Get the free Guidance on paediatric submissions

17 October 2018 EMA/672643/2017 Rev.1 Human Medicines Research and Development Support DivisionGuidance on pediatric submissions' submission Gateway and submission web clientele of Contents 1. Introduction

How to fill out guidance on paediatric submissions

How to fill out guidance on paediatric submissions

1. Start by gathering all the necessary information and documentation related to the paediatric submission.
2. Follow the specific guidelines provided by the regulatory authorities for filling out the guidance on paediatric submissions.
3. Begin by providing a clear and concise summary of the paediatric development plan, including the objectives, timeline, and proposed studies.
4. Describe the proposed age groups and the rationale behind the chosen age range for the paediatric population.
5. Present the available data on the safety, efficacy, and pharmacokinetics of the drug in the paediatric population.
6. Include a detailed description of the proposed study design, endpoints, and statistical analysis plan for any planned clinical trials.
7. Specify any ethical considerations and measures taken to ensure the welfare of paediatric patients during the study.
8. Provide information on any pediatric formulations or dosage forms available or planned for the drug.
9. Detail any plans for post-authorization studies, pediatric pharmacovigilance, and long-term follow-up for safety monitoring.
10. Review and revise the guidance document multiple times to ensure clarity, accuracy, and compliance with regulatory requirements.
11. Submit the filled-out guidance on paediatric submissions to the appropriate regulatory authority for approval.

Who needs guidance on paediatric submissions?

1. Pharmaceutical companies conducting clinical trials involving paediatric populations
2. Researchers and scientists involved in paediatric drug development
3. Regulatory authorities responsible for evaluating and approving paediatric submissions
4. Healthcare professionals prescribing medications to paediatric patients
5. Patients and their families seeking information about paediatric drug treatments

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What is guidance on paediatric submissions?

Guidance on paediatric submissions provides instructions and recommendations for submitting pediatric data to regulatory authorities.

Who is required to file guidance on paediatric submissions?

Companies developing drugs for pediatric populations are required to file guidance on paediatric submissions.

How to fill out guidance on paediatric submissions?

Guidance on paediatric submissions can be filled out by following the specific instructions provided by regulatory authorities.

What is the purpose of guidance on paediatric submissions?

The purpose of guidance on paediatric submissions is to ensure that pediatric data is submitted in a consistent and appropriate manner for regulatory review.

What information must be reported on guidance on paediatric submissions?

Information such as study designs, endpoints, and ethical considerations related to pediatric studies must be reported on guidance on paediatric submissions.