The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have officially launched the Integrated Scientific Advice (ISA) service. This programme replaces and formalises the previous joint scientific advice model that had been tested in earlier pilots. By establishing a single-entry point, the agencies intend to reduce administrative burdens and provide pharmaceutical companies with coordinated insights on evidence requirements for both market authorisation and health technology assessment (HTA) through a unified process.
The institutional flow is now consolidated into a single fee structure and a single integrated report. This shift addresses longstanding industry concerns regarding conflicting feedback on pivotal study designs. While the two organisations maintain their independent statutory responsibilities and legal duties, they will now work collaboratively to deliver aligned advice on specific points of potential friction, such as clinical endpoints and patient populations. NICE officials have committed to building directly upon the regulatory advice provided by the MHRA to ensure the highest possible degree of alignment across the product life cycle.
The ISA service is specifically designed for products in clinical development that intend to follow aligned pathway timelines. This strategic coordination aims to support earlier patient access by optimising clinical development plans and mitigating the risk of unforeseen delays during the assessment phase. Furthermore, the regulators will provide clarity on how their requirements differ from those of global bodies such as the Food and Drug Administration or the European Medicines Agency, which assists companies in preparing multi-market entry strategies.
The process begins with an eligibility check, followed by a formal request. Within 15 working days of a request, the ISA team provides a contract and cost estimate. Companies must then submit a briefing book within 20 working days. The advice meeting itself typically lasts between 120 and 180 minutes, depending on the complexity of the project. A final integrated report is delivered within 45 working days of the meeting, or approximately 115 working days from the initial request.
Financial arrangements have also been simplified. Applicants pay a single fee that the agencies apportion internally. This fee is collected in two stages: an initial 70 per cent payment at the start of the process and a final 30 per cent payment upon completion. Small and medium-sized enterprises (SMEs) based in the United Kingdom remain eligible for a fee waiver on the MHRA component of the service, provided they hold approved SME status.
The report remains non-binding and reflects current scientific and regulatory knowledge. Once companies receive the final document, they may ask up to three factual clarification questions to ensure they fully understand the recommendations. This formalised engagement model provides developers with enhanced clarity and confidence when seeking internal stakeholder buy-in for significant product investments.
Source: Medicines and Healthcare products Regulatory Agency
Link: Medicines: Get integrated scientific advice from the MHRA and NICE
Date: 20 February 2026
