TMDA Management Team
Section 11 (4) of the Tanzania Medicines and Medical Devices Act, Cap 219 provides for establishment of the Management Team to advise the Director General on functions and management of TMDA. Based on the current structure and functions, the composition of TMDA Management Team is as follows:
Director General (DG) – Chairman
The Office of Director General is under Mr. Adam Mitangu Fimbo.
Mr. Adam Mitangu Fimbo is currently a PhD candidate at Karolinska Institutet – Sweden. He also holds a Masters Degree in Clinical Trials which he attained at the University of London at London School of Hygiene and Tropical Medicine – United Kingdom. Likewise, he also acquired a Masters Degree in Pharmaceutical Services and Medicines Control of the University of Bradford in United Kingdom. His first degree was Bachelor of Pharmacy which he did at Muhimbili University of Health and Allied Sciences (MUHAS).
Read MoreMr. Fimbo is the Director General of TMDA – the position he is holding since September 2020. Before that he was in the acting capacity since 2018. Between 2010 and 2018, Mr. Fimbo was the Director of Medicines and Cosmetics at the time the Tanzania Food and Drugs Authority (TFDA) was in existence.
Mr. Fimbo has pioneered the establishment of an effective regulatory system within TMDA that has enabled the Authority to become one of the best Authorities in Africa including attaining ISO 9001 certification and World Health Organization (WHO) Maturity Level 3. He has further orchestrated the development of a robust and effective system for control of clinical trials in Tanzania which was inexistent before 2008.
Mr. Fimbo was part of a team that pioneered the establishment of the African Vaccines Regulators Forum (AVAREF) whose objectives are centred around building capacity of African regulatory authorities and ethics committees to set-up systems for regulatory oversight of clinical trials involving HIV, malaria, meningitis, rotavirus, ebola and other priority vaccines.
Coupled with his managerial acumen, Mr. Fimbo conversely possesses great technical abilities in a wide array of regulatory functions to include assessment of dossiers of medicines, vaccines, medical devices and diagnostics submitted by manufacturers for marketing authorization, good manufacturing practices (GMP) inspection of pharmaceutical, biological and medical device manufacturers, good clinical practices (GCP) inspection of clinical trials, pharmacovigilance expertise including monitoring of adverse events following immunization (AEFIs) and auditing of quality systems in organizations as per ISO standards. The work experience and knowledge acquired through his qualifications have contributed significantly towards accruing these notable and holistic technical abilities.
Mr. Fimbo has also attended a series of national, regional and international meetings, workshops and seminars related to regulation of medical products including making presentations. He had also been engaged in a number of retreats to develop various regulatory guidelines that are currently in use.
As the Director within TMDA, Mr. Fimbo had saved as the Secretary in a number of Committees to include the Human Medicines Registration Technical Committee, the Veterinary Medicines Registration Technical Committee, the Clinical Trials Technical Committee, the Pharmacovigilance Technical Committee and the Medical Devices and Diagnostics Registration Technical Committee. He was also the Chairman of the Tender Board, Chairman of the Staff Loan Committee and Chairman of the Integrity Committee.
In the international arena, Mr. Fimbo had worked as the Technical Officer with the World Health Organization (WHO) in Geneva – Switzerland under the auspices of the WHO Prequalification Programme, between November 2008 and February 2009. In the same Programme context, he was amongst the Assessors who were commissioned by the WHO in the assessment of dossiers for products that seek WHO prequalification approval between 2007 and 2009.
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Director of Business Support (DBS) – Secretary
The Directorate of Business Support is under Mr. Chrispin Mesiaki Severe.
Mr. Severe is a registered Pharmacist who graduated from Muhimbili University of Health and Allied Sciences (MUHAS) in 2002. He holds a Master of Business Administration (MBA) majoring in Service Marketing from the University of Dar es Salaam; Post Graduate Diploma in Medicines Management in International Health and a Diploma in Development Journalism from InWent Capacity Building Institute, Germany and the Indian Institute of Mass Communication, respectively.
He has worked with the Authority for over 18 years and accrued vast experience in pharma and regulatory functions. He has attended several managerial and technical training, seminars, workshops and meetings within and outside the country.
Read MorePrior to this post, Mr. Severe served in several managerial, technical and support positions with the Tanzania Food and Drugs Authority (TFDA) between 2003 and 2016, including Manager for Public Education and Drug Information Section as well as Pharmacovigilance and Drug Information Officer. He coordinated the development of relevant communication strategies under the formative research on community awareness about the importance of salt iodization. The study was funded by the United Nations Children Fund (UNICEF).
He has also participated in the development of a Regional Communication and Advocacy strategic plan for promoting the rational use and safety of medicines in the East African Community (EAC) partner states and presided over the development and operationalization of Institutional five years Strategic Plans and Annual Work-plans and budgets. The existing TMDA’s SP (2017/18 – 2021/22) has seven (7) strategic objectives which are periodically monitored and annually evaluated under the coordination of Mr. Severe.
He has been involved in the evaluation of applications for marketing authorization; good manufacturing practice (GMP) inspection of domestic and foreign pharmaceutical manufacturing facilities as well as inspection of medicines outlets; execution of pharmacovigilance activities; coordination of Adverse Drug Reactions (ADRs) reporting and assessment including development and publication of the TMDA’s Newsletters.
Mr. Severe served as a Chairperson of TMDA’s Technical Committee on Post Marketing Surveillance (PMS) program; a member of the regulated products business Premises Registration Technical Committee and the Authority’s Editorial Committee between August 2006 and June 2018.
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Director of Human and Veterinary Medicines (DMC) – Member
The Directorate of Human and Veterinary Medicines is under Dr. Yonah Hebron Mwalwisi.
He is a pharmacist with a Doctor of Philosophy Degree (PhD). Dr. Mwalwisi studied for his Bachelor of Pharmacy degree at the Muhimbili University and Allied Sciences (MUHAS) way back in 1998; his Masters of Science degree in Pharmaceutical Analysis from Strathclyde University, Glasgow, Scotland in 2004; and a Doctor of Philosophy Degree (PhD) from St. Julius Maximilians’ Wurzburg University in Wurzburg, Germany in 2017. He has worked in medicines regulation for over 20 years now, starting with the Pharmacy Board in 1998 – 2002; Tanzania Food and Drugs Authority (TFDA) 2003 – 2019; and currently, the Tanzania Medicines and Medical Devices Authority where he serves in the role of the Director for Director of Human and Veterinary Medicines (DMC) of the Tanzania Medicines and Medical Devices Authority (TMDA) from 1st March 2021 to date.
Read MoreAs a Director for Medicines Product Control, Dr. Mwalwisi is responsible for managing the resources of the directorate and providing executive leadership on medicines registration, variations, and control of regulated product promotional materials; approves and regulates clinical trials; coordinates inspection, law enforcement, licensing, and registration of premises including GMP inspection of local and overseas manufacturing premises of regulated products; post-marketing surveillance and vigilance of medicines; develop and maintain good relations with customers; control the importation of narcotics and psychotropic substances; execute programs, and research related to the directorate functions; and foster cooperation with regional and international bodies on matters pertaining to the directorate.
He served as a lab manager for the medicines chemical testing section from 1st March 2008 to February 2021. It was under his leadership that the laboratory became prequalified by the World Health Organization (WHO) in January 2011 and maintained that status throughout his leadership.
He has authored and co-authored over 11 publications, attended several short courses related to medicines regulation; inspected over 100 pharmaceutical manufacturing facilities within and outside Tanzania; and served as a member of various technical committees related to pharmaceutical regulations. He is currently a secretary to all technical committees of medicinal products under the directorate.
He also participated in designing and executing several medicines quality surveillance programs organized by WHO in the region such as the Quality of Antimalarial Medicines in Sub-Saharan Saharan Africa (QAMSA) in 2009. In 2000 - 2003, he was involved in the designing, implementation, and coordination of a program that established a network of Accredited Drug Dispensing Outlets (ADDO) famously known as Duka la Dawa Muhimu in rural and peri-urban areas, where pharmaceutical services were poorly developed, and the public experienced a shortage of both basic and essential medicines.
He pioneered the establishment of the medicines quality assurance program in 2002 whereby samples of medicines are collected at ports of entry and tested by using the GPHF Minilab kit.
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Director of Laboratory Services (DLS) – Member
The Directorate of Laboratory Services is under Dr. Danstan Hipolite Shewiyo.
He is a Pharmacist by profession, who graduated from Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzanian 1995/96. He holds a Master degree in Pharmaceutical Sciences majoring in Drug Analysis and Quality Control from Ghent University, Belgium (1999) and attained his PhD in Pharmaceutical Science with a research on Analytical Methods Development and Validation from Free University of Brussels, Belgium, in 2012.
He was employed by the Pharmacy Board of Tanzania in June, 2000. Pharmacy Board was the transformed to Tanzania Food and Drugs Authority (TFDA) in 2003 and he continued to serve as an analyst until 2008 when he became the Head of Technical Support Department and later, he became the Manager for Technical Support in the Directorate of Laboratory Services. He was part of the team that made TFDA Quality Control Laboratory to be WHO prequalified on 17 January, 2011. Read More
In January 2017 he became Acting Director of Laboratory Services at TFDA and he was confirmed on the position in January, 2018. TFDA was later changed to Tanzania Medicines and Medical Devices Authority (TMDA) in July, 2019, and he continued to serve on the same post. He is the current Chairman of the Tender Board of TMDA.
Apart from being an analyst, he has also developed a career in quality assurance areas especially working on ood Manufacturing Practices (GMP), Good laboratory Practices (GLP), Good Clinical Practices (GCP) and ISO/IEC 17025 standards. He has conducted more than 40 GMP inspections on medicines manufacturing facilities locally and abroad as well as clinical trial inspections. He is also an ISO 17025 auditor.
He has over 15 publications in peer–reviewed journals and two (2) book chapters in scientific books. He has participated in developing and validating several analytical methods for quality control of medicinal and food products. Dr, Shewiyo is currently a honorary lecturer at the School of Pharmacy at MUHAS, where he teaches undergraduate and post graduate students on GMP and Quality Assurance subjects; and a part-time lecturer at St. John University of Tanzania, in Dodoma, where he teaches Pharmaceutical Analysis.
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Director of Medical Devices and Diagnostics Control (DMD) – Member
The Directorate of Medical Devices and Diagnostics Control is under Ms. Kissa W. Mwamwitwa.
Ms. Kissa Mwamwitwa is a registered Pharmacist who is currently a PhD candidate at Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania. She holds a Master’s Degree in Pharmaceutical Sciences from the University of Gent, Belgium (2003) and a Bachelor Degree of Pharmacy from MUHAS acquired in 1998.
As a Director for Medical Devices and Diagnostics Control, Ms Mwamwitwa is responsible for managing resources of the directorate and providing executive leadership on Medical devices and In vitro Diagnostics registration, variations and control of regulated products’ promotional materials; coordinate inspection, law enforcement, licensing and registration of premises including quality audits of local and overseas products manufacturing premises. She is also responsible for managing post-marketing surveillance and vigilance of medical devices and in-vitro diagnostics; developing and maintaining good relations with customers; controlling importation and research related to the directorate functions; and fostering cooperation with regional and international bodies on matters pertaining to the medical devices and in-vitro diagnostics regulations.
Read MoreMs. Mwamwitwa has more than 20 years of working experience in the pharmaceutical area, having strong expertise in Medicine Regulatory Systems. She possesses great technical abilities in a wide range of regulatory functions including assessment of medicines dossiers, vaccines, medical devices and diagnostics submitted by manufacturers for marketing authorization; good manufacturing practices (GMP) inspection of pharmaceutical; good clinical practices (GCP) inspection of clinical trials; vigilance expertise to include medicines and vaccines safety monitoring, and conducted various post-marketing surveillance (PMS) survey.
Prior to this post, Ms. Mwamwitwa served as a Manager of Clinical Trials Control and Pharmacovigilance between July 2014 and January 2022, where she participated in strengthening systems of clinical trials, vigilance and Post Marketing Surveillance for TMDA. She also was involved in the benchmarking process conducted at TMDA (previously Tanzania Food and Drugs Authority - TFDA) in areas of clinical trials control, pharmacovigilance and post marketing surveillance and enabled the Authority to attain World Health Organisation (WHO) Maturity Level 3.
She was involved in different research project development and implementation to strengthen regulatory systems especially for safety, efficacy and quality monitoring of medical products in Tanzania. She has been coordinating four (4) projects funded by European and Developing Countries Clinical Trials Partnership (EDCTP) namely SMERT, PROFORMA, PAVIA and ASCEND, and participated in other two (2) projects funded by WHO and Commonwealth Partnership Scheme (CwPAMS).
Ms. Mwamwitwa has over eight (8) publications in peer–reviewed journals and is also a trainer in the Regional Centre of Regulation Excellence in Medicines Evaluation and Registration – East African Community (RCORE) at MUHAS in areas of Clinical Trials Control, Post-marketing Surveillance, and Pharmacovigilance. She is also a member of Advisory Board of the safety in pregnancy Bill and Melinda Gates funded project and has been participating in conducting WHO benchmarking exercise in different countries using Global Benchmarking Tools (GBT).
She has attended a series of national, regional and international meetings, training, workshops and seminars including making presentations with regards to her field of expertise. She had also been engaged in developing various regulatory working tools such as regulations, guidelines, manuals, checklist, and standard operation procedures (SOPs) that are useful within and outside Tanzania.
Before joining TMDA in 2004, she was employed by Ministry of Health since June 2000 and stationed at the Muhimbili School of Pharmacy (Institute of Allied Health Science) as a lecturer in different pharmacy subjects. She also has experiences in working with hospital and community pharmacies, where she worked with Muhimbili National Hospital, Aghakhan Hospital and C.N Community Pharmacy between 1999 and 2000.
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Ag. Manager - Legal Services (MLS)
The Legal Services Unit is under Adv. Martha Malle.
Martha S. Malle, is a lawyer by profession, Advocate of the High Court of Tanzania with Postgraduate Diploma in Law (PGDL) from University of Dar es Salaam and Bachelor degree in Laws (LLB) from University of Dar es Salaam. Currently, she is Acting Manager of Legal Services. Her main responsibilities include overseeing all legal matters within TMDA, advising Director General on legal issues, coordinating police case fillings, supervision prosecution and litigation measures at Court of Laws across the country and linking up with the Director of Public Prosecution (DPP) on prosecution and other related legal matters. She is also responsible for networking and cooperation with State Attorneys in the office of Attorney General who assist TMDA on enforcement of the law. Ms. Malle also serves as part of the Secretariat of the TMDA Board assisting the Secretary of the Board who is the Director General.
Manager – Communication and Public Education (MCPE)
The Communication and Public Education Unit is under Ms. Gaudensia Simwanza.
Ms. Simwanza holds Masters degree in Business Administration majoring in Marketing (MBA Marketing) from the University of Dar es Salaam. She attained her Bachelor degree in Mass Communication (BAM-hons) from St. Augustine University of Tanzania. She is the current Manager of Communication and Public Education whose core function is to discharge all communication and public education matters for and on behalf of TMDA.
Manager – Information Communication Technology and Statistics (ICT)
The Information Communication Technology and Statistics Unit is under Mr. Ambele Mwafula.
Mr. Mwafula holds Masters of Science in Computer Science from the University of Dar es Salaam, Tanzania, majoring in Software Development Projects. He attained his Bachelor degree in Computer Science (majoring in Computer Programming) at the University of Dar es Salaam, Tanzania.
Ag. Manager – Procurement Management
The Procurement Management Unit is under Ms. Donatha B. Koko.
Ms. Koko holds a Masters degree of Science in Procurement and Supply Chain Management from Mzumbe University. She is a Procurement Specialist Registered with the Procurement and Supplies Professionals and Technician Board (PSPTB), a Certified Procurement and Supplies Professionals. (CPSP)
Chief Accountant
The Unit of Finance and Accounting is under CPA. Adam John Kimetelo.
CPA. Kimetelo is an accountant as Certified Public Accountant is currently pursuing Masters of Business Administration at the Open University of Tanzania. He is a holder of Advanced Diploma in Certified Accountancy (ADCA), from IDM Mzumbe, currently Mzumbe University. Chief Accountant whose core function is to discharge with all finance and accounts matters for and on behalf of TMDA.
Chief Internal Auditor
The Unit of Internal Audit is under CPA. Godian Ngamesha.
CPA. Ngamesha is currently pursuing a Masters of Business Administration (MBA) at ESAMI. He is a holder of Advanced Diploma in Accountancy (ADA), a Certified Public Accountant (CPA) and Certified Fraud Examiner (CFE) by Professional. He is the current Acting Manager Internal Audit Unit whose core duties are to provide objective assurance and consulting services to the Authority on the areas of governance processes, risk management and controls.
Manager Quality and Risk Management
The Unit of Quality and Risk Management is under Ms Grace Mng’ong’o Shimwela .
Ms Grace Mng’ong’o Shimwela is the Manager for Quality and Risk Management at TMDA, Certified ISO 9001 Lead Auditor, Drug Inspector and Good Manufacturing Practices (GMP) Inspector for the medical products manufacturing facilities. She holds a Bachelor of Pharmacy Degree from the University of Dar es salaam (UDSM) and Master of Science Degree in Pharmaceutical Management from Muhimbili University of Health and Allied Sciences (MUHAS). Ms Shimwela also pursued a Master Degree in Business Administration from Eastern and Southern African Management Institute (ESAMI) majoring in Corporate Governance. She has more than 20 years’ experience in pharmaceutical field and regulatory systems, worked with Tanzania Medicines and Medical Devices Authority (formally Pharmacy Board and later Tanzania Food and Drugs Authority) since 2002. Throughout her tenure, she has served various positions, including Head of Premises Registration and Licensing (2005 - 2008), Medicines and Cosmetics Post Marketing Surveillance and Counterfeit Coordinating Officer (2009 - 2015), Manager for Cosmetics and Complementary Medicines Registration (2015 - 2018) and Manager for Medical Devices, Diagnostics and Cosmetics Control (2018 - 2019).
Read MoreAs Manager for Quality and Risk Management, Ms Shimwela is responsible for managing resources of the unit, coordinating and monitoring implementation and maintenance of quality management system throughout TMDA, coordinating efforts for developing and enhancing appropriate risk management policies, system and procedures, and participating in the inspections and quality audits according to relevant field. She has attended several trainings, workshops and seminars including making presentation related to medical products regulations, quality management and risk management at national, regional and internal levels; inspected over 100 medical products manufacturing facilities within and outside Tanzania; and served as a member of various technical committees related to medical products regulations. She is currently serving technical committees for GMP inspection, risk management, and ICT steering at TMDA. She has also participated in developing various policies related to medical products regulatory system, regulations, guidelines, standard operating procedures and other documentation useful within and outside Tanzania.
CloseClick here to view the current TMDA Organizational Structure.