Impact of System Medicines in Registration Regulatory Management
Explore the experience shared by Dr. Shani Maboko from Tanzania Food & Drugs Authority at the East Africa Health Scientific Conference. The focus is on the importance of Medicines Registration Establishment (MRE) processes in ensuring quality, safety, and efficacy of medicines, highlighting the use of sophisticated data management tools and electronic application processes.
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Presentation Transcript
THE 7THEAST AFRICA HEALTH SCIENTIFIC CONFERENCE 27THTO 29THMARCH, 2019 THE INFORMATION EXPERIENCE FROM TANZANIA FOOD AND DRUGS AUTHORITY IMPACT OF SYSTEM MEDICINES IN REGISTRATION REGULATORY MANAGEMENT DECISION MAKING: Dr. Shani M. Maboko Drug Registration Officer Tanzania Food & Drugs Authority www.tfda.go.tz
Outline Background Study objectives Methodology Results Conclusion Acknowledgement www.tfda.go.tz
Background MRE is critical in ensuring that medicines in our market meet acceptable levels of quality, safety and efficacy. TFDA has been implementing MIS systems since 2004 Initial system: Regsoft MIS IMIS from 2014; sophisticated data management tool with links to other regulatory modules such as GMP, I & E Has been expanded to cater for other areas of MA (query responses, promotional materials) www.tfda.go.tz
Objective To streamline MRE processes thus increasing efficiency and ultimately ensuring quality, safety and efficacy of medicines: Receive all applications electronically Ensuring proper payment Process applications from receiving to granting Safe storage of application data Tracking progress of applications Ensure accountability of regulators Ease of roles and responsibility of MRE section (updating registers, monthly reports) www.tfda.go.tz
Methodology MRE system development Developed based on requirements of users (registration officers) SOPs Guidelines and Regulations Registration data from 2013/14 up to 2017/18 was analysed; Registration module Stages of evaluation: new applications submitted in 2017/18 were followed from referencing to granting Performance reports Monitoring and evaluation www.tfda.go.tz
Cont.. Revenue reports Retention fees collected from 2014 2016 were analysed www.tfda.go.tz
Results The overall registration system is fully operational and is in line with relevant Regulations, SOPs and guidelines. Referencing Invoicing Accounting Receiving Review (TC) Data entry Evaluation Auditing Granting www.tfda.go.tz
Results cont... Tracking of timelines and progression of applications can be done www.tfda.go.tz
Results cont.. Automatic processes: Notification of Applicants once the application has passed receiving and granting Update of live register of registered medicines which is publicly available through www.tfda.go.tz Change of status for products that have expired and hence blocking importation Flagging of fees defaulters www.tfda.go.tz
Results cont... Increase in revenue collection www.tfda.go.tz
Conclusion and recommendations The system was instrumental in attainment of WHO ML3 as it has improved management of applications for registration as well as collection of revenue for the Authority www.tfda.go.tz
Acknowledgements TFDA Management Team TFDA Manager for ICT and Statistics www.tfda.go.tz
Thank you (Asante) Mt. Kilimanjaro www.tfda.go.tz
