Market Access Today’s Post

Government and PSK Collaborate to Strengthen Pharmacy Reforms and Local Manufacturing In a significant move to improve healthcare services and boost local pharmaceutical manufacturing, the government of Kenya, through the Ministry of Health, has joined forces with the Pharmaceutical Society of Kenya (PSK). This collaboration aims to advance key pharmacy reforms and strengthen the country’s ability to produce medicines domestically. The Principal Secretary for Public Health #HealthcarePolicy #LocalManufacturing #pharmacyreforms #PSK

Government and PSK Collaborate to Strengthen Pharmacy Reforms and Local Manufacturing In a significant move to improve healthcare services and boost local pharmaceutical manufacturing, the government of Kenya, through the Ministry of Health, has joined forces with the Pharmaceutical Society of Kenya (PSK). This collaboration aims to advance key pharmacy reforms and strengthen the country’s ability to produce medicines domestically. The Principal Secretary for Public Health #HealthcarePolicy #LocalManufacturing #pharmacyreforms #PSK

The European Medicines Agency has unveiled an updated timetable for Post-Authorisation Measures concerning Advanced Therapy Medicinal Products, signaling a significant advancement in regulatory oversight. This refined schedule, overseen by the Pharmacovigilance Risk Assessment Committee, aims to enhance the monitoring of safety and efficacy for medicinal products after authorization. Covering stages from submission deadlines to final adoption by the Committee for Medicinal Products for Human Use, the timetable introduces a structured and transparent process for interventional and non-interventional protocols, progress reports, and cumulative reviews. By promoting precise coordination and clear timelines, the European Medicines Agency is striving to reduce submission errors, prevent delays, and maintain a sharp focus on patient safety. This initiative represents a proactive stride toward optimizing the lifecycle management of European Medicines Agency, ensuring pharmaceutical companies and healthcare professionals can navigate regulatory pathways with enhanced efficiency. A vital update for all stakeholders committed to advancing medicinal product supervision and safeguarding public health across Europe. 🚀🩺🔬 #AdvancedTherapies #EuropeanMedicinesAgency #HealthcareInnovation #HealthcarePolicyandRegulation #LifeCycleManagement #MedicinalProducts #PatientSafety #Pharmaceuticals #Pharmacovigilance #RegulatoryAffairs #RegulatoryAgencies #MarketAccess #MarketAccessToday

⏳ Timely Reviews in Pharmaceuticals: A Critical Pillar for Public Health ⏳ Regulatory agencies and pharmaceutical companies are intensifying efforts to enhance the efficiency and accuracy of medicine approvals and monitoring. Central to this process are the Periodic Safety Update Reports and Single Assessments for Advanced Therapy Medicinal Products—key instruments that ensure the safety and efficacy of therapies in the market. The European Medicines Agency recently introduced a revised schedule emphasizing the importance of meeting submission deadlines to prevent review delays that could jeopardize patient access to vital European Medicines Agency. Key takeaways: ✅ Strict adherence to submission deadlines safeguards the entire regulatory process. ✅ Early and precise eCTD submissions ensure seamless evaluations. ✅ Understanding and navigating the updated schedules helps avoid technical pitfalls and invalid applications. With regulatory timelines carefully calibrated to reflect evolving safety standards and scientific progress, pharmaceutical professionals must engage deeply with these frameworks. Meeting these critical milestones is not only a legal obligation but a commitment to advancing patient safety and innovation in healthcare. #AdvancedTherapies #EuropeanMedicinesAgency #HealthcareInnovation #HealthcarePolicyandRegulation #MedicinesApproval #PatientSafety #PharmaCompliance #PharmaceuticalRegulation #PublicHealth #RegulatoryAgencies #RegulatoryScience #TimelySubmissions #MarketAccess #MarketAccessToday

The Medicines and Healthcare products Regulatory Agency, Advertising Standards Authority and General Pharmaceutical Council (GPhC) have taken action again against the advertising of prescription-only medicines used for weight management. https://lnkd.in/eqv3kvFX #healthcare #medicines #weightloss #mhra #patientsafety

⭐ Pharmacy professionals are leaders in safe and effective use of medicines. This includes understanding the regulations, such as advertising, that underpin safe medication use. 😔 It is really disappointing that General Pharmaceutical Council (GPhC) are having to take action in a few cases where a minority of pharmacy professionals are not leading, but are 'following' the crowd to lowering professional standards.

Transforming local pharmaceutical systems is crucial for ensuring universal access to essential European Medicines Agency. New research highlights the often-overlooked role of local pharmaceutical systems, emphasizing their unique functions in governance, supply management, financing, resource development, dispensing, and performance monitoring. By developing a robust and innovative framework, experts provide a practical tool to evaluate and improve these systems, ensuring European Medicines Agency are not only accessible but used appropriately for better healthcare outcomes. This breakthrough underscores the necessity of coordinated local efforts and comprehensive analysis to empower policymakers and healthcare providers alike. As we advance, adopting this structured methodology offers a strategic pathway to enhance medicine access and optimize healthcare delivery on the ground. 🔬💊📈 #AccessToMedicine #HealthPolicy #HealthcareInnovation #HealthcareTransformation #LocalHealthSystems #MedicineAccess #PharmaceuticalSystems #Publications #RegulatoryAgencies #UniversalHealthCoverage #MarketAccess #MarketAccessToday

Government and PSK Collaborate to Strengthen Pharmacy Reforms and Local Manufacturing In a significant move to improve healthcare services and boost local pharmaceutical manufacturing, the government of Kenya, through the Ministry of Health, has joined forces... #Health #HealthcarePolicy #LocalManufacturing #pharmacyreforms #PSK https://lnkd.in/dhbqEmeh

📣 📣 📣 The European Medicines Agency (EMA) has announced new guidelines from the European Commission that simplify the process for updating approved medicines in the EU. This "Variations Regulation" aims to make the system faster and more efficient for both pharmaceutical companies and regulators, ensuring patients benefit from scientific advances more quickly. 💡 Purpose:  To streamline the management of changes to medicines after they are approved (their lifecycle) 💡Main Benefit:  Quicker and more efficient processing of changes, benefiting both drug companies (Marketing Authorisation Holders) and regulators. 💡Effective Date:  The new rules apply to variation applications submitted from January 15, 2026. Background on Variations ◾ Why Variations Exist: Companies must continuously update their marketing authorisation to reflect new scientific knowledge about a medicine's quality, safety, and efficacy. ◾ Risk-Based Classification: Type IA: Minor changes (e.g., change of company address). Type IB: Minor changes requiring notification (e.g., agreed safety updates). Type II: Major changes requiring approval (e.g., a new indication for the medicine). ◾ Goal of the System: To ensure that any change made to a medicine after approval maintains its positive benefit-risk balance for patients. #EMA #VariationsGuidelines #LifecycleManagement #ECRegulations #CPHIFrankfurt #PharmaceuticalIndustry #MedicineMarketingAuthorisation https://lnkd.in/eFCTP7KS

📣 📣 📣 The European Medicines Agency (EMA) has announced new guidelines from the European Commission that simplify the process for updating approved medicines in the EU. This "Variations Regulation" aims to make the system faster and more efficient for both pharmaceutical companies and regulators, ensuring patients benefit from scientific advances more quickly. 💡 Purpose:  To streamline the management of changes to medicines after they are approved (their lifecycle) 💡Main Benefit:  Quicker and more efficient processing of changes, benefiting both drug companies (Marketing Authorisation Holders) and regulators. 💡Effective Date:  The new rules apply to variation applications submitted from January 15, 2026. Background on Variations ◾ Why Variations Exist: Companies must continuously update their marketing authorisation to reflect new scientific knowledge about a medicine's quality, safety, and efficacy. ◾ Risk-Based Classification: Type IA: Minor changes (e.g., change of company address). Type IB: Minor changes requiring notification (e.g., agreed safety updates). Type II: Major changes requiring approval (e.g., a new indication for the medicine). ◾ Goal of the System: To ensure that any change made to a medicine after approval maintains its positive benefit-risk balance for patients. #EMA #VariationsGuidelines #LifecycleManagement #ECRegulations #CPHIFrankfurt #PharmaceuticalIndustry #MedicineMarketingAuthorisation