Dr. Delese Mimi Darko holds a Doctorate Degree in Pharmacology and a Bachelor of Pharmacy from the Kwame Nkrumah University of Science and Technology (KNUST),and a master’s degree in Business Administration from the University of Northampton.
With her over 32-years of experience in the field of food and medical products regulation; specifically, starting from product testing in the laboratory after which she moved to head the marketing authorization, post approval safety monitoring of medicines and clinical trials functions. Mimi was instrumental in the designation of the FDA as a Regional Center of Regulatory Excellence in 3 critical areas, namely: Medicines Safety (pharmacovigilance); Clinical Trials Oversight and Drug Registration by the NEPAD/African Medicines Regulation Harmonization (AMRH) in 2014.
Mimi rose through the ranks at the Food and Drugs Authority (FDA) to the position of a Deputy Chief Executive Officer before her appointment in 2017 as Chief Executive Officer, the first staff of FDA to occupy this position. Under her leadership, the FDA has experienced tremendous improvement in its regulatory system for both food and medical products.
In 2020 the FDA achieved WHO Maturity Level 3 for medicines and vaccines (non-producing) and is therefore considered as to operate a stable, well-functioning and well-integrated regulatory system. In 2022 the Drugs Laboratory achieved WHO Maturity Level 4 and was awarded WHO-Prequalified Quality Control Laboratory status, making it the first laboratory in West/Central Africa to achieve such a feat. She continues to inspire the FDA towards achieving WHO Maturity Level 4 for medicines and vaccine (producing).
She was instrumental in the approval of the Food Safety Policy which is currently being implemented to safeguard the safety of the food supply chain from farm to fork, by promoting collaboration amongst the multiple government agencies within the food control system in Ghana. At its launch in 2022, a Food Emergency Response Plan was also established to coordinate a national response to food safety emergencies to safeguard public health in Ghana. By this achievement she has contributed immensely to building a strong foundation for food safety in Ghana.
Mimi has ensured the FDA maintains a strong quality management system to drive consistency and continuous improvement in service delivery by the FDA. In this light, the FDA has consistently maintained its ISO9001:2015 certification for its operational and technical functions under her strong leadership. The FDA’s Centre for Laboratory Service and Research (CLSR) also continues to expand its scope of ISO/IEC 17025:2017 accredited tests which currently stands at 58 tests, and for the first time, in 2022 the Food Laboratory was accredited for five (5) tests by the American National Accreditation Board (ANAB). This gives the CLSR the accolade as the laboratory with the largest scope of accredited tests under one-roof in Africa.
Her contribution towards the growth of the FDA as an organization has been phenomenal. In response to changes in the regulatory landscape, she led the rebranding of FDA, positioning it as a consumer and client focused organization that has brought a refreshing appeal to its stakeholders and made the FDA a household name. As part of her plans to bring FDA services closer to our consumers and clients, three (3) new offices comprising one regional office in Western North Region and two district offices in the Central Region were opened in 2022, with several more to be opened in 2023.
Mimi has implemented a new organogram for FDA to reflect the emerging needs of the organization and its stakeholders. The key highlight of this organogram is an Enforcement Directorate that leverages on intelligence to drive investigations and ensure efficiency and effectiveness in enforcement activities; and the Business Development and International Partnerships Directorate that harnesses the resources of partners and funding agencies to strengthen the regulatory systems at the FDA and to provide technical assistance and training to other regulatory agencies in Africa.
She is leading the FDA to play a key role in making Ghana a vaccine manufacturing country.
The FDA has introduced many innovations including: the progressive licensing scheme, in collaboration with the Ghana Enterprise Agency (GEA), for Cottage and Small-Scale businesses to ensure compliance with safety and quality standards; a decentralized system for food product evaluation across all regions using an online evaluation platform that has reduced registration time from three months to six weeks; the establishment of a traceability system for agro produce in trade to aid the timely implementation of regulatory decisions; and requirements for labeling genetically modified foods, feed and regulations for the agro produce industry in retail, transportation and distribution among others.
Mimi chairs the WHO African Vaccines Regulatory Forum (AVAREF) Steering Committee and serves on several international and local advisory committees and bodies.
Her exemplary and commendable work has earned her several awards. Notable amongst them are: Outstanding Female Leadership Award under Ghana Pharma Awards 2023, the President of Ghana’s Order of the Volta Companion Award 2023, the Exemplary Leadership Award under the Ghana-West Africa Healthcare Excellence Awards 2022, Best CEO of the year under the Ghana Medical Laboratory Excellence Awards 2022, the Public Sector Chief Executive Officer award under the African Public Sector Awards in 2022, United Nations (UN) Inter-Agency Task Force (UNIATF) award on the Prevention and Control of Non-Communicable Diseases in New York, the 2019 GLiTZ Africa’s award for Ghana Women of the Year Honors (Excellence in Health), Ghana Business Standard Awards for the Female Business Leader of the Year in 2019 and the Advertising Association of Ghana Special Recognition award for her role in regulating the advertisement of FDA regulated products.
Mimi is a devout Christian and is married with two children.
· Now we’ve built local manufacturing – is it sustainable?
· Are these decentralized manufacturing hubs working and is the infrastructure also in place to support it?
· How will African producers start matching the multinational manufacturers in production? The role of international and national collaborations
· The need for regulatory strengthening and infrastructure
· How do we ensure vaccine acceptability and uptake of vaccines manufactured from Africa?