- D 1 Orphan Medicinal Products / Orphan Drugs
- D 1.1 General Information about Orphan Medicinal Products
- D 1.2 Application for Designation as Orphan Medicinal Product (Orphan Drug Designation)
- D 1.2.1 Common EMA/FDA Application for Orphan Designation for Medicines
- D 1.3 Marketing Authorisation Application for Orphan Medicinal Products
- D 1.4 Market Exclusivity and Exemptions from Market Exclusivity for an Orphan Medicinal Product
- D 2 Paediatric Medicines
- D 2.1 Introduction
- D 2.2 Historical Overview
- D 2.2.1 The EMA Paediatric Working Party
- D 2.2.2 The Task-Force in Europe for Drug Development for the Young (TEDDY)
- D 2.2.3 The Legislative Process
- D 2.3 Regulation 1901/2006/EC as amended
- D 2.3.1 Key Items of the Regulation
- D 2.3.2 The Paediatric Committee (PDCO)
- D 2.3.3 Paediatric Investigation Plan (PIP), Waiver and Deferral
- D 2.3.4 Incentives and Rewards
- D 2.3.5 Measures for the Improvement of Data and Information
- D 3 Advanced Therapy Medicinal Products
- D 3.1 What are Advanced Therapy Medicinal Products - Definition
- D 3.2 Key Items of the Advanced Therapies Regulation
- D 3.3 Advanced Therapy Medicinal Products - Specific Requirements
- D 3.3.1 ATMPs - Specific Requirements for the Product Information
- D 3.3.2 Specific Post-authorisation Requirements
- D 3.4 ATMPs - Incentives for Applicant and Holder of a Marketing Authorisation
- D 3.5 Committee for Advanced Therapies (CAT)
- D 3.6 Advanced Therapies Regulation - A Lex Specialis
- D 3.6.1 Implementation of the Advanced Therapies' Regulation
- D 3.7 ATMPs - Dossier Requirements in Directive 2009/120/EC
- D 3.8 Advanced Therapies´ Regulation - Where to find further Information
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