US Pharmacopeia’s Post

🌍 At the recent 19th International Conference of Drug Regulatory Authorities in India, the importance of global collaboration in strengthening regulatory systems was a key focus. US Pharmacopeia very own USAID-funded PQM+ Program Director Jude Nwokike and Senior Global Health Technical Program Director @Lawrence Evans led a workshop that not only fostered meaningful discussions but also highlighted the critical role of partnerships in enhancing local production of quality-assured medical products. Also attending USP India Senior Director Matruprasad P. 🔍 As we engage in these pivotal conversations, the need for scientific expertise in global public health has never been more apparent. This is where you come in! USP is seeking passionate individuals to join our Expert Volunteer community. By volunteering with us, you can extend your impact beyond the conference room, contributing to the development of standards that ensure the quality, safety, and benefit of medicines and foods. 🌐 Volunteering with USP provides a unique opportunity to work alongside other experts from around the globe to help set the standards that protect public health. Your expertise could be crucial in navigating complex regulatory landscapes and bringing safe, effective medical solutions to all corners of the world. 🤝 If you are attended the conference and have been inspired by the discussions on enhancing regulatory frameworks and ensuring the safety of medical products, consider applying to become a USP Expert Volunteer. Together, we can make a difference that resonates across global communities. 🔗 To learn more about how you can contribute to this vital work and apply, visit https://lnkd.in/eumte8Xv #USPVolunteers #GlobalHealth #PublicHealth #RegulatoryExcellence #ICDRA #PharmaStandards

Regulatory harmonization is essential to promote access to safe, quality and effective medicines and medical products for the African people. Weak regulatory systems have been contributors to late market authorization of drugs. As we work towards harmonization and reliance procedures, National Regulatory Authorities #NRA will have the opportunity to work together and collaborate. Through this, we anticipate that countries will access medicines with ease having reduced the long registration timelines and control for substandard & falsified products in the markets. On Friday during the #RegulatoryAffairs #NetworkingCocktail, stakeholders gathered to share insights on regulatory harmonization and reliance procedures for health product security. Dr. Angeline Achoka, Steve Kipkoti, Juliet Konje and Dr. Robert Miano shared their informed perspective and challenged the stakeholders including young professionals to take up roles and advocate for regulatory harmonization and reliance in the continent. They reiterated the need for professionals and industry players to collaborate in #WorkforceDevelopment and #PolicyShaping with regulators towards efficient regulatory systems. #RegulatorySystemsStrengthening

Are you ready for the EU clinical trial deadline? #QPS Global #RegulatoryAffairs can help to transition EU #clinicaltrial applications to the #EMA #CTIS online system. Learn more information by visiting our page https://shorturl.at/hizGW or email info@qps.com. #clinicalresearch

During the COVID-19 pandemic, differences between regulatory systems in the Americas impacted health self-sufficiency. In response to this challenge, the Pan American Network for Drug Regulatory Harmonization #PANDRH was created. PANDRH focuses on: 🟢Strengthening regulatory systems through cooperation and exchange. 🟢Develop and implement common proposals aimed at regulatory convergence. 🟢Promote good practices and regulatory science in member states. To meet these objectives, the #NRAs Regulatory Authorities of the region will be members of the XI Conference of the Pan American Network for Drug Regulatory Harmonization #CPANDRH, an initiative to achieve health self-sufficiency and the well-being of the population.

'The consultation follows the publication of the draft guideline for review in other parts of the world. The European Medicines Agency (EMA) began a consultation in June, and the US Food and Drug Administration requested feedback on the text earlier in July. Consultations are also underway in Brazil, China, Korea and Japan.   Swissmedic is accepting feedback on the draft until 30 August. Once the consultation phase is complete, the ICH working group will discuss responses received around the world and update the text as needed. ICH anticipates finalization of the document for implementation in local regulatory systems in May 2025.' There are a few consultations going on regarding real world evidence studies. I hope we can have some harmonised approach which will not make manufacturers jumping through loopholes all the time. There is a great need of guidance how to improve data collection in RWE studies and also how to deal with missing data especially considering that standard of care can vary between different regions. #Realworldevidence #clinicaltrials #ICH

𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗶𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 Navigating the landscape of regulatory requirements in clinical trials is important for ensuring the safety and efficacy of new medical treatments. Compliance with stringent guidelines set by regulatory bodies such as the Food and Drug Administration (FDA), and the National Agency for Food and Drug Administration and Control (NAFDAC) is essential. Key regulatory aspects of clinical trials include. ·       Ethical standards ·       Good clinical practice ·       Informed consent process ·       Protocol compliance. ·       Safety reporting ·       Data integrity and transparency #clinicaltrials #clinicalresearch #clinicalstudies #globalhealth #InSiGHtHealthClinical

Read and download our latest whitepaper, titled 'Introduction to EU Regulatory Affairs' written by Head of CMC and Principal Consultant, James Parsley and Senior Consultant, Ellen W. - https://lnkd.in/gnG-yEC4 - Our new whitepaper delves into European Union product classifications, the EU legal basis, and designations that provide incentives for development and unlock early interaction with EU Regulators. We also explore potential points of interaction with the European Medicines Agency and National Authorities and when these are most useful during drug development. Finally, we will provide insight on considerations for clinical trial applications and highlight the MA Application registration pathways available with the EMA. - #whitepaper #drugdevelopment #regulatoryaffairs #EuropeanUnion

The U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly published the "Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles." This document encourages international harmonization and outlines five guiding principles for PCCPs. Access NAMSA's blog post to learn more about how these guiding principles impact medical device developers: https://lnkd.in/djiFK67j #MedTech #MedicalDevices #FDAguidelines #machinelearning

Last week, I had the pleasure of engaging with health authorities and our incredible teams in China and Korea. Our mission, “A safe journey for each individual patient, everywhere,” resonated strongly, fostering promising collaborations. Regulatory agencies and Roche share a passion for improving patient safety and we look forward to the opportunity to achieve our shared goals through further  collaboration. Roche has consistently become a trusted partner for many Pharmacovigilance PV Health Authorities, fostering transparent and constructive dialogues.  In China the main topic of our conversation was around benefit risk assessment and how it is changing. We had good discussions with regulators on topics such as risk communication, and decision making around label changes. It's a significant milestone that Roche was the first healthcare company to meet with Korean authorities to discuss PV. During the symposium, we discussed our Safety department strategy, PV system, and Advanced Therapy Medicinal Products ATMP EMA/FDA regulation. I will never get tired of saying this, we have the best and most talented people in Roche Safety, everywhere. I am deeply humbled to work with you and I am proud of you all! #PatientSafety #Pharmacovigilance #HealthcareInnovation #Roche #Collaboration #GlobalHealth

According to ABHI's Richard Devereaux Phillips, the #UK’s Medicines and Healthcare products Regulatory Agency is preparing to deploy an international recognition framework for #medicaldevices that would allow #medicaldevice manufacturers to bring products to the UK more easily.   #Didyouknow 📌 The #MHRA has announced the International Recognition Procedure  #IRP intended to replace the EC Decision Reliance Procedure  #ECDRP starting January 1st, 2024. Read more about the procedure here: https://lnkd.in/dUxXTqdK IRP will be open to applicants that have already received an authorisation for the same product from one of #MHRA’s specified  #ReferenceRegulators #RRs, i.e., for the purposes of IRO, a #CHMP positive opinion or an #MRDC positive end of procedure outcome is an RR authorisation. IRP can be used for the following types of  #marketingauthorisation  applications #MAAs: 👉 Regulation 50: chemical and biological new #activesubstances and known active substances. 👉 Regulation 51, 51A and 51B: #generic applications 👉 Regulation 52, 52A and 52B: hybrid applications 👉 Regulation 55: new fixed #combinationproducts applications IRP will be open to applicants with existing authorizations from Reference regulators, namely #Australia's Therapeutic Goods Administration,  #Canada's Health Canada | Santé Canada, #Switzerland's Swissmedic,  #Singapore's Health Science Authority Singapore #HSA, Japan's  #PMDA, #USA's FDA, and European Union's European Medicines Agency  and #MemberStates #Competent Authorities. #InternationalRecognitionProcedure #pharma #pharmaindustry