UK Guidance: How to apply for Medicines: Integrated Scientific Advice (ISA)

Developing innovative medicines requires early, structured engagement with regulators. The UK’s Integrated Scientific Advice (ISA) service provides coordinated, multidisciplinary guidance to help applicants generate robust evidence and navigate regulatory requirements efficiently.

What is Integrated Scientific Advice (ISA)?

Integrated Scientific Advice (ISA) is a coordinated regulatory advice service that brings together expertise from across the UK regulatory landscape. It is designed to provide applicants with comprehensive, joined-up scientific and regulatory advice during medicine development.

Integrated Scientific Advice supports medicine developers by clarifying regulatory requirements, aligning development strategies with UK standards, and addressing scientific uncertainties early in the product lifecycle.

The service is particularly valuable for innovative medicines, complex technologies, and novel clinical development programmes where coordinated advice across quality, non-clinical, clinical, and regulatory domains is essential.

Writing Good Questions for Integrated Scientific Advice (ISA)

The quality of the advice received through ISA depends significantly on the clarity and precision of the questions submitted by the applicant. Questions should be clearly written, concise, and focused on specific issues. Each question should address a single topic and provide sufficient background information to enable assessors to understand the context fully.

Applicants are expected to present their proposed approach and supporting rationale when asking a question. This ensures that regulators can provide meaningful and targeted feedback rather than general guidance.

Creating an ISA Briefing Book

The ISA briefing book is a structured document submitted in advance of the advice meeting. It provides the scientific, technical, and regulatory background necessary for regulators to evaluate the questions raised. A well-prepared briefing book is essential because it forms the foundation for both the meeting discussion and the final ISA report.

The briefing book typically includes a product overview, a summary of regulatory history, and detailed sections covering quality (Chemistry, Manufacturing and Controls), non-clinical development, and clinical development. It should also clearly outline the applicant’s development strategy and list the specific questions for which advice is being sought.

Fees for the ISA Service

Integrated Scientific Advice is a fee-based service. The fees depend on the scope and complexity of the request, the number of scientific disciplines involved, and the type of product under development. Applicants should ensure that payment arrangements are completed in accordance with the published guidance to avoid administrative delays in processing their request.

Getting the Most from Your ISA Meeting

During the meeting, discussions should remain focused on the agreed questions and key scientific issues. Applicants should seek clarification where necessary and confirm their understanding of regulatory expectations. Taking detailed notes during the meeting helps ensure that important points are accurately captured and reflected in subsequent development planning.

Understanding Your ISA Report

Following the ISA meeting, applicants receive a written ISA report. This document provides a consolidated summary of the discussions and the regulatory advice offered. It reflects the agreed positions, clarifies regulatory expectations, and may identify areas where additional data or justification is required.

Applicants should carefully review the ISA report and integrate the recommendations into their development strategy. The report serves as an important reference for future regulatory interactions and helps maintain alignment with UK regulatory standards.

For more detailed insights, click the below link Get more help to apply for medicines Integrated Scientific Advice (ISA)