UK MHRA Guidance: 150-Day Assessment for National Applications for Medicines & Procedures for UK Paediatric Investigation Plans (PIPs)

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) continues to innovate in the regulatory space with updated processes designed to enhance efficiency and address specific healthcare needs. Two critical pathways, the 150-Day Assessment for National Applications for Medicines and the Procedures for UK Paediatric Investigation Plans (PIPs), reflect the MHRA's commitment to fostering faster access to medicines while prioritizing paediatric healthcare.

Guidance: 150-Day Assessment for National Applications for Medicines

The 150-day assessment process is designed to support innovative and generic medicines seeking marketing authorisation in the UK. This pathway aligns with MHRA’s commitment to faster access to medicines while ensuring regulatory rigour. Specific eligibility criteria must be met, and applicants are advised to confirm their product’s suitability before submission.

Applications must be submitted via the MHRA Submission Portal. Comprehensive dossiers in eCTD format are required, demonstrating compliance with UK regulatory requirements. Fees for the 150-day assessment are competitive and vary based on the complexity of the application. Applicants should refer to the MHRA’s fee structure for specifics. MHRA performs an initial submission validation to ensure all required documents are present. The validation period typically lasts 14 days, after which the assessment begins.

The assessment involves two key phases: the initial review and the applicant's response to questions. The process ensures that safety, efficacy, and quality standards are rigorously evaluated within the accelerated timeframe. For more details, refer to the official guidance here.

Guidance: Procedures for UK Paediatric Investigation Plans (PIPs)

Paediatric Investigation Plans (PIPs) are vital in ensuring that medicines are developed for use in children. The MHRA has released updated guidance outlining the procedures for PIPs in the UK, incorporating the Windsor Framework and addressing unmet needs in paediatric healthcare. The guidance provides a structured approach to developing, modifying, and obtaining waivers for PIPs in the UK.

Medicines marketed in Northern Ireland must comply with EU paediatric regulations under the Windsor Framework. This requires dual consideration for applications targeting both Great Britain and Northern Ireland. PIP Submissions must include comprehensive data on the safety, efficacy, and quality of the medicine in the paediatric population. PIPs should be submitted as standalone applications or as part of a marketing authorisation dossier.

A waiver can be sought if the medicine is unlikely to benefit children or if it targets a condition not present in the paediatric population. The guidance emphasises addressing unmet paediatric needs, particularly in areas with limited or non-existent therapeutic options. Category 2 products (e.g., biosimilars) must meet additional requirements to ensure their suitability for paediatric use.

For more details, refer to the official guidance here.