Cell and Gene Therapy Catapult’s Post

📢 UK businesses: Are you ready for the Windsor Framework in 2025? Don't let Brexit changes catch you off guard! Our blog post breaks down the key points of the Windsor Framework, including: 🔹 New medication supply plans for Northern Ireland 🔹 Unified packaging and labelling across the UK 🔹 Solutions to Northern Ireland Protocol challenges Plus, learn how APCER can support your compliance with new MHRA requirements. Stay ahead of the curve - read our blog now! #WindsorFramework #BrexitUpdates #UKBusiness #pharmacovigilance #regulatorycompliance #PackagingandLabelling https://shorturl.at/3vsm7

The U.S. Food and Drug Administration (#FDA), #HealthCanada, and the Medicines and Healthcare products Regulatory Agency (#MHRA) have jointly issued the “𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬.” The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles builds upon the "𝐆𝐨𝐨𝐝 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 (𝐆𝐌𝐋𝐏) 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" and the"𝐏𝐫𝐞𝐝𝐞𝐭𝐞𝐫𝐦𝐢𝐧𝐞𝐝 𝐂𝐡𝐚𝐧𝐠𝐞 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐏𝐥𝐚𝐧𝐬 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" both published jointly by the FDA, Health Canada and MHRA. Transparency across health care must be an international priority. Read documents here: https://lnkd.in/eHqupz_i https://lnkd.in/eGqcaY4k

The Medicines and Healthcare products Regulatory Agency has published an update to the guidance on clinical trials for medicines specifically pertaining to how to manage authorisation and report safety issues.  - To discuss this guidance with a member of the team, get in touch www.scendea.com/contact - #guidanceupdate #clinicaltrials #drugdevelopment #regulatoryaffairs

The Medicines and Healthcare products Regulatory Agency has updated guidance on handling of active substance master files and certificates of suitability. Initially published on 31st of December 2020, the guidance summarises the ASMF compilation and submission process - To discuss this update and for expert regulatory guidance, speak to a member of the team today www.scendea.com/contact - #MHRA #regulatoryaffairs #drugdevelopment

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new Medicines Pipeline data program, requesting information on planned or potential future submissions from current and potential Marketing Authorisation Holders (MAHs). This initiative aims to improve the agency's service delivery and assessment timelines. Key points for MAHs to consider: 📌Scope: Provide information on expected submissions up to 5 years in advance, 📌Data required: Product details, active ingredients, product types, indications, expected submission dates and routes, and additional MHRA services needed. 📌Submission Process: Download the template spreadsheet from the MHRA website, fill it with available information, and submit. 📌Updates and Flexibility: Expect to provide updates approximately every 6 months. The MHRA acknowledges that plans may change over time. 📌Participation: All current or prospective MAHs are encouraged to participate, regardless of company size and number of projects. The MHRA emphasizes that this initiative will help them efficiently resource teams, ensure consistent timeline delivery, and prepare for potentially transformative technologies. This proactive approach aims to benefit both the industry and patients through more efficient application processing. Click here to learn more https://lnkd.in/e3t-6iyK #MHRA #medicinespipeline #marketingauthorisation

The U.S. Food and Drug Administration (#FDA),#HealthCanada, and the Medicines and Healthcare products Regulatory Agency (#MHRA) have jointly issued the “𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬.” The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles builds upon the "𝐆𝐨𝐨𝐝 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞 (𝐆𝐌𝐋𝐏) 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" and the"𝐏𝐫𝐞𝐝𝐞𝐭𝐞𝐫𝐦𝐢𝐧𝐞𝐝 𝐂𝐡𝐚𝐧𝐠𝐞 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐏𝐥𝐚𝐧𝐬 𝐟𝐨𝐫 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠-𝐄𝐧𝐚𝐛𝐥𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: 𝐆𝐮𝐢𝐝𝐢𝐧𝐠 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐥𝐞𝐬" both published jointly by the FDA, Health Canada and MHRA. Transparency across health care must be an international priority. Read documents here: https://lnkd.in/dK-X6-Zw https://lnkd.in/ejqWRmV3

Did you miss yesterday's Decentralized Manufacturing Working Group meeting on Regulatory Considerations, or want a recap? Ursula Busse (Tigen) & Ian Rees (Formerly Medicines and Healthcare products Regulatory Agency) presentation on Regulatory Aspects for Decentralized Manufacture, a comparison of how the UK, USA & EU regulatory bodies approach regulation, and the scope for international collaboration is available to view on the Phacilitate Network, along with the following open discussion. Let me know if you have any difficulty accessing this and the slides. #Decentralizedmanufacturing #celltherapy #pointofcare #celltherapymanufacturing #cellulartherapies #DCMWG #ICMRA #EMA #FDA #MHRA #regulatory

[Webinar 💻] PRIME scheme – A tailored development 📅 Date: July 30th, 3 PM CET 🔗 Register now: https://lnkd.in/dK3eACnu In 2016, the EMA has launched the PRIority MEdicines (PRIME) scheme to foster the development of medicines with major public health interests and accelerate the regulatory pathway. The main goal of the PRIME scheme is to facilitate the generation of robust data supporting compliance to regulatory requirements and identifying emerging issues in the development. This program applies to medicinal products that target an unmet medical need, so they can reach patients earlier and may significantly improve their quality of life. Want to learn more about the eligibility criteria and the procedure for the PRIME scheme? Don’t miss the next ProductLife Group x Zwiers Regulatory Consultancy BV Webinar! #PRIME #prioritymedicines #regulatoryaffairs #medicinalproducts #pharma #compliance #lifescience #healthcare #webinar

With the United Kingdom’s exit from the European Union, staying updated on regulatory changes is crucial for business success. Starting January 1, 2025, the Windsor Framework will come into effect, introducing significant updates. Our team of regulatory experts is here to guide you through the new MHRA requirements. Want to know more? Read our blog: https://bit.ly/4fKROyA #WindsorFramework #regulatorycompliance #pharmacovigilance #pharmacovigilanceservices #MHRA #EMA #APCER #UKBusiness #NorthernIreland #Medicines #BrexitRegulations #PharmaCompliance

The Medicines and Healthcare products Regulatory Agency has updated information on their webpage for pre-submission advice and support which now includes the pre-submission notification form. - To discuss this guidance update with a member of our team, get in touch now www.scendea.com/contact - #guidanceupdate #MHRA #drugdevelopment #regulatoryaffairs