Pharmatech Associates, a USP company’s Post

Are you wondering about the drug approval process in Brazil? Our latest FAQ guide provides valuable insights into the Regulatory framework, traditional medicines, and recent trends shaping the pharmaceutical industry in Brazil. https://lnkd.in/g9T3uxpM #MedicinalProducts #Brazil #ANVISA #DrugApproval #Regulations #RegulatoryFramework #PharmaceuticalIndustry #TraditionalMedicines #HerbalMedicines #RegulatoryAffairs #FreyrSolutions

Quality concerns persist in the Indian pharmaceutical industry, epitomized by recent incidents like the EzriCare & Delsam Artificial Tears recalls, resulting in deaths and serious health consequences. With India exporting 40% of generic drugs to the US, stringent oversight is crucial. While occasional FDA inspection ramp ups may sound sexy, I'm not sure that it is a sustainable approach for several reasons... Additionally, if the US legislative body was functional, they could provide incentives for domestic manufacturers to boost production and reduce reliance on external markets thus, address quality issues and ensure public health safety. Read: https://lnkd.in/e49EyjMA

🚨 FDA Intensifies Inspections of Indian Drug Manufacturers in 2024 🚨 In light of growing quality concerns, the FDA has stepped up its scrutiny of Indian pharmaceutical companies. This article sheds light on the recent surge in inspections and its implications for the global healthcare landscape. Stay informed and stay ahead!

I and my coauthors Vijay Satapara and Kajal Patel are happy to share review article on "Nitrosamine Contamination in Pharmaceuticals: Regulatory Perspectives and Control Strategies of USFDA, EMA & HC", recently published in International Journal of Drug Regulatory Affairs - March-2024 edition. Abstract: Various regulatory authorities were notified the presence of nitrosamine impurities in human medicines including angiotensin II receptor blockers (ARBs), ranitidine, nizatidine and metformin in 2018. The presence of nitrosamines led manufacturers to assess their products by any means that might inadvertently lead to nitrosamine content and taking steps to mitigate these risks after issuance of safety alerts, recall and withdraw certain batches of these drugs. Importantly, global cooperation by regulatory authorities triggered the investigation of synthetic route, rapid development of analytical procedures and publication of guidelines. This article highlights mainly on risk assessment and control strategies adopted by United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA), and Health Canada (HC) regulatory bodies. Additionally, compare the acceptable intake (AI) values recommended by these regulatory authorities which will help the manufacturer to either limit or eliminate nitrosamines impurities in their medicines because nitrosamines are probable or possible human carcinogens, hence, it is recommended that the potential causes of nitrosamine formation as well as any other pathways observed and evaluate the risk for nitrosamine contamination or formation in their APIs and drug products. Manufacturers should prioritize evaluation of APIs and drug products based on factors such as maximum daily dose, duration of treatment, therapeutic indication, and number of patients treated for the products which are under preapproval stage and already marketed products. Below link is to download the complete article: https://lnkd.in/dzWKaeNh  

🔍 Expanding Access to Quality Medicines: Join the Call for Collaboration! 🔬The US FDA's List of Off-Patent, Off-Exclusivity Drug Products without an Approved Generic (OPOE) serves as a beacon for enhancing transparency and fostering competition in pharmaceutical markets. U.S. Pharmacopeia (#usp) stands committed to supporting this initiative, aiming to accelerate access to vital generic drug therapies while upholding rigorous quality standards. 📈Recognizing the shared goal of ensuring patient access to safe, quality medicines, USP is initiating a Call for Collaboration. This collaborative effort unites patient advocacy groups, FDA, pharmaceutical manufacturers, and USP to prioritize the development and manufacturing of generics for legacy drugs lacking alternatives. Your participation is crucial in amplifying the patient's voice and leveraging the technical expertise of stakeholders. For more information, visit: CallforCollaboration@usp.org 💊Read more on the US FDA OPOE List here: https://shorturl.at/hirBO 🌐Read more on the USP's Call for Collaboration initiative here: https://shorturl.at/zGT56 RegTrac provides regulatory partner & support services for pharmaceutical products. Get in touch with us to schedule a 30-minute consultation with our experts at info@reg-trac.com | www.reg-trac.com #patientaccess #QualityMedicine #CallforCollaboration #healthcareforall #pharmaceuticals #fdaapproval #genericdrugs #medicalinnovation #medicalinnovations #publichealth #drugdevelopment #healthequity #researchmatters #drugsafety #healthcareheroes #accessiblehealthcare #globalhealth #MedicationAccess #healthcareadvocacy #patientcare #healthtech #communityhealth #healthcareindustry #healthcarepartnerships #patientsafety #patientaccess

Like the rest of the Europe, the Czech Republic has faced shortages of certain pharmaceuticals, including antibiotics and drugs for fever reduction for children in the final months of 2022. As a result, the Ministry of Health, together with the State Institute for Drug Control, recently took steps to ensure the supply of scarce pharmaceuticals. For more details on how the Czech Republic and EU are responding to pharmaceutical shortages, follow this link to our article which we have drafted together with Tomáš Matějovský #CMS #law #healthcare #lifesciences #pharmaceuticals #health

Revised Schedule M: A Game-Changer for India's Pharmaceutical Industry #boostingqualitystandards #harmonizinginternationalGMP #Indianpharmaindustry #IndianPharmasector #Innovation #InternationalGMPCompliance #Pharmaindustry #pharmaceuticalqualitystandards #PharmaceuticalRegulatoryAffairs #regulatoryefficiency #RevisedScheduleM #safeguardingpublichealth #ScheduleM #streamliningregulatoryprocesses

Revised Schedule M: A Game-Changer for India's Pharmaceutical Industry #boostingqualitystandards #harmonizinginternationalGMP #Indianpharmaindustry #IndianPharmasector #Innovation #InternationalGMPCompliance #Pharmaindustry #pharmaceuticalqualitystandards #PharmaceuticalRegulatoryAffairs #regulatoryefficiency #RevisedScheduleM #safeguardingpublichealth #ScheduleM #streamliningregulatoryprocesses

🚨 Significant Update in the Pharmaceutical Industry 🚨 The Indian drug regulator has recently mandated the closure of 36% of the inspected drug manufacturing units following inspections that revealed critical non-compliance issues. This decisive action underscores the imperative need for stringent quality control and adherence to regulatory standards in the pharmaceutical sector. we recognize the importance of these regulatory measures in ensuring the highest standards of drug safety and efficacy. This development serves as a reminder for all stakeholders in the healthcare and pharmaceutical industries to prioritize compliance and uphold the highest standards of drug manufacturing. At SB Pharma, we are committed to maintaining excellence in our sourcing and manufacturing processes. We work closely with our partners to ensure that our products meet all regulatory and quality standards. Ensuring the safety and efficacy of medications is not just a regulatory requirement but a fundamental ethical responsibility. Let's work together to foster a culture of quality and compliance in our industry. #Pharmaceuticals #DrugSafety #QualityControl #RegulatoryCompliance #Healthcare