Medicines and medical devices play a crucial role in maintaining and restoring public health and well-being. Quality-assured products ensure their effectiveness, whereas poor-quality medicines and devices can fail to treat diseases, cause harm, and, in extreme cases, lead to death. Additionally, substandard medicines may contribute to drug resistance. National Medicines Regulatory Agencies (NMRAs) are tasked with the registration and authorization of safe, effective, and quality-assured products. To ensure that the quality of these medical products is upheld until they reach the patient, NMRAs implement post-marketing surveillance (PMS) programs. What are the biggest challenges faced by regulatory agencies in ensuring the effectiveness of post-market surveillance programs? #MedicalDevices #Healthcare #PatientSafety #PostMarketSurveillance #Innovation
Mawuli Adzraku’s Post
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🚀 Exciting Updates in Therapeutic Product Regulation 🚀 Excited to share the latest edition (2.0) of the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ). This comprehensive document covers crucial aspects like legislation, types of therapeutic products, and the regulatory framework ensuring safety, quality, and efficacy. For all industry professionals, this is a must-read to stay updated with the regulatory standards. 📄 Read the full document #Healthcare #Regulation #MedicalDevices #Medicines #NewZealand #TherapeuticProducts
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Post-market surveillance (PMS) is the continuous monitoring of medications after they have been approved and released to the market. It ensures ongoing safety and effectiveness for all patients. Key Aspects of Post-Market Surveillance: ☑️Adverse Event Reporting: Collection and analysis of reports on side effects and adverse reactions from healthcare providers and patients. ☑️Safety Updates: Regular updates and reviews of medication safety profiles to identify new risks or side effects. ☑️Regulatory Actions: Issuing warnings, revising labels, or even withdrawing medications if new evidence shows they are unsafe. ☑️Real-World Data: Gathering information on how drugs perform in broader, diverse populations beyond controlled clinical trials. ☑️Patient Engagement: Encouraging patients to report any adverse effects to improve drug safety and efficacy. ☑️Global Efforts: International cooperation helps standardize PMS practices, ensuring medications are safe for everyone, everywhere. #PharmaRegulations #PostMarketSurveillance #DrugSafety #PublicHealth #Healthcare
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DentalMonitoring Sets New Standard In Orthodontic Remote Monitoring With De Novo Approval By the U.S. Food and Drug Administration (FDA). https://lnkd.in/eTeQqVYd #AITech365 #clinicalcare #DentalMonitoring #FDA #HealthcareManagement #news #orthodontictreatment #remotemonitoring
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#MedSafetyWeek 💊⚕ 📌#EveryReportCounts - Report Medicine Side Effect or Suspected Adverse Drug Reactions. Help make medicines safer for everyone. Tell your medical professional about the side effect or report to the medicines regulatory for your region on the Island of Ireland. By doing so, it will help make drug/medication use safer for everyone. Report suspected side effects from medicines, including new treatments or medicines that have been taken a long time. In Rep of Ireland, it is reported to Health Products Regulator Authority (HPRA). https://lnkd.in/ewzXxA3S In Northern Ireland it is reported to the Medicines & Healthcare Regulatory Agency (MHRA) https://lnkd.in/epenmwAm #MedSafetyWeek2024 #MedicationSideEffects
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Regulatory bodies play a vital role in protecting public health by ensuring that new drugs are safe, effective, and manufactured to the highest quality standards. This comprehensive overview covers key regulatory bodies, their methodologies, and the importance of their work in drug development and public health protection. #regulatorybodies #drugdevelopment #clinicalresearch #dcgi #fda #ema #pmda #cdsco #clinicaltrials #dphsindia #dphs
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Ever wonder about the medicines you take and how they got on the market? I talk about the hidden risks of medicine and explain the ins and outs of the FDA approval process including my work on the FDA Drug Safety and Risk Management Committee on The Health And Wealth Power Hour with Harlon Pickett. Additional discussion topics include: 🔺Potential long term effects of taking medicines for a prolonged period 🔺Deprescribing and cutting back on meds 🔺Questions to ask your doctor 🔺Pharmacists as an information resource Do you research the medicines you take? #medicine #sideeffects #FDA
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#Medicine_Safety_Alert_Notification #Medication_Name and #Strength: Arthemeter 80mg/ml injection #Manufacturer: Shinepharma, China #Manufacturing_date: 11/2023 #Batch_Number: 231104SPF #lssue: Not registerd as well as found to be Substandard #Method_of_Detection: Through Post marketing medicine quality surveillance system #Action_Required: For healthcare professionals: - Discontinue prescribing and administering - Contact affected patients and provide guidance on alternative treatments. - Patients should stop taking immediately. - Report any side effects to National Pharmacovigilan center, regional pharmacovigilance center and branch EFDA pharmacovigilance unit.
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These figures are scary especially when considering this is with respect to just ONE #CompetentAuthority. Imagine how this adds up across the #EU? It's disappointing that there are people out there who are praying on the vulnerable to make a 'fast buck' without any care about causing distress, harm or even, fatalities. We can all support our Regulators by keeping an eye out for #FalsifiedMedicines and #FakeMedicines and reporting as appropriate. We must all be #Vigilant. #HereToHelp
Our Director of Compliance Grainne Power spoke to RTE today to highlight the health risks associated with buying fake and illegal prescription medicines online. Ms Power stressed the dangers of sourcing prescription medicines outside of a registered pharmacy and without medical supervision. Data released today shows we detained almost 900,000 illegal medicines in 2023. Listen back to Ms Power’s interview: https://lnkd.in/eaEHNjv5 #PublicHealth #FakeMedicines #IllegalMedicines
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🔴 One of the most pressing problems facing public health providers and administrators in many countries is ensuring the rational use of drugs. 💡One mechanism to ensure correct prescribing and use is the drug utilization review (DUR) process. 🔶"Drug Utilization Review" An Authorised structure ongoing review of prescribing dispensing and use of evaluation. 🔰Objectives of DUR; ◽ Evaluating effectiveness of therapy. ◽ Preventing medication error. ◽ Enhancing responsibility in medicine use process. ◽ Identifying areas in which further information, knowledge is required by healthcare providers. ◽ Controlling medication cost. 👇 Below are the Guidelines of implementation of DUR in Hospitals. Repost! If you find this insightful. #ClinicalPharmacyandTherapeutics #DrugUtilizationReview #DUR #MedicationEvaluation #Safety #Cosfeffectiveness #PharmacyBenifitsManagement #Healthcare #QualityofLife #PharmaceuticalCare #PharmaceuticalScience #PharmacyStudents #RxReminders
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The statistics are alarming, particularly when you think about the implications regarding only a SINGLE #CompetentAuthority. Have you considered the cumulative effect across the #EU? It's disheartening to realise that some individuals exploit the vulnerable for quick financial gain, completely disregarding the potential for distress, harm, or even death. We can contribute to the efforts of our Regulators by being alert to #FalsifiedMedicines and #FakeMedicines and reporting any suspicions. It's important now more than ever for everyone to remain #Vigilant.
Our Director of Compliance Grainne Power spoke to RTE today to highlight the health risks associated with buying fake and illegal prescription medicines online. Ms Power stressed the dangers of sourcing prescription medicines outside of a registered pharmacy and without medical supervision. Data released today shows we detained almost 900,000 illegal medicines in 2023. Listen back to Ms Power’s interview: https://lnkd.in/eaEHNjv5 #PublicHealth #FakeMedicines #IllegalMedicines
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