The new guideline outlines the required format and content of applications for agreement or modification of a Paediatric Investigation Plan (PIP) and requests for waivers or deferrals. It also concerns the operation of compliance checks in accordance with the Human Medicines Regulations. All paediatric submissions to the Medicines Health and Regulatory Agency’s (MHRA) should be made via the PIP section of the MHRA’s Submissions homepage. Applications should consist of some or all of the following sections, depending on the type:
• Administrative and product information
• Overall development of the medicinal product
• Application for a product-specific waiver
• Proposed Paediatric Investigation
• Request for deferral
Further details on what should be included within each section can be found in the guidance.
Applications should be based on all of the available relevant to the evaluation. This should include details of failed pharmaco-toxicological tests, clinical trials or other studies relating to the product. The amount of information available will vary depending on the specific development stage of the product. For example, if it is in early development or post authorisation, or whether it is being investigated for new or extended indications. The MHRA should be notified no later than two months in advance of a planned submission so that it can be accommodated into procedural timelines.
To view the full guidance, click here.
The MHRA have also updated section 2.2 of their guidance on submission, processing and assessment of Completed Paediatric Studies in the event of a no-deal Brexit. They have added new information to the criteria that Marketing Authorisation Holders (MAH) will need to meet if a limited evaluation of the study data is to take place.