SEQ Ltd - Regulatory Affairs Consultants

💡 Access Consortium: Joint Pipeline Meetings Now Open 💡 As of 24 September 2024, pharmaceutical and biotech companies can request pipeline meetings with Access Consortium regulators. These meetings provide an exclusive opportunity to discuss new developments and submission strategies for innovative medicines. 🌍 Topics may include: -Biosimilars, advanced therapies, and complex generics -Real-world evidence & complex trial designs -Harmonized submission challenges -Strategy for novel therapeutic approaches The Heads of the Access Consortium,committed to accelerating access to safe, effective, high-quality medicines for patients. 🔗 Request a pipeline meeting now! Further Information: https://lnkd.in/erw_HvDd #PharmaInnovation #AccessConsortium #RegulatoryAffairs #Biosimilars #AdvancedTherapies

🚨 Regulatory Changes for Reference Medicinal Products (RMPs) from 1 January 2025 🚨   From 1 January 2025, only RMPs authorised for at least 8 years in the UK (or GB prior to 2025) will be valid for generic, hybrid, and biosimilar Marketing Authorisation Applications (MAAs).   🔑 Key Changes: Applications that cannot cite a valid UK-authorised RMP will need to be submitted under a different legal basis, such as a well-established use application or a full mixed dossier application. The use of international comparator products will be extended across the UK, requiring UK-sourced comparator products. If not sourced from the UK, applicants must provide evidence that an international alternative is representative of the UK RMP.   🔹 Category 1 Products: The MHRA will authorise new and innovative medicines via UK-wide authorisations, which can be cited as RMPs for generics, hybrids, and biosimilars. Converted EU authorisations and GB MAs will also be valid as UK-wide marketing authorisations.   🔹 Category 2 Products: Only UK-authorised products will be valid RMPs. European Reference Products (ERPs) will no longer be valid for UK-wide MAAs from 1 January 2025. For NI MAs submitted through MRP/DCP, ERPs can still be cited.   Prepare your applications for these regulatory shifts to ensure smooth submissions from 2025 onwards! #PharmaRegulations #RMP #BiosimilarMAA #GenericMAA #HybridMAA #MHRA #UKPharma #UKWideAuthorisations #ComparatorProducts #FMD #NIPharma #PharmaceuticalIndustry  

🚨 Imvanex Vaccine 🚨 On 19 September 2024, the European Commission recommended extending the use of Imvanex—a smallpox and mpox vaccine—to adolescents aged 12-17. Previously approved for adults, this decision follows EMA's review, which showed a strong immune response and similar safety profile in adolescents as in adults. 🌍 This is crucial for the ongoing mpox outbreak in the DRC and other regions, declared a public health emergency by WHO. Imvanex protects against both clade I and clade II mpox strains, offering hope for vulnerable populations. 🔗 Read more on EMA’s recommendation and WHO prequalification : https://lnkd.in/eF2xir5u #VaccineUpdate #PublicHealth #Imvanex #Mpox #EMA #WHO #AdolescentHealth #Vaccination

🌐 MHRA Opens Applications for AI Airlock Regulatory Sandbox! 🌐 Calling all developers and manufacturers of AI medical devices! The MHRA is now accepting applications to join the AI Airlock regulatory sandbox. This world-leading pilot programme will help fast-track innovative, safe AI devices for patients and the NHS. 💡 Benefits include: -Bespoke testing plans -Collaboration with regulatory experts -Improved understanding of regulatory frameworks & data standards 🔗 Applications are open until Monday, 7 October 2024. Apply now and help shape the future of AI in healthcare! Full details: https://lnkd.in/eyvKUvsK For more details or questions, contact: aiairlock@mhra.gov.uk #AIinHealthcare #MedTech #AIMedicalDevices #Innovation #MHRA #RegulatoryFramework

🚨 Reference Medicinal Products (RMPs) Update: Transition Period Ending 31 December 2024 🚨   As the transition period approaches its end, here’s what Marketing Authorisation Holders need to know regarding Reference Medicinal Products (RMPs) for UK-wide applications:  

📢 Upcoming Webinar: Quality Defects & Recall Management - October 2024 📅 Join us for an insightful webinar on Thursday, 3rd October 2024, from 10:00 AM to 12:45 PM, where the HPRA will present on the crucial topic of Quality Defects and Recall Management. This virtual event is a continuation of the highly successful June 2023 session hosted by BioPharmaChem Skillnet in collaboration with the HPRA. 🔍 What to Expect: Current trends in quality defect and recall management Real-life case studies Best practices and investigation tips to enhance your defect reporting and recall processes This session is highly relevant for anyone involved in quality defect reporting and investigations. 💻 Location: Virtual event 🕒 Date & Time: 3rd October 2024 | 10:00 AM - 12:45 PM 💡 Fee: Free to attend! No registration fees. 🎯 Who Should Attend: Professionals in quality assurance, regulatory affairs, and those handling product recalls and quality investigations. Stay tuned for the full agenda, which will be announced soon. Don’t miss this opportunity to gain valuable insights! 👉 Register now: https://lnkd.in/eijyqdt2 #QualityAssurance #RecallManagement #HPRA #BioPharmaChem #Webinar #Pharma #Biopharma #QualityControl #ContinuousImprovement #EventAlert #PharmaceuticalIndustry

🌟HPRA Drug Safety Newsletter Edition 116 is now released 🌟 The latest edition of the HPRA newsletter includes important updates to support the safe and appropriate use of the following medicines: Chlorhexidine: Inadvertent ocular exposure during surgical site preparation Availability of Educational Materials for Valproate (Epilim) and Topiramate (Topamax) Product information updates recommended by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter The Importance of Reports of Suspected Adverse Reactions to Pharmacovigilance Full details: https://lnkd.in/ewS4cmk3

🚨 Important for Generic, Hybrid, and Biosimilar Applications 🚨   Starting 1 January 2025, only Reference Medicinal Products (RMPs) authorised in the UK (or GB prior to 2025) for at least 8 years will be valid for generic, hybrid, and biosimilar Marketing Authorisation Applications (MAAs).

🌟 CHMP Meeting Highlights: 16-19 September 2024 🌟 The Committee for Medicinal Products for Human Use (CHMP) has recommended: -8 new medicines for approval -12 medicines for extension of their therapeutic indications This is a major step towards providing more treatment options for patients across Europe! Stay updated on these developments as we continue to expand access to innovative and life-saving therapies: https://lnkd.in/enprh9Fz #CHMP #Pharmaceuticals #EMA #NewMedicines #TherapeuticInnovation #Healthcare #PatientCare

🎉 MHRA Approves Fruquintinib (Fruzaqla) for Treatment of Metastatic Colorectal Cancer 🎉 On 20 September 2024, the MHRA approved fruquintinib (Fruzaqla), a new treatment for adult patients with metastatic colorectal cancer (CRC) when other treatments have not worked. CRC begins in the colon and becomes metastatic when it spreads to other parts of the body. Fruquintinib works by stopping tumours from forming new blood vessels, slowing cancer growth. 🔬 Key Clinical Evidence: The approval is backed by two major studies, FRESCO-2 and FRESCO. In FRESCO-2 (691 patients), fruquintinib extended survival to 7.4 months vs. 4.8 months with placebo. Patients also experienced 3.7 months of disease control compared to 1.8 months with placebo. In FRESCO (416 patients), conducted in China, patients lived for an average of 9.3 months vs. 6.6 months with placebo. 💊 Recommended Dose: 5 mg daily for 3 weeks, followed by 1 week of rest, forming one cycle of treatment. 🚨 Side Effects: Common side effects include reduced blood platelets, joint pain, and decreased appetite. As always, the MHRA will closely monitor the safety of this medicine. Patients and healthcare professionals are encouraged to report any side effects via the Yellow Card scheme. This marks a significant step in providing new treatment options for those with metastatic CRC. See full informtion: https://lnkd.in/eWeZytEW #CancerTreatment #ColorectalCancer #MetastaticCancer #Fruquintinib #MHRA #NewMedicine #Oncology #HealthcareInnovation #PatientSafety #Pharmaceuticals #ClinicalTrials