MENA Region: Pharma Market Access’ Post

important documents required for submission dossiers in JFDA The Jordan Food and Drug Administration (JFDA) published Guidance for the most important documents frequently requested in the drug dossiers submitted for registration with the Jordan Food and Drug Administration #regulatoryaffairs #regulatoryaffais #regulatoryaffairs #regulatoryupdates #regulatorystrategy #regulatoryrequirements #regulatory #regulatoryscience #regulatoryinsights #Jordan #regulatorysubmissions #submission #dossier #cmc #regulations #pharmaceuticalcompanies #cmc #drugs #compliance #diwakarshuklaregulatoryaffairs

important documents required for submission dossiers in JFDA The Jordan Food and Drug Administration (JFDA) published Guidance for the most important documents frequently requested in the drug dossiers submitted for registration with the Jordan Food and Drug Administration #regulatoryaffairs #regulatoryaffais #regulatoryaffairs #regulatoryupdates #regulatorystrategy #regulatoryrequirements #regulatory #regulatoryscience #regulatoryinsights #Jordan #regulatorysubmissions #submission #dossier #cmc #regulations #pharmaceuticalcompanies #cmc #drugs #compliance #diwakarshuklaregulatoryaffairs

📢The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “𝑹𝒆𝒒𝒖𝒆𝒔𝒕𝒔 𝒇𝒐𝒓 𝑹𝒆𝒄𝒐𝒏𝒔𝒊𝒅𝒆𝒓𝒂𝒕𝒊𝒐𝒏 𝒂𝒕 𝒕𝒉𝒆 𝑫𝒊𝒗𝒊𝒔𝒊𝒐𝒏 𝑳𝒆𝒗𝒆𝒍 𝑼𝒏𝒅𝒆𝒓 𝑮𝑫𝑼𝑭𝑨.” 📄This guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. The guidance reflects the most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III) and clarifies what matters are appropriate for requests for reconsideration. The guidance finalizes the draft guidance for industry of the same title issued on January 11, 2024. 𝐒𝐭𝐚𝐲 𝐢𝐧𝐟𝐨𝐫𝐦𝐞𝐝, 𝐬𝐭𝐚𝐲 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭! #IndustryGuidance #RegulatoryAffairs #FDA #GDUFA #ANDASubmissions #PharmaUpdates #DrugApproval #PharmaceuticalIndustry #AdaptisPharma #HumanSafety #GenericDrugs #ANDA #regulatorycompliance #ANDAparking #USagent #APIMF #drugregulatory #USFDA #RegulatoryServices #PharmacovigilanceServices #UKMarkt #CanadaMarket #USMarket

📌Therapeutic Goods Administration (𝗧𝗚𝗔) 𝗔𝗱𝗼𝗽𝘁 𝟭𝟭𝟮 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀, enhancing the regulatory framework for therapeutic goods in Australia by leveraging the work done by international regulatory counterparts. 𝙃𝙚𝙧𝙚 𝙖𝙧𝙚 𝙩𝙝𝙚 𝙠𝙚𝙮 𝙩𝙖𝙠𝙚𝙖𝙬𝙖𝙮𝙨: 🔸 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗔𝗹𝗶𝗴𝗻𝗺𝗲𝗻𝘁: The TGA aligns with international regulatory counterparts, such as the European Union (EU) Guidelines, International Conference on Harmonisation (ICH), and the Food and Drug Administration (USA). 🔸𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗔𝗱𝗼𝗽𝘁𝗶𝗼𝗻: Before adopting any guideline, the TGA undertakes extensive internal and external consultations to ensure consistency with Australian requirements. 🔸𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝘁𝗼 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀: The guidelines apply not only to prescription medicines but also to over-the-counter (OTC), complementary, and some listed medicines. 🔸𝗗𝗲𝘃𝗶𝗮𝘁𝗶𝗼𝗻 𝗝𝘂𝘀𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: While the guidelines are not mandated by legislation, any deviation from them in an application must be justified. This reflects a move towards a harmonized approach to regulatory guidance globally. 𝙃𝙚𝙧𝙚'𝙨 𝙩𝙝𝙚 𝙇𝙞𝙣𝙠🔗: https://lnkd.in/eAaj3nK6 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs #pharmaceuticals

📢 Regulatory Update - Starting January 1, 2025, all medicinal products in the UK must be labelled 'UK Only' due to the Windsor Framework. This framework ensures that medicines can be approved UK-wide by the MHRA and excludes Northern Ireland from EU Falsified Medicines Directive requirements. These products will only be sold in the UK and not in the EU, except under special conditions. 👉 To read more, visit: https://lnkd.in/dHFx3WWQ At Qinecsa, we make meeting regulatory requirements to a high standard easy and effective. If you would like our team of experts to assist you, do not hesitate to get in touch: https://lnkd.in/d-GbDzrm #Pharmacovigilance #InnovativeTech #DrugSafety #RegulatoryAffairs #RegulatoryCC #MHRA #WindsorFramework

𝐅𝐃𝐀 𝐡𝐚𝐬 𝐩𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝 𝐟𝐢𝐧𝐚𝐥 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐀𝐍𝐃𝐀 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬 | 𝐀𝐦𝐞𝐧𝐝𝐦𝐞𝐧𝐭𝐬 𝐭𝐨 𝐀𝐛𝐛𝐫𝐞𝐯𝐢𝐚𝐭𝐞𝐝 𝐍𝐞𝐰 𝐃𝐫𝐮𝐠 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐔𝐧𝐝𝐞𝐫 𝐆𝐃𝐔𝐅𝐀 This guidance is intended to explain to applicants how the assessment goals established as part of the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s assessment goal dates. This guidance supersedes the July 2018 guidance for industry ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA. To Know more write to us at bd@pharmazones.com or visit our website at www.pharmazones.com #Pharmazone #Pharmazoneregulatory #FDA #ANDA #ComplianceMatters #NewDrugApplications #GCP #GMP #GMPAudit #compliance #vendorqualification #regulatoryaffair #Pharmacovigilance #ICSR

Understanding Drug Safety: EMA vs. USFDA on Nitrosamine Guidelines Explore key points about how European and U.S. agencies manage drug safety for nitrosamines: - Scope: EMA covers a wide range of products; USFDA focuses on specific drug types. - Safety Measures: Both discuss safety, but with different priorities and details. - Testing and Risk: EMA focuses on developing methods; USFDA emphasizes testing validation. - Setting Safety Limits: EMA uses broad data; USFDA sets specific intake limits. For a full comparison, check the linked table in the comments. 🔍 Any discrepancies or thoughts? Drop a comment below! 🔄 Feel free to share this post! #Regulations #pharma, #regulatory #pharmaindustry #EMA #fda #eu #CDSCO #Healthcare #kaust #eda #algeria #safety #nitrosamine #usfda #sfda #gcc #middleeast #knowledgesharing #learning

Auditores FDA Should Implement Strategies to Retain Its Inspection Workforce Report GAO-25-106775 Publicly Released on: Nov 13, 2024 . Published: Nov 13, 2024 . … Drug Safety: FDA Should Implement Strategies to Retain Its Inspection Workforce Fast Facts The Food and Drug Administration paused many drug manufacturer inspections during the COVID-19 pandemic. Inspections help ensure that the drugs … needs with addressing turnover. Skip to Highlights Highlights What GAO Found After disruptions during the COVID-19 pandemic in 2020, the Food and Drug Administration (FDA) had largely resumed conducting in-person inspections of foreign and domestic drug manufacturers by March 2022. Ref.: United States Government Accountability Office - Report to Congressional Requesters

Today we remember the creation of the Food and Drug Administration (FDA), the main health surveillance agency in the USA and a guiding light for the global regulatory ecosystem. The institution initially emerged under the Pure Food and Drug Act. It gained relevance and responsibilities in the following decades, especially after the enactment of the Food, Drug, and Cosmetic Act of 1938. As a central drug control initiative in the US, the FDA directly influences debates on regulatory frameworks around the world, which makes it crucial for setting safety, efficacy and quality standards for drugs and medical devices. As an ethical and health benchmark for the top global destination for clinical trials, the FDA plays a central role in promoting good clinical practices and creating efficient and responsible processes for conducting studies. #regulatory #pharma #fda

Finance Minister Nirmala Sitharaman said India needs a 'Bharat Food and Drug Administration' to set global pharma standards. "You don't need a US FDA standard... Can we in India not have a Bharat FDA, which can give global standards of benchmarks," #usfdaaprrovel #bfdaapprovel #bigstatement #pharmanews #pharmaupdates #pharmaceuticalindustry #abhisanaupdate #pharmacy