Emer Cooke’s Post

EMA UPDATE – Fee Regulation working arrangements. From January 1st, 2025, the European Medicines Agency (EMA) is introducing new fees that will affect Marketing Authorisation Holders (MAHs) and they have just released a new document laying out the working arrangements for this.   The new fees are applicable for both procedure-based pharmacovigilance activities such as the assessments of periodic safety update reports (PSURs) and post-authorisation-safety-study (PASS) protocols and study results, and annual fee activities supporting ongoing legislation, literature monitoring and Eudravigilance development. More information from the EMA is available here: https://lnkd.in/dAy6assq Information about our pharmacovigilance solutions: https://lnkd.in/gjAusNrF Information about our LITSIS advanced Literature Monitoring platform here: https://lnkd.in/gDJRDzj6 Please share this post to spread the news and help Delta PV keep growing. Delta PV creates lean, efficient, and effective pharmacovigilance and safety solutions across Europe, CIS, EAEU, Africa, MENA, and APAC. See how we can support you at www.deltapv.com #EMA #MAH #Pharmacovigilance 

EMA UPDATE: From January 1st, 2025, EMA is implementing new fees impacting Marketing Authorisation Holders, covering pharmacovigilance activities such as PSURs and PASS protocols, as well as ongoing support for legislation, literature monitoring, and Eudravigilance. MAHs must now navigate updated working arrangements outlined in the latest EMA document. Stay informed to ensure compliance and operational readiness in pharmacovigilance. #Pharmacovigilance #EMAUpdate #RegulatoryCompliance

The Regulatory Affairs Networking Cocktail Theme: The World Health Organization Global Benchmarking Tool Assessment of National Medicines Regulatory Authorities (NMRAs) and its Role in Pharmaceutical Systems Strengthening. Access to safe, quality and efficacious medicines for all in the African continent is still a vision awaiting realization. The health security of Africa is still challenged by diseases which can be prevented or treated with timely access to appropriate and affordable medicines, vaccines and other health services, yet stringent regulatory policies present challenges to access to medicines. In response to regulatory challenges, a number of regional harmonization efforts have been introduced by African Union through the African Medicines Regulatory Harmonization (AMRH) initiative. We also acknowledge the use of the WHO global benchmarking tool (GBT), a primary means by which WHO assesses regulatory systems for the regulation of medical products. Drawing from this, we have curated the Regulatory Affairs Networking Cocktail, where stakeholders come together for the purpose of working together towards a common goal, how can more African NMRAs adopt and benefit from the use of the WHO GBT? Join us on August 9, 2024 at The Concord Hotels, Beach Villas, and Game Lodges for an engaging & enlightening Networking Cocktail. Register: https://lnkd.in/dGPbnD_j #PharmaceuticalSystemsStrengthening

Zimbabwe becomes the sixth country in Africa to reach WHO maturity level 3 in regulation of medicines Following formal assessment by WHO, Zimbabwe has achieved maturity level 3 (ML 3) in WHO’s classification of regulatory authorities for regulation of medicines. The WHO assessment of regulatory authorities is based on the Global Benchmarking Tool, which checks regulatory functions against a set of more than 260 indicators beginning with ML1 describing the existence of some elements of a regulatory system. Maturity level 3 confirms a stable, well-functioning and integrated regulatory system is in place. The highest level, maturity level 4, is achieved by a regulatory system operating at an advanced level of performance and with continuous improvement. The benchmarking of the National Regulatory System of Zimbabwe, represented by the Medicines Control Authority of Zimbabwe (MCAZ) and other relevant regulatory institutions of Zimbabwe, was first conducted in 2021 and finalized in May 2024 in close collaboration with the WHO Regional Office for Africa. “This is an important step forward by Zimbabwe, which reflects commitment to strengthening health systems and regulatory frameworks to increase access to quality medicines and medical supplies, and to help accelerate progress towards universal health coverage,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. WHO’S global benchmarking is part of the WHO programme for regulatory system strengthening and covers core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 are considered eligible for inclusion among WHO-listed Authorities, after additional evaluation of their performance. “This represents a significant milestone for Zimbabwe, as MCAZ has reached the level of a regulatory system operating as a stable, well-functioning and integrated regulatory system for medicine regulation,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “This achievement is the result of investment by the Government of Zimbabwe in the strengthening of its regulatory system and will also contribute to future operationalization of the African Medicine Agency (AMA).” #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #regulatoryscience #regulation #ICH #Zimbabwe #globalregulatoryaffairs https://lnkd.in/gG8EYAVV

The Regulatory Affairs Networking Cocktail Theme: The World Health Organization Global Benchmarking Tool Assessment of National Medicines Regulatory Authorities (NMRAs) and its Role in Pharmaceutical Systems Strengthening. Access to safe, quality and efficacious medicines for all in the African continent is still a vision awaiting realization. The health security of Africa is still challenged by diseases which can be prevented or treated with timely access to appropriate and affordable medicines, vaccines and other health services, yet stringent regulatory policies present challenges to access to medicines. In response to regulatory challenges, a number of regional harmonization efforts have been introduced by African Union through the African Medicines Regulatory Harmonization (AMRH) initiative. We also acknowledge the use of the WHO global benchmarking tool (GBT), a primary means by which WHO assesses regulatory systems for the regulation of medical products. Drawing from this, we have curated the Regulatory Affairs Networking Cocktail, where stakeholders come together for the purpose of working together towards a common goal, how can more African NMRAs adopt and benefit from the use of the WHO GBT? Join us on August 9, 2024 at The Concord Hotels, Beach Villas, and Game Lodges for an engaging & enlightening Networking Cocktail. Register: https://lnkd.in/dGPbnD_j #PharmaceuticalSystemsStrengthening

‼️EMA : European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure This guidance document addresses a number of questions which users of the #centralisedprocedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are typically addressed during the course of #presubmissionmeetings. It will be updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication. The #EMA emphasises the importance of pre-submission meetings between applicants and the EMA/(Co)Rapporteur. Pre-submission meetings (which should take place approximately 7 months prior to the anticipated date of submission of the application) are a vital opportunity for applicants to obtain procedural, #regulatory and legal advice from the EMA. The product team is available to address any questions MAHs may have regarding their pre-authorisation application. This guidance information and fruitful pre-submission meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-submission meetings will also enable applicants to establish contact with the EMA staff closely involved with the application as it proceeds. ➡️ Note: It should be highlighted that this document has been produced for guidance only and should be read in conjunction with "The rules governing medicinal products in the European Union”, Volume 2A, Notice to Applicants. Applicants must in all cases comply with all requirements of Union Legislation. Provisions, which extend to EEA countries (i.e. the EU member states, plus Norway, Iceland and Liechtenstein) by virtue of the EEA agreement, are outlined in the relevant sections of the text. If you like this post follow me on LinkedIn

Access to safe, effective, quality diagnostics, therapeutics and vaccines is a critical benchmark to measure the quality healthcare of any given populace. Regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products and timely access to patients when needed. Within the African context; lack of access to quality, safe, efficacious and affordable medical products have posed a significant challenge to public health for countries, in part, this is attributed to weak or absent policies and regulatory systems. The WHO GBT assessment tool has plays a critical role in ensuring NMRAs identify their areas of strength as well as areas for improvement and build effective and resilient systems by implementing functional Institutional Development Plans (IDPs). During the Regulatory Affairs Networking Cocktail we will be delving into a this much needed discussion on The World Health Organization (WHO) GBT Assessment for NMRAs and its Role in Pharmaceutical Systems Strengthening in Africa. So far African countries have benefited from this intervention but what more does this mean for the health status in Africa. Register: https://lnkd.in/dA2niCC8 Date: August 9, 2024 Venue: The Concord Hotels, Beach Villas, and Game Lodges , Nairobi, Kenya. #PharmaceuticalSystemsStrengthening #TheWHOGBTAssessment

📣📣📣For the attention of colleagues in pharma industry, as you know leaders on our continent are working hard to open the doors of one of the most strategic public health institution for the people of Africa - The African Medicines Agency. They can't do it all on their own however. This part needs your contribution and participation. So please step forward to help us stress test the processes that our African Medicines Agency is developing serve the people of Africa. African Medicines Regulatory Harmonisation (AMRH) initiative is announcing the launch of a phase 1 of the pilot of the continental procedure on evaluation of medicinal products through its Evaluation of Medicinal Products Technical Committee (EMP-TC) supported by the continental technical committee on Good Manufacturing Practices (GMP-TC) All applications and other supporting documents for the purpose of this pilot should be submitted to the South African Health Product Regulatory Authority (SAHPRA) which has been selected by the AUDA NEPAD to receive, process, and manage the application dossiers during the pilot phase. If evaluation demonstrates that a product and its corresponding manufacturing and clinical site(s) meet the continental standards acceptable by the Technical Committees (i.e., internationally acceptable standards), the medicinal product will be issued with an INDEPENDENT SCIENTIFIC OPINION or RECOMMENDATION which will then allow the product to be included in the continental list (listing) of medicinal products recommended by the EMP-TC (if positive). The assessment as well as inspection reports will be shared with concerned National Regulatory Agencies (NRAs) in Africa to support and facilitate registration and marketing authorization of Africa’s priority medicinal products Send the EOI to the following mailbox addresses: [email protected] [email protected] [email protected] #africa #health #healthcare #medicines #vaccines #publichealth #pharma

The maturity of medicine regulations in Tanzania reflects a progressive approach to safeguarding public health and ensuring the quality, safety, and efficacy of pharmaceutical products. As Tanzania continues to enhance its regulatory framework under the oversight of the Tanzania Food and Drugs Authority (TFDA), it demonstrates a commitment to meeting international standards and addressing the evolving needs of its healthcare system. This maturation process underscores Tanzania's dedication to fostering a robust pharmaceutical sector that prioritizes patient well-being and contributes to overall healthcare advancements in the region. #medicine #vaccinedevelopment #famasidawa #africamedecine.

The African continent has five national medicines regulatory agencies that have attained maturity level 3 either for vaccines or medicines on the WHO benchmarking tool (GBT). This means that they have achieved a stable, well-functioning, and integrated regulatory system capable of effective oversight and quality assurance for the specific area. The GBT is a tool designed to evaluate the overarching regulatory framework and the component regulatory functions (e.g. Clinical Trial Oversight, Marketing Authorization, Vigilance, Laboratory Testing,  Licensing Inspection, Marketing Surveillance and Control, Regulatory Inspection, and National Regulatory System ) through about 268 sub-indicators that may also be grouped and examined according to nine cross-cutting categories or themes, for example, quality and risk management system, Processes, Human Resources, etc. The GBT also incorporates the concept of ‘maturity level’ or ML (adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 (existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement). Medicines for Africa has prepared a summary map of African nations at ML3 and their areas of maturity. #africa #health #healthcare #medicines #vaccines #publichealth #counterfeitedmedicines #substandardmedicines #leniashwenda