of FDA 483 observations and how facilities prepare to avoid them.

ICH Common Technical Document (CTD) — Module Structure Overview

How the five CTD modules are organized and what each is expected to contain.

Orphan Drug Designation — Regulatory Pathway Overview

What orphan drug designation requires and the incentives it provides during development.

Pharmacovigilance Requirements — Post-Marketing Safety Reporting Overview

Core post-marketing safety reporting obligations once a product is on the market.

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.

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.

WHO Prequalification — Requirements for API Manufacturers

What API manufacturers need to demonstrate to achieve WHO Prequalification status.