EMA GVP Product or Population Specific Considerations IV

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations IV: Paediatric population

P.IV.A. Introduction:

The paediatric population is defined in the European Union (EU) as that group of the population between birth and 18 years of age. The paediatric population encompasses several subsets. In accordance with current guidelines1,2, the applied age classification of paediatric patients is:

• preterm newborn neonates: from day of birth through the expected date of delivery plus 27 days;

• term and post-term neonates: from day of birth plus 27 days;

• infants (or toddlers): from 1 month (28 days) to 23 months;

• children: from 2 years to 11 years; and

• adolescents: from 12 years to less than 18 years.

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Table of contents

P.IV.A. Introduction

P.IV.A.1. Pharmacovigilance aspects specific to the paediatric population

P.IV.A.1.1. Susceptibility to adverse reactions

P.IV.A.1.2. Limited numbers of subjects in paediatric clinical trials

P.IV.A.1.3. Medication errors

P.IV.A.1.4. Off-label use

P.IV.A.1.5. Clinical presentation of adverse reactions

P.IV.B. Structures and processes

P.IV.B.1. Risk management plan (RMP) 

P.IV.B.2. Management and reporting of adverse reactions

P.IV.B.2.1. Age information

P.IV.B.2.2. Other information relevant to the paediatric population

P.IV.B.3. Periodic safety update report (PSUR) 

P.IV.B.4. Post-authorisation safety studies (PASS)

P.IV.B.5. Signal management

P.IV.B.6. Safety communication

P.IV.C Operation of the EU network

P.IV.C.1. Roles and responsibilities

P.IV.C.1.1. Marketing authorisation holder and applicant in the EU

P.IV.C.1.2. European Medicines Agency

P.IV.C.1.2.1. The Paediatric Committee (PDCO)

P.IV.C.1.2.2. Interaction between the PDCO and the Pharmacovigilance Risk Assessment Committee (PRAC)

P.IV.C.2. The paediatric investigation plan in the EU (PIP)

P.IV.C.3. The risk management plan in the EU

P.IV.C.4. The periodic update safety report in the EU

P.IV.C.5. Designing a post-authorisation safety study and protocol submission in the EU

P.IV.C.6. Signal management within the EU regulatory network

P.IV.C.7. Safety communication in the EU

EMA GVP Product or Population Specific Considerations IV: