Generics and Biosimilars Initiative (GaBI)’s Post

Experts join forces to improve screening devices to detect substandard and falsified medicines World Health Organization @ Experts join forces to improve screening devices to detect substandard and falsified medicines https://lnkd.in/dCUHpTrv

EMA just published the new guideline on generic development of OIPs This is an important topic for international harmonisation and the Europeans very much favour the PK-based approach instead of PD and clinical endpoints! Important trend also of relevance for international developments and well perceived in the US. https://lnkd.in/edgMEUDB

Great news and hope for families affected by eosinophilic esophagitis (#EoE) !!! EoE can have a devastating impact on children and their families. For parents there is nothing worse than seing your child suffering as essential as eating. At first, it might seem like they’re just a fussy eater, but as symptoms like stomach aches, food regurgitation, or vomiting start to appear, you know something isn’t right. This condition doesn’t just affect the child’s eating; it can lead to missing days of school, failure to gain weight, and even weight loss. There is still so much to do in terms of raising awareness, improving early diagnosis, and expanding care options for families. Innovation in this space is essential to helping children get the support they need sooner. Proud to see these advancements that could make a real difference for so many families. #PediatricHealth #EosinophilicEsophagitis #InnovationInHealthcare #ChildrensHealth #EUHealth #Awareness #PatientCare

"How will the EU- wide assessment of clinical evidence by HTA bodies work in parallel with the Marketing Authorisation review by the European Medicines Agency? How can industry and government bodies best prepare? [...] The EU HTA Regulation (EU 2021/2282) [...] comes into full effect in January 2025. [...] The coming months will be crucial as EU member states and stakeholders navigate the implementation of the HTA Regulation and JCAs." Isabelle Stoeckert, Elena Popa, Inka Heikkinen explain how to prepare for January 2025 in this article in DIA Global Forum.

PN Update: Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Date of authorisation: 27/07/2010, Revision: 23, Status: Authorised

📢 Stay informed with our weekly newsletter! 📢 Don't miss out on our newsletter for the latest industry and regulatory updates. This week’s issue includes: 🔸 The latest amendments to the Declaration of Helsinki. 🔸 A new Statutory Instrument introduced to Parliament outlining measures for implementing Medical Device Regulatory Reform and improving patient safety in the UK. 🔸 Highlights from the MHRA on training multiple WHO polio laboratories around the world. To read more, click here: https://lnkd.in/e9KYFJTj To receive a newsletters directly in your inbox, simply email info@towermains.com with the subject line “Weekly Newsletter Please.” #healthcare #regulatoryupdates #patientsafety #medicaldevices #MHRA #qualityassurance

News for the generic development of orally inhaled drug products Parts of the new guideline were discussed at the GBHI conference last week and two main points were made: 🔹 Charcoal studies probably cannot be replaced by AUC0-30 🔹 In vitro alone may not be covered by adequate correlation data. #drugdevelopment #generics

This week, the ninth annual #MedSafetyWeek will take place, with regulators from 94 countries and 107 organisations participating worldwide to prevent harmful medicine side effects. #MedSafetyWeek is part of international efforts to raise awareness about the importance of reporting suspected medicine side effects to national medicines regulatory authorities, such as the Medicines and Healthcare products Regulatory Agency (MHRA). This year’s campaign, which runs from 4 to 10 November, focuses on correctly using medicines to prevent side effects. Learn more: https://bit.ly/3UZvmJF #medicine

#Webinar alert from The Evidence Base® EU HTA – Achieving broad access fast! What will it take for innovative medicines to succeed? December 3, 2024; 4:30PM CET; 3:30PM GMT; 10:30PM ET Join our discussion on recent national reforms and essential policies to accelerate patient access to groundbreaking medicines. Moderator, Herbert Altmann (Cencora), will be joined by Iga Lipska MD PhD MPH (Health Policy Institute Poland), Francois Meyer and Oriol Solà-Morales (HiTT - Health Innovation Technology Transfer). #heor #healtheconomics #outcomesresearch #healthoutcomes #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthpolicy #JCA #jointclinicalassessment

Medichem proudly attended the Annual Conference of Medicines for Europe in Dublin, celebrating 30 years of advancing #equitable #access to off-patent medicines. Off-patent medicines, crucial to Europe's healthcare, supply 70% of essential treatments, including those for cancer, autoimmune diseases, diabetes, and cardiovascular conditions. Generic medicines comprise over 90% of the EU's critical medicines list, reinforcing our industry's vital role in a resilient European health system. Challenges and opportunities in our sector:  ▶️ Enhancing the value proposition of off-patent medicines for cost-effective treatment options. ▶️ Promoting the use of #genericmedicines and overcoming barriers to their adoption. ▶️ Ensuring the future #supplychain #security of critical medicines through #robust European regulation and policy. ▶️ Innovating existing treatments with value-added medicines to support #sustainable health systems. ▶️ Combining environmental sustainability with improved access to medicines Elisabeth Stampa, President of Medicines for Europe and Board Member of Medichem, called for new EU leadership to prioritize a Critical Medicines Act and adopt new pharmaceutical legislation swiftly. Medichem is proud to support this vital industry and remains dedicated to creating a more accessible future for Europe. https://lnkd.in/dFkwpRGu