The Medicines and Healthcare products Regulatory Agency (MHRA) has established comprehensive guidelines detailing the "Format and content of applications for agreement or modification of a Paediatric Investigation Plan (PIPs)" in the United Kingdom. These guidelines also cover procedures for requesting waivers, deferrals, and the operational aspects of compliance checks, all by the Human Medicines Regulations (HMRs) 2012, as amended.
Paediatric Investigation Plans (PIPs) are crucial documents that outline the strategy for investigating the safety and efficacy of medicinal products in children. These plans are essential for ensuring that new medicines are safe and effective for pediatric populations.
Format and Content of PIP Applications
Applications for PIPs in the UK must adhere to a specific format and content. This includes several key sections:
Part A: Administrative and Product Information: This section provides essential details about the applicant and the medicinal product, including its name, active ingredients, and intended use.
Part B: Overall Development of the Medicinal Product: This part covers the development history of the product, including any relevant adult or pediatric studies conducted.
Part C: Application for a Product-Specific Waiver: This section outlines why certain pediatric studies may not be necessary or feasible if applicable.
Part D: Proposed Paediatric Investigation Plan: This is the application's core, detailing the specific studies and measures planned to assess the product's safety and efficacy in children.
Part E: Request for Deferral: If needed, this section explains why certain studies cannot be completed within the usual timeframe.
Part F: Annexes: Additional supporting documents, such as study protocols and literature reviews, are included here
These components ensure that the PIP comprehensively addresses all aspects of paediatric development for the medicinal product.
Submission Process
Applicants must submit their PIP applications through the MHRA's online portal. The MHRA assesses these plans to ensure they meet regulatory requirements and provide adequate information to support the safe use of the medicinal product in children. In certain circumstances, it may not be necessary or feasible to conduct studies in all paediatric populations. Applicants can request:
Waivers: Exemptions from the requirement to conduct studies in specific paediatric groups, justified by factors such as the disease not affecting certain age groups or safety concerns.
Deferrals: These are Permissions to delay paediatric studies until after initial marketing authorization, allowing for the collection of additional data before including paediatric populations.
Proper justification and detailed plans must support these requests to ensure they are scientifically sound and ethically appropriate.
Before a marketing authorization application is submitted, the MHRA conducts a compliance check to verify that all agreed-upon measures in the PIP have been adhered to. This process ensures that paediatric studies are conducted as planned and that their results are incorporated into the product's assessment.
Applicants are required to submit annual reports detailing the progress of ongoing paediatric studies. Additionally, any significant changes, discontinuations, or suspensions of paediatric developments must be promptly communicated to the MHRA.
For comprehensive guidance and access to relevant forms and submission portals, applicants should refer to the official MHRA documentation. gov.uk
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