The Sunday News
Background
The Medicines Control Authority of Zimbabwe (MCAZ) is the national medicines and healthcare products regulatory authority in Zimbabwe. It was first established in 1969 as the Drugs Control Council. The MCAZ is the successor to the Drugs Control Council and the Zimbabwe Regional Medicines Control Laboratory in 1997 through an Act of Parliament, the Medicines and Allied Substances Control Act (MASCA) (Chapter 15.03).
Under the MASCA Cap 15:03, the legislated responsibilities of the MCAZ are;
1. Processing of applications for registration and marketing (and subsequent change notifications, variations) in Zimbabwe of medicines and healthcare products that fall under the purview of the Act,
2. Licensing of premises and persons responsible for the manufacture, supply, distribution, and storage of medicines,
3. Approval of clinical trials of the medicinal products under the scope of the Act,
4. Collection and evaluation of reports of adverse reactions/events to medicinal products.
5. Official testing and release of batches of medicinal products within the scope of products under the Act.
6. Inspections in connection with the approval of clinical trial applications, the processing of medicines registration applications compliance with current Good Manufacturing Practices (cGMP).
The aim and objective of all these measures is to guarantee the quality, efficacy and safety of the medicinal products within the scope of the MCAZ, according to the latest standards prevailing in science and technology, and thus to contribute to the availability of medicinal products with a positive benefit/risk assessment in Zimbabwe.
Vision
Our vision as the MCAZ is to be an effective medicines regulator in Zimbabwe and a leading regulatory authority in the world. The strategic focus for the current five-year period 2014-2018 has been to become a Regional Centre of Regulatory Excellence (RCORE) in Sadc and in Sub-Saharan Africa.
Mission
Our mission is to protect public and animal health by ensuring that accessible medicines and medical devices are safe, effective and of good quality, through enforcement of adherence to standards by manufacturers and distributors.
Core Values
The following constitute the core values for MCAZ:
Customer-focus, integrity, accountability and continuous improvement.
MCAZ MOTTO / CREDO
“Protecting your right to quality medicines and medical devices”
A look back at 2014
The major milestones achieved by the Authority in its pursuit for establishing robust management systems was the WHO Prequalification of the Chemistry Laboratory. This status reinforces the already existing ISO/IEC 17025 accreditation status issued by the South African National Accreditation System (SANAS). In addition the MCAZ was also accorded the status of NEPAD Regional Centre of Excellence (RCORE) for Medicine Registration and Evaluation, Quality Control and Quality Assurance of Medicines and Medical Devices, and Oversight of Clinical Trials (jointly with the Medical Research Council of Zimbabwe) as well as pharmacovigillance and pharmacoepidemiology in conjunction with the World Health Organisation (WHO)-Uppsala Monitoring Centre (UMC) Collaborating Centre for Africa at the University of Ghana.
The MCAZ actively shapes the medicines and healthcare products regulatory environment through involvement at regional and international level. This is achieved through participation in technical expert committees and working groups that set policy and standards at the Sadc, AU and WHO levels. Further, MCAZ staff diligently contribute to the WHO Pre-qualification of Medicines Programme (PQP) in assessing and evaluating medicines submitted for WHO pre-qualification. In the area of vaccine regulation, MCAZ through its staff participates in strengthening vaccine regulation in other regulatory authorities on the African continent.
The above accolades show that MCAZ has successfully adopted internationally recognised systems and standards for registration and quality testing of medicines and medical devices and for control of clinical trials and pharmacovigillance of medicines. The MCAZ employees have the same critical competences as their counterparts in well-resourced countries. The MCAZ’s expertise is well respected throughout Africa. To the Zimbabwean patients that use registered medicines, gloves and condoms, they can rest assured that the internationally recognised regulator, MCAZ, has meticulously reviewed and authorised those products for use.
Even though it may not be very obvious to the general public MCAZ is a key contributor to the improvement of the national public health and animal health agendas. The decline in new HIV infections is attributable to the multiple interventions by the Ministry of Health and Child Care, the National Aids Council, the development partners and other players. MCAZ’s role of ensuring that Zimbabweans have access to condoms that conform to internationally accepted quality standards, is key input into the totality of interventions to avoid the spread of HIV.
MCAZ conducts quality testing of ARVs, anti-TBs, anti-malarial medicines that are imported into the country by government and its development partners UNDP, and Unicef, as well as humanitarian non-governmental organisations. The presence of a strong regulator as MCAZ in the country deters counterfeiters from shipping fake ARVs, antimalarial, anti-TB into the country as is known to happen in poorly resourced and poorly regulated markets.
On the international arena, MCAZ as a RCORE, can offer training of personnel from other upcoming regulatory bodies. MCAZ laboratories can now conduct contract testing of medicines procured by UN agencies (UNDP Global Fund and Unicef) for their programmes for supply of quality assured medicines to Zimbabwe and other countries that lack WHO prequalified laboratories.
. . . and for the future
In the next ten years MCAZ will retain our WHO Prequalification status, our ISO 17025 Accreditation, and our RCORE status and acquire any new best practices that become important for custodians of patient safety, like ourselves.
Some of our priority areas include the following:
i. Hosting fellowship and training programmes for other regulatory bodies in Sadc, Sub-Saharan Africa and beyond.
ii. Becoming part of the Pharmaceutical Inspectorate Co-operation (PICs) where we become part of a network of National Medicines and Healthcare Products Regulatory Authorities that share and exchange information on Good Manufacturing Practices (GMP) inspection of medicines manufacturers is another key priority.
iii. Having robust Management Information Systems (MIS) including portals for electronic submission of e-CTD dossiers, online tracking of progress of registration process for our applicants.
iv. Publishing public assessment reports for Health practitioners and patients in Zimbabwe, as well as other Regulatory Authorities that consider outcomes of MCAZ evaluation of medicines for their own registration processes.
v. Continued joint assessments and joint inspections, information sharing and exchange with the Zambia-Zimbabwe-Botswana-Namibia (ZaZiBoNa) collaboration, as well with other Sadc countries.
vi. Ensuring that Zimbabwe pharmaceutical Industry keeps pace with modern trends in pharmaceutical product manufacturing.
The story behind our success…
The Authority’s new strategic plan using Result Based Management (RBM) is in line with Government`s directive for Parastatals and State Enterprise to adopt RBM as part of its initiatives to stimulate sustainable growth through implementation of the Country`s economic blueprint Zim Asset. As an organisation our strategic priorities can change with the changes in the environment but our values of customer-focus, integrity, accountability and continuous improvement endure. A culture of excellence permeates our Board, Technical Committees, Management and staff. We all have different roles to play but our collective focus stays on ensuring quality, safety and efficacy of medicines for the Zimbabwe public.
To succeed we keep on learning new and better ways of delivering existing and new value-added regulatory services to the industry and quality assured medicines and medical devices for the patient. We learn from our successes, from our failures, from our critics, from other regulators, from WHO, from local and international stakeholders.
Our success is a story of good relationships with our principal the Ministry of Health and Child Care (MoHCC) who supports us in maintaining a robust regulatory framework, our Board and technical committees that provide strategic direction, oversight and governance, our staff that strive to do more and better every day, our customers that demand efficiency and better services, and last but not least the Zimbabwean patient who deserve nothing less than the highest possible standard of quality, safety and efficacy of medicines and medical device.
Perhaps our success story is our ability to live the spirit and letter of our mandate and our ability to connect with our values, with our customers, stakeholders and the patient.
