𝗠𝗮𝗸𝗶𝗻𝗴 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 Sponsors may request changes to their ARTG entry to: 🔸Correct errors. 🔸Some changes may result in a new product classification, requiring a separate ARTG entry unless grouped under the “Groups Order.” 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #qualityassurance #regulatoryaffairs #pharmaceuticals To view or add a comment, sign in 📌𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗹𝗲𝗴𝗶𝘀𝗹𝗮𝘁𝗶𝘃𝗲 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 𝗳𝗼𝗿 𝗹𝗶𝘀𝘁𝗲𝗱 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 This Therapeutic Goods Administration guidance helps sponsors understand how to legally list low-risk medicines (AUST L and AUST L(A)) on the Australian Register of Therapeutic Goods (ARTG). 🔸Some changes may result in a new product classification, requiring a separate ARTG entry unless grouped under the “Groups Order.” 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #qualityassurance #regulatoryaffairs #pharmaceuticals To view or add a comment, sign in ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has declared two widely available medicines as spurious, directing provincial drug inspectors to immediately seize the affected products from markets across the country. According to a statement issued on Wednesday, the counterfeit medicines identified are Efaston tablets (Dydrogesterone 10mg) and Paracare suspension 60ml (Paracetamol 120mg/5ml). Laboratory analysis revealed that both products lack active pharmaceutical ingredients, rendering them ineffective and unsafe for public use. DRAP warned that such falsified drugs pose a serious threat to public health, potentially leading to treatment failure, worsening of illness, or life-threatening complications particularly for patients relying on them for essential therapies.
By adhering to these standards and guidelines, pharmaceutical companies. #pharmaregulatorycompliance# #pharmaqualityconyrolmeasures# #goodsmanufacturingpractices# #pharmanutraceuticals# To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US. To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. Previously, such tests were only required for raw materials, leaving finished syrups vulnerable to contamination. This regulatory change was prompted by a request from the Madhya Pradesh Food and Drugs Administration (MPFDA), which urged the inclusion of DEG and EG testing in the general monograph of the Indian Pharmacopoeia (IP).
In response, DCGI directed the Indian Pharmacopoeia Commission (IPC) to act immediately, leading to the issuance of ‘Amendment List-09’ to IP 2022. This amendment enforces mandatory DEG and EG testing for all oral liquid formulations, with permissible limits not exceeding 0.10%. The quantity must be measured using gas chromatography. The IPC also circulated the directive across India to relevant drug control authorities, laboratories, and pharmaceutical industry associations to ensure prompt implementation. This regulatory update addresses a critical loophole exposed by the repeated cough syrup-related deaths and aims to enhance drug safety and restore public trust in India's pharmaceutical regulatory framework. The authority has advised citizens to stop using these products immediately and to consult healthcare professionals if they experience any adverse effects. Consumers have also been urged to verify batch numbers before purchasing medicines and to report suspicious products to local health authorities.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 60mg | 180 + 10 Pills | 501.43€ 477.55€ | |
| Levitra Original | 20mg | 92 + 4 Pills | 406.22€ 386.88€ | |
| Levitra Generic | 40mg | 10 Pills | 41.37€ 39.40€ | |
| Levitra Soft Tabs | 20mg | 20 Pills | 74.68€ 71.12€ | |
| Levitra Original | 20mg | 76 + 4 Pills | 344.39€ 327.99€ | |
| Levitra Original | 20mg | 34 + 2 Pills | 188.51€ 179.53€ | |
| Levitra Generic | 20mg | 180 + 10 Pills | 293.10€ 279.14€ | |
| Levitra Generic | 20mg | 30 + 4 Pills | 70.59€ 67.23€ | |
| Levitra Original | 20mg | 48 + 4 Pills | 235.14€ 223.94€ | |
| Levitra Generic | 60mg | 10 Pills | 47.42€ 45.16€ | |
| Levitra Generic | 10mg | 360 + 10 Pills | 407.94€ 388.51€ | |
| Levitra Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Levitra Generic | 60mg | 90 + 6 Pills | 291.82€ 277.92€ | |
| Levitra Generic | 40mg | 90 + 6 Pills | 234.73€ 223.55€ | |
| Levitra Generic | 10mg | 20 Pills | 46.54€ 44.32€ | |
| Levitra Generic | 40mg | 360 + 10 Pills | 704.99€ 671.42€ |
In addition, pharmacies, hospitals, and healthcare providers have been instructed to monitor their supply chains closely and report any quality or safety concerns related to the two medicines to DRAP without delay.
#DRAP #HealthAlert #FakeMedicines #PublicWarning #Pakistan #PharmaSafety #DrugRegulation #Efaston #Paracare #CounterfeitDrugs To view or add a comment, sign in ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has declared two widely available medicines as spurious, directing provincial drug inspectors to immediately seize the affected products from markets across the country.
#AsiaRisk #Regulation #India To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. To view or add a comment, sign in Understanding the Key Differences and Recent Updates in DSUR, PBRER, and PSUR for Drug Safety Reporting As pharmacovigilance and drug safety professionals, it’s crucial to grasp the distinct roles and evolving regulatory expectations of the three main periodic safety reports: 1️⃣ Development Safety Update Report (DSUR): - Focused on investigational drugs in clinical trials - Includes cumulative safety summaries, clinical and nonclinical trial data, and risk-benefit assessments - Recent regulatory updates (e.g., UK Clinical Trial Regulation) aim to reduce administrative burden by removing detailed SAE/SAR listings and potentially exempting DSUR submissions to Research Ethics Committees - DSUR concentrates on evolving safety data to protect trial participants and inform development decisions 2️⃣ Periodic Benefit-Risk Evaluation Report (PBRER): - Applied to marketed drugs and ongoing studies - Advances beyond PSUR by integrating comprehensive benefit-risk analysis alongside cumulative safety and efficacy information - Covers extensive sections on safety signals, risk minimization, benefit evaluations, and integrated benefit-risk conclusions - Helps optimize therapeutic profiles with focus on maximizing benefits and minimizing risks in real-world use 3️⃣ Periodic Safety Update Report (PSUR): - Traditionally for marketed drugs, centered mainly on safety updates and regulatory status - Includes patient exposure, adverse event summaries, clinical and nonclinical data, and overall safety evaluations - Increasingly replaced by the PBRER format in many global regulatory jurisdictions to incorporate benefit evaluation.
#DRAP #HealthAlert #FakeMedicines #PublicWarning #Pakistan #PharmaSafety #DrugRegulation #Efaston #Paracare #CounterfeitDrugs To view or add a comment, sign in 🚨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞 - 𝐈𝐜𝐞𝐥𝐚𝐧𝐝: 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐒𝐚𝐟𝐞𝐭𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 (𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝟎𝟔 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟓) 📅 𝐏𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝: 06 October 2025 The Icelandic Medicines Agency (Lyfjastofnun) has published an updated Guidance on Safety Information on its official website, providing greater clarity on the dissemination and review of safety information in the Icelandic market. 𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 ✓ Clear definition of electronic distribution and what constitutes electronic prescription free levitra dissemination of safety information (Section: Dissemination of Safety Information) ✓ Clarification that safety information related to pharmaceutical forms not marketed in Iceland will not be assessed by the Icelandic Medicines Agency (Section: 1.6 Review by the Icelandic Medicines Agency and Dissemination of Safety Information) ✓ Aimed at strengthening regulatory transparency and consistency in safety information handling 𝐖𝐡𝐲 𝐈𝐭 𝐌𝐚𝐭𝐭𝐞𝐫𝐬 This update enhances efficiency and clarity in the regulatory process, ensuring streamlined communication and compliance for Marketing Authorization Holders (MAHs) operating within Iceland. It reinforces a transparent and harmonized approach to safety information management.
Quality Standards 1- GMP (Good Manufacturing Practice) A set of guidelines ensuring pharmaceutical products are manufactured, tested, and packaged in a controlled environment to meet quality standards. 2- ISO 9000 A series of quality management standards that help organizations ensure their products or services meet customer and regulatory requirements. Research Methodologies 1- Double-blind placebo-controlled studies A research design where participants are randomly assigned to treatment or placebo groups, and both participants and researchers are blinded to the treatment assignments. This design helps minimize bias and ensures the reliability of results. 2- Case trials studies Also known as clinical trials, these studies evaluate the safety and efficacy of new treatments or interventions in humans.
3- Black box symbol A warning label required by regulatory agencies, such levitra spray as the USFDA, to highlight serious or life-threatening risks associated with a particular medication. Intellectual Property and Standards 1- IP (Intellectual Property) Refers to patents, trademarks, copyrights, and trade secrets that protect innovations and creations in the pharmaceutical industry. 2- USP (United States Pharmacopeia) A non-profit organization that sets standards for the quality, purity, and identity of medicines, food ingredients, and dietary supplements. Journals and Publications 1- Peer-reviewed journals Scientific publications that publish research articles levitra professional for sale after rigorous review by experts in the field, ensuring the quality and validity of the research. 2-These regulatory bodies, quality standards, and research methodologies play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. 🌍 At Viginovix, we continuously monitor global pharmacovigilance and regulatory updates to help our partners uphold compliance, safety excellence, and readiness across all regions. 📩 info@viginovix.com & awanishpandey@viginovix.com 🌐 👉 What are your thoughts on how local regulatory clarifications contribute to global pharmacovigilance harmonization?
| Country | Legal Status | Prescription Requirement |
|---|---|---|
| USA | Prescription drug | Yes |
| UK | Prescription only medicine | Yes |
| Australia | Prescription-only medicine | Yes |
| Canada | Prescription drug | Yes |
#RegulatoryUpdate #Pharmacovigilance #DrugSafety #RegulatoryAffairs #Viginovix To view or add a comment, sign in 🚨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞 - 𝐈𝐜𝐞𝐥𝐚𝐧𝐝: 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐒𝐚𝐟𝐞𝐭𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 (𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝟎𝟔 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟓) 📅 𝐏𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝: 06 October 2025 The Icelandic Medicines Agency (Lyfjastofnun) has published an updated Guidance on Safety Information on its official website, providing greater clarity on the dissemination and review of safety information in the Icelandic market. To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US. USFDA approval is considered a gold standard for pharmaceutical products globally. 2- UK MHRA (Medicines and Healthcare products Regulatory Agency) Regulates medicines and medical devices in the UK, ensuring their safety, quality, and efficacy. 3- FSSAI (Food Safety and Standards Authority of India) Regulates food safety and standards in India, ensuring the quality and safety of food products.
Quality Standards 1- GMP (Good Manufacturing Practice) A set of guidelines ensuring pharmaceutical products are manufactured, tested, and packaged in a controlled environment to meet quality standards. 2- ISO 9000 A series of quality management standards that help organizations ensure their products or services meet customer and regulatory requirements. Research Methodologies 1- Double-blind placebo-controlled studies A research design where participants are randomly assigned to treatment or placebo groups, and both participants and researchers are blinded to the treatment assignments. This design helps minimize bias and ensures the reliability of results. 2- Case trials studies Also known as clinical trials, these studies evaluate the safety and efficacy of new treatments or interventions in humans. 3- Black box symbol A warning label required by regulatory agencies, such levitra spray as the USFDA, to highlight serious or life-threatening risks associated with a particular medication.
#DRAP #HealthAlert #FakeMedicines #PublicWarning #Pakistan #PharmaSafety #DrugRegulation #Efaston #Paracare #CounterfeitDrugs To view or add a comment, sign in 🚨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞 - 𝐈𝐜𝐞𝐥𝐚𝐧𝐝: 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐒𝐚𝐟𝐞𝐭𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 (𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝟎𝟔 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟓) 📅 𝐏𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝: 06 October 2025 The Icelandic Medicines Agency (Lyfjastofnun) has published an updated Guidance on Safety Information on its official website, providing greater clarity on the dissemination and review of safety information in the Icelandic market. 𝐊𝐞𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 ✓ Clear definition of electronic distribution and what constitutes electronic prescription free levitra dissemination of safety information (Section: Dissemination of Safety Information) ✓ Clarification that safety information related to pharmaceutical forms not marketed in Iceland will not be assessed by the Icelandic Medicines Agency (Section: 1.6 Review by the Icelandic Medicines Agency and Dissemination of Safety Information) ✓ Aimed at strengthening regulatory transparency and consistency in safety information handling 𝐖𝐡𝐲 𝐈𝐭 𝐌𝐚𝐭𝐭𝐞𝐫𝐬 This update enhances efficiency and clarity in the regulatory process, ensuring streamlined communication and compliance for Marketing Authorization Holders (MAHs) operating within Iceland. It reinforces a transparent and harmonized approach to safety information management. 🌍 At Viginovix, we continuously monitor global pharmacovigilance and regulatory updates to help our partners uphold compliance, safety excellence, and readiness across all regions. 📩 info@viginovix.com & awanishpandey@viginovix.com 🌐 👉 What are your thoughts on how local regulatory clarifications contribute to global pharmacovigilance harmonization?
#RegulatoryUpdate #Pharmacovigilance #DrugSafety #RegulatoryAffairs #Viginovix To view or add a comment, sign in 🚨 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐔𝐩𝐝𝐚𝐭𝐞 - 𝐈𝐜𝐞𝐥𝐚𝐧𝐝: 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐨𝐧 𝐒𝐚𝐟𝐞𝐭𝐲 𝐈𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 (𝐔𝐩𝐝𝐚𝐭𝐞𝐝 𝟎𝟔 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟓) 📅 𝐏𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝: 06 October 2025 The Icelandic Medicines Agency (Lyfjastofnun) has published an updated Guidance on Safety Information on its official website, providing greater clarity on the dissemination and review of safety information in the Icelandic market. To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US. USFDA approval is considered a gold standard for pharmaceutical products globally. 2- UK MHRA (Medicines and Healthcare products Regulatory Agency) Regulates medicines and medical devices in the UK, ensuring their safety, quality, and efficacy. 3- FSSAI (Food Safety and Standards Authority of India) Regulates food safety and standards in India, ensuring the quality and safety of food products. Intellectual Property and Standards 1- IP (Intellectual Property) Refers to patents, trademarks, copyrights, and trade secrets that protect innovations and creations in the pharmaceutical industry. 2- USP (United States Pharmacopeia) A non-profit organization that sets standards for the quality, purity, and identity of medicines, food ingredients, and dietary supplements. Journals and Publications 1- Peer-reviewed journals Scientific publications that publish research articles levitra professional for sale after rigorous review by experts in the field, ensuring the quality and validity of the research. 2-These regulatory bodies, quality standards, and research methodologies play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. By adhering to these standards and guidelines, pharmaceutical companies. #pharmaregulatorycompliance# #pharmaqualityconyrolmeasures# #goodsmanufacturingpractices# #pharmanutraceuticals# To view or add a comment, sign in Here's a comprehensive overview of the significance of various regulatory bodies, quality standards, and research methodologies in the pharmaceutical industry: Regulatory Bodies 1- USFDA (United States Food and Drug Administration) Ensures the safety and efficacy of drugs, biologics, and medical devices in the US. To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. Previously, such tests were only required for raw materials, leaving finished syrups vulnerable to contamination.
| Ingredient | Quantity per tablet | Function |
|---|---|---|
| Vardenafil | 20 mg | Active PDE5 inhibitor |
| Microcrystalline cellulose | - | Binder and filler |
| Lactose | - | Filler |
| Magnesium stearate | - | Lubricant |
| Hydroxypropyl methylcellulose | - | Coating agent |
| Titanium dioxide | - | White pigment for coating |
This regulatory change was prompted by a request from the Madhya Pradesh Food and Drugs Administration (MPFDA), which urged the inclusion of DEG and EG testing in the general monograph of the Indian Pharmacopoeia (IP). In response, DCGI directed the Indian Pharmacopoeia Commission (IPC) to act immediately, leading to the issuance of ‘Amendment List-09’ to IP 2022. This amendment enforces mandatory DEG and EG testing for all oral liquid formulations, with permissible limits not exceeding 0.10%. The quantity must be measured using gas chromatography.
The IPC also circulated the directive across India to relevant drug control authorities, laboratories, and pharmaceutical industry associations to ensure prompt implementation. This regulatory update addresses a critical loophole exposed by the repeated cough syrup-related deaths and aims to enhance drug safety and restore public trust in India's pharmaceutical regulatory framework. #AsiaRisk #Regulation #India To view or add a comment, sign in Drug regulator tightens safety norms after cough syrup deaths Following the death of 23 children in Madhya Pradesh due to consumption of Coldrif cough syrup contaminated with diethylene glycol (DEG), the Drugs Controller General of India (DCGI) mandated mandatory testing for both DEG and ethylene glycol (EG) in all raw materials and finished pharmaceutical products. To view or add a comment, sign in Understanding the Key Differences and Recent Updates in DSUR, PBRER, and PSUR for Drug Safety Reporting As pharmacovigilance and drug safety professionals, it’s crucial to grasp the distinct roles and evolving regulatory expectations of the three main periodic safety reports: 1️⃣ Development Safety Update Report (DSUR): - Focused on investigational drugs in clinical trials - Includes cumulative safety summaries, clinical and nonclinical trial data, and risk-benefit assessments - Recent regulatory updates (e.g., UK Clinical Trial Regulation) aim to reduce administrative burden by removing detailed SAE/SAR listings and potentially exempting DSUR submissions to Research Ethics Committees - DSUR concentrates on evolving safety data to protect trial participants and inform development decisions 2️⃣ Periodic Benefit-Risk Evaluation Report (PBRER): - Applied to marketed drugs and ongoing studies - Advances beyond PSUR by integrating comprehensive benefit-risk analysis alongside cumulative safety and efficacy information - Covers extensive sections on safety signals, risk minimization, benefit evaluations, and integrated benefit-risk conclusions - Helps optimize therapeutic profiles with focus on maximizing benefits and minimizing risks in real-world use 3️⃣ Periodic Safety Update Report (PSUR): - Traditionally for marketed drugs, centered mainly on safety updates and regulatory status - Includes patient exposure, adverse event summaries, clinical and nonclinical data, and overall safety evaluations - Increasingly replaced by the PBRER format in many global regulatory jurisdictions to incorporate benefit evaluation.
𝗠𝗮𝗸𝗶𝗻𝗴 𝗖𝗵𝗮𝗻𝗴𝗲𝘀 Sponsors may request changes to their ARTG entry to: 🔸Correct errors. 🔸Some changes may result in a new product classification, requiring a separate ARTG entry unless grouped under the “Groups Order.” 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #qualityassurance #regulatoryaffairs #pharmaceuticals To view or add a comment, sign in 📌𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗹𝗲𝗴𝗶𝘀𝗹𝗮𝘁𝗶𝘃𝗲 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 𝗳𝗼𝗿 𝗹𝗶𝘀𝘁𝗲𝗱 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗲𝘀 This Therapeutic Goods Administration guidance helps sponsors understand how to legally list low-risk medicines (AUST L and AUST L(A)) on the Australian Register of Therapeutic Goods (ARTG). 🔸Some changes may result in a new product classification, requiring a separate ARTG entry unless grouped under the “Groups Order.” 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #qualityassurance #regulatoryaffairs #pharmaceuticals To view or add a comment, sign in ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has declared two widely available medicines as spurious, directing provincial drug inspectors to immediately seize the affected products from markets across the country. According to a statement issued on Wednesday, the counterfeit medicines identified are Efaston tablets (Dydrogesterone 10mg) and Paracare suspension 60ml (Paracetamol 120mg/5ml). Laboratory analysis revealed that both products lack active pharmaceutical ingredients, rendering them ineffective and unsafe for public use.
DRAP warned that such falsified drugs pose a serious threat to public health, potentially leading to treatment failure, worsening of illness, or life-threatening complications particularly for patients relying on them for essential therapies. The authority has advised citizens to stop using these products immediately and to consult healthcare professionals if they experience any adverse effects. Consumers have also been urged to verify batch numbers before purchasing medicines and to report suspicious products to local health authorities. In addition, pharmacies, hospitals, and healthcare providers have been instructed to monitor their supply chains closely and report any quality or safety concerns related to the two medicines to DRAP without delay. #DRAP #HealthAlert #FakeMedicines #PublicWarning #Pakistan #PharmaSafety #DrugRegulation #Efaston #Paracare #CounterfeitDrugs To view or add a comment, sign in ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has declared two widely available medicines as spurious, directing provincial drug inspectors to immediately seize the affected products from markets across the country.