Lightning Health’s Post

England to Relaunch ILAP from March 2025 The UK government has announced plans to relaunch the Innovative Licensing and Access Pathway (ILAP) to accelerate the introduction of new medicines to the NHS. Based on stakeholder feedback, the revamped ILAP will feature: 🔹 New Entry Criteria: More selective and clear criteria for entry. 🔹 Enhanced NHS Collaboration: Increased dialogue and collaboration with the NHS. 🔹 Bespoke Service: A tailored approach with a simpler roadmap and predictable timelines. 🔹 Focus on Early Development: Targeting medicines that have not yet entered confirmatory trials. 🔹 Future-Proofing: Broadening to include drug-device combinations. Applications for the new ILAP will open in March 2025, with further details to be released in January 2025. The current ILAP system will stop accepting applications after November 20, 2024. This relaunch aims to ensure that the most transformative new medicines reach patients more efficiently, marking a significant step forward for the UK’s healthcare system. #ILAP #InnovativeLicensing #Medicines #MHRA #NHS #UKHealthcare

📣 New legislation introduced today marks the biggest overhaul of UK clinical trial regulations in 20 years. The new regulations will be implemented in January 2026 Key benefits for distributors: ✅ Faster approvals for groundbreaking medicines. ✅ Reduced administrative burdens, saving time and effort. ✅ Strong safety standards maintained throughout. With a 12-month transition period to prepare, these changes will help the UK remain a top destination for clinical research—great news for patients, researchers, and the industry. Stay updated 🔗 https://lnkd.in/eFyK_ynC

An exciting development reached the UK Clinical Trials industry today! New legislation is being laid out which is aimed at making regulatory framework for Clinical Trials more efficient, streamlined and adaptable. This is the biggest overhaul of Clinical Trial regulations in 20 years. The aim of the reforms is to: ✅ Promote public health ✅ Evolve new and improved medicines ✅ Remove obstacles to innovation while ensuring safety of Clinical Trials ✅ Streamlining regulations ✅ Ensure legislation allows for trial sponsors to conduct studies across multiple countries This exciting development is fantastic news for growth in the Clinical Trials, both in the UK and further afield. Read the full press release here ⬇️ https://lnkd.in/gH_84-ed #clinicaltrials #clinicalresearch

New Clinical Trials legislation has been laid in Parliament today that will address the research sector's need for a more efficient, streamlined and adaptable regulatory framework for clinical trials. The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) will now begin implementing the biggest overhaul of clinical trials regulations in 20 years. These reforms will make the UK a more attractive place for innovators to conduct important research and will help to get potentially life-changing new treatments to patients and the NHS as quickly as possible. Once made into law, the new legislation will come into force following a 12-month implementation period to ensure readiness, with support from health system partners including the Health Research Authority (HRA), academia and researchers. Read the full article: https://lnkd.in/gH_84-ed #NIHRIndustry #LifeSciences

📣 Medicines and Healthcare products Regulatory Agency: Patients, the NHS and the life sciences sector are set to benefit from a new clinical trials framework being laid in parliament today. New clinical trials legislation has been laid in UK Parliament on 12 December, that will address the research sector's need for a more efficient, streamlined and adaptable regulatory framework for clinical trials. The new legislation will make the UK a more attractive place for innovators to conduct important research and will help to get potentially life-changing new treatments to patients and the NHS as quickly as possible. Dr June Raine, our Chief Executive said: “A major milestone for clinical trials regulations has been achieved today. “After extensive public consultation and expert input, we’re introducing regulations that eliminate unnecessary duplication and accelerate approvals. “These reforms protect the safe development of pioneering new treatments for the benefit of patients and the NHS, setting the UK as one of the best places in the world to conduct research for patients, researchers and innovators” To read the full release, visit ➡️ https://bit.ly/3ZTxuUX

New Clinical Trials legislation has been laid in UK Parliament to address the research sector's need for a more efficient, streamlined and adaptable regulatory framework for clinical trials. These significant changes are the most comprehensive reform in 20 years and, once made into law, the new legislation will come into force following a 12-month implementation period. The legislation aims to reduce unnecessary administrative burdens on trial sponsors without compromising patient safety. It will see duplicative requirements removed and processes streamlined, with the introduction of the combined review and notification scheme for some clinical trial initial applications and amendments embedded into law. Grace Hawes, Associate Project Director at MAC, shared her thoughts on the reforms: “MAC welcomes these changes. Streamlining and removing obstacles is very positive and will undoubtedly make the UK an even more attractive place for our Sponsors to conduct clinical research, ultimately helping to expedite the release of life-changing treatments to patients.” Find out more in the MHRA’s press release here: https://lnkd.in/gH_84-ed #UKLegislation #ClinicalTrials #clinicalresearch #cro

🎉A Major Milestone for UK Clinical Trails🎉 New legislation in the UK is set to make the approval of clinical trials more "efficient, streamlined and adaptable" making the UK an attractive spot for CRO's🤩 This new legislation will be enforced following a 12-month implementation period. Faster approvals means faster results. Will this result in a boom in the UK CRO market? 👀

As of 18 June, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency apply, and will impact patients, health care professionals and sponsors. The revised rules aim to simplify the submission of data and documents, but also include several changes that could impact the treatment of commercially confidential information and protection of patient data. #clinicaltrials #EU

As of 18 June, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency apply, and will impact patients, health care professionals and sponsors. The revised rules aim to simplify the submission of data and documents, but also include several changes that could impact the treatment of commercially confidential information and protection of patient data. #clinicaltrials #EU

As of 18 June, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency apply, and will impact patients, health care professionals and sponsors. The revised rules aim to simplify the submission of data and documents, but also include several changes that could impact the treatment of commercially confidential information and protection of patient data. #clinicaltrials #EU