Mujahed Khan Pathan’s Post

📌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

FDA publishes final guidances Q2(R2) and Q14 The Food and Drug Administration (FDA) announced in March 2024 the availability of the following fiinal guidances for industry on its website. Q2(R2) Validation of Analytical Procedures, which  provides a general framework for the principles of analytical procedure validation. Q14 Analytical Procedure Development, which describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug product. Both documents were made available for download on the ICH website at the end of 2023. The European Medicines Agency (EMA) has announced that Q14 is effective from 14 June 2024 #RegulatoryAffairs #RegulatoryGuidance #QualityAssurance The documents can be downloaded using the links shown below: https://lnkd.in/gMwM7QBH https://lnkd.in/gekJKHq4

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

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

🔸Myanmar is a member of the ASEAN (Association of Southeast Asian Nations) region, where the regulation of Nutraceuticals falls under the purview of the Food and Drug Administration (FDA). 🔸The registration process for nutraceuticals begins with the submission of an application, referred to as Form I Registration. 🔸Once the Form I Registration is submitted, the next step in the process is the submission of a detailed dossier. This comes after the FDA screens the application, ensuring that all regulatory requirements are met before approval. 🔸Following the dossier submission, product samples, along with the required documentation, are submitted to the FDA. These samples must meet specific conditions and comply with regulations to ensure smooth approval. 🔸Once all requirements are successfully met, the FDA begins its evaluation process, ultimately leading to approval and issuance of Drug Registration Certificate. This crucial step marks a significant milestone in bringing new products to market and ensuring their safety and efficacy for consumers. 💫At Rx Solution, we simplify the complex FDA approval process, helping you meet regulatory requirements with ease and efficiency. ✅Let us guide you every step of the way, ensuring a smooth path to approval and market readiness. #RxSolution #RegulatoryAffairs #FDA #Myanmar

📢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

|WHO Listed Regulatory Authorities| WLA (24th May 2025) World Health Organization A WHO Listed Authority (WLA) is a regulatory authority (RA) or a regional regulatory system (RRS) that complies with all the relevant indicators and requirements specified by WHO for regulatory capability as defined by an established benchmarking and performance evaluation process. A regulatory authority provides the framework that supports the WHO recommended regulatory functions. This is the authority and affiliated institutions that are responsible for regulatory oversight of medical products in a given country or region and in charge of assuring the quality, safety and efficacy of medical products as well as ensuring the relevance and accuracy of product information. The WLA replaces the Stringent Regulatory Authority (SRA) definition https://lnkd.in/ddW_5zEW #RegulatoryAffairs #QualityControl #QualityAssurance #ResearchAndDevelopment #Pharmaceuticals #Biotechnology #LifeSciences #MedicalDevices #ClinicalResearch #RegulatoryCompliance #GMP #FDARegulations #HealthcareQuality #DrugDevelopment #ComplianceManagement #RegulatoryScience #RnD #BioPharma #ProductDevelopment #RegulatoryUpdates #PharmaRegulation #HealthAuthority #DrugRegulation #PharmaCompliance #RegulatoryAffairs #FDA #EMA #MHRA #TGA #HealthCanada #PMDA #SFDA #NMPA #ANVISA #CDSCO #Drap #nafdac #efda #gfda. #who #pics #sahpra

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

FDA published new guidelines for Data Integrity In Vivo Bioavailability and Bioequivalence Studies.  #regulatory #regulatoryaffairs #regulatoryaffais #regulatoryaffairs #Africa #ASEAN #CIS #LATAM #regulatedmarket #USFDA #regulatoryupdates #regulatorystrategy #regulatoryrequirements #BA #BE #CDSCO #nswsportal #sugamportal #CIScountries #regulatory #regulatoryscience #regulatoryinsights #Dossier #regulatorysubmissions #submission #dossier #cmc #regulations #pharmaceuticalcompanies #PICS #ICH #EMA #healthcanada #IND #EgyptFDA #cmc #drugs #compliance #diwakarshuklaregulatoryaffairs