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National Drug Authority (NDA)
(http://www.nda.or.ug/page.php?k=abthistory)
Mandate
The National Drug Authority (NDA) was established in 1993 by the National Drug
Policy and Authority Statute which in 2000 became the National Drug Policy and
Authority (NDP/A) Act, Cap. 206 of the Laws of Uganda (2000 Edition). The Act
established a National Drug Policy and National Drug Authority to ensure the
availability, at all times, of essential, efficacious and cost-effective drugs to the
entire population of Uganda as a means of providing satisfactory healthcare and
safeguarding the appropriate use of drugs.
Vision
A world class drug regulatory agency effectively protecting and promoting public
health.
Mission Statement
To ensure access to quality, safe and efficacious human and veterinary
medicines and other healthcare products through the regulation and control of
their production, importation, distribution and use.
Core values
In pursuing and fulfilling the vision and mission, NDA achieves personal,
organisational and public good by:
Caring for the People of Uganda
We advance the public good with purpose and passion while honouring
democratic values:
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To preserve and improve human health and life by ensuring that the best
interests of the population always prevail over those of the clients.
Ensuring that the clients' services satisfy population needs and benefit
humanity.
We responsibly and wisely manage resources entrusted to us.
Taking Pride in What We Do
We are motivated and guided by our personal integrity:
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Maintaining the high standards required by national and international
regulations.
Committed to the highest standards of ethics and integrity.
Dedicated to the highest level of scientific excellence and commit our
operations to improving human and animal health and the quality of life.
Building a Workplace Community
We respect each other and work together in a healthy environment:
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We embrace diversity and nurture empowering relationships.
We recognise that the ability to excel, to most competitively meet society's
and customers' needs depends on the integrity, knowledge, imagination,
skill, diversity and teamwork of our employees. We value these qualities
most highly.
Provide awareness on controversial and new therapeutic approaches in
the wider context of the practice of medicine where ethical issues arise, for
example unlicensed products and counterfeits.
By being accountable for our values and their integration in our work, we lay the
foundation for excellence at NDA.
The Functions of the Drug Authority
The functions of the Drug Authority are stated under Section 5 of the NDP/A Act,
Cap. 206. These are:
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deal with the development and regulation of the pharmacies and drugs in
the country;
control the importation, exportation and sale of pharmaceuticals;
control the quality of drugs;
promote and control local production of essential drugs;
encourage research and development of herbal medicines;
establish and revise professional guidelines and disseminate information
to the health professionals and the public;
provide advice and guidance to the Minister and bodies concerned with
drugs on the implementation of the National Drug Policy; and
perform any other function that is connected with the above or that may be
accorded to it by law.
Governance Structure
NDA's Board consists of the chairperson and the following other persons:
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the Director of Medical Services;
the Commissioner for Veterinary Services;
the Commissioner for Trade;
the Director, Criminal Investigation Department;
the Chief of Medical Services, Ministry of Defence;
the Chief of Pharmaceuticals and Health Supplies;
the Head of the Natural Chemotherapeutics Laboratory;
the Director, Mulago Hospital;
A representative of each of the following:
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the National Medical Stores;
the Uganda Medical Association;
the Pharmaceutical Society of Uganda;
the Uganda Veterinary Association;
the Head of the School of Pharmacy, Makerere University;
the Uganda Herbalists;
the Uganda Dental Association;
the Joint Medical Store;
the Director General of the Uganda AIDS Commission;
two other persons appointed from the public.
Management Structure
The Drug Authority Secretariat is headed by the Executive Director with nine
departments namely; Drug Assessment and Registration, Drug Inspectorate
Services, Drug Information, Quality Control, Quality Management, Finance,
Human Resource and Administration, Legal Services and Internal Audit. In
addition to the departments, there are three units that report directly to the
Executive Secretary/Registrar namely; Public Relations, Information Technology,
and Procurement. The Food Desk that was established to handle the regulatory
framework of food safety reports to the Executive Secretary/Registrar.
The Drug Inspectorate Services Department ensures that all medicines
manufactured locally and imported into the country are of good quality and are
properly handled. The department ensures that drugs are inspected at all major
ports of entry to minimise entry of sub-standard and counterfeit drugs into
Uganda. Inspection and licensing of all pharmaceutical handling facilities has
also been adequately catered for. Activities have been developed to rid the
country of illegal operators of drug outlets and substandard and counterfeit drugs
through intensifying support supervision and post marketing surveillance. In this
Strategic Plan, Zonal Inspectors will be recruited and reasonably facilitated to
provide backup to the regional inspectors in ensuring that there is more NDA
presence on the ground. Staff training and development, considered critical to
the success of the department and adequate provision, has been provided for it
in the Strategic Plan.
The Drug Assessment and Registration Department ensures that all
medicines registered in Uganda meet national and internationally accepted
quality, safety and efficacy standards. Emphasis has been put in developing the
capacity of the department in evaluating dossiers, amendments to the dossiers
and maintaining an accurate medicines register. Staff training, especially in
handling emerging areas like public health products, herbal medicines,
biologicals and vaccines, has also been catered for in the Plan. Sensitisation of
stakeholders regarding the registration of herbal medicines and other emerging
areas is also addressed.
The Quality Control Department at the National Drug Quality Control
Laboratory (NDQCL) conducts quality control testing of samples of medicines,
medical devices and public health products (e.g. long lasting insecticides treated
nets (LLINs). Focus is put on strengthening the capacity of the laboratory to
widen the range of samples tested and to establish facilities for microbiological
testing of drug samples. Construction of an extension to NDQCL started in
October 2010 and when completed, it will provide suitable and additional space
for the provision of microbiological and medical devices testing, storage of
chemicals and controlled laboratory documentation. As part of the strategy to
achieve international recognition, the laboratory is in the process of establishing
and implementing a quality management system to achieve WHO
prequalification for the medicine testing and ISO/IEC 17025 accreditation for the
medical device testing.
The Drug Information Department ensures that all stakeholders,
pharmaceutical service providers and the general public receive the right
information on medicines. The department also ensures that drug promotional
materials are vetted, approved and monitored to ensure that misleading, biased
and inaccurate information on medicines is not disseminated. The department is
also responsible for pharmacovigilance programs, adverse drug reactions
reporting and clinical trials monitoring. The department hosts the National
Pharmacovigilance Centre.
The Finance Department is responsible for providing financial and management
accounting information for statutory reporting, decision making and control of the
financial activities of the Drug Authority. The department will, among others,
focus on:
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Strengthening financial management systems, practices, controls, and
reporting to ensure financial accountability, meeting statutory and
regulatory requirements, and providing timely, reliable, and useful financial
information.
Ensuring vigorous oversight of the financial reporting process to sustain a
culture of honesty and high ethical standards.
Participating in resource mobilisation through project proposal writing and
lobbying the Government and development partners in a bid to improve
NDA's income base.
Implementing timely, collaborative, and transparent financial planning
process that ensures most effective allocation of limited resources to
support the NDA's mission.
The Human Resource and Administration Department as the custodian of the
most important resource, human resources, is committed to ensure that
employees are adequately empowered to undertake their work. It has also
ensured that annual staff appraisals, staff development and reward systems have
been adequately catered for in the Human Resource Manual. NDA is developing
a ten-year infrastructure development plan 2010-2020. This plan will contain
detailed information regarding infrastructure development needs for the proposed
construction of the Secretariat office building, laboratory building, seven NDA
regional office buildings; and procurement of furniture and equipment,
information and communication technology software and hardware systems,
motor vehicles, ten acres of land for the Secretariat and laboratory buildings and
seven acres of land for the seven NDA regional office buildings. The plan
assumes that NDA would fully take on the mandate for the regulation and control
of food safety in Uganda and hence the transformation of the NDA into NFDA.
The Legal Services Department is responsible for providing the necessary legal
advice to NDA. The department shall also foster closer cooperation with other
law enforcement agencies to sensitise them on the Act to enable enforcement of
the provisions of the NDP/A Act.
The Internal Audit Department ensures that internal controls, systems and risk
management procedures are appropriate and functioning properly. It also
ensures that there is compliance with existing policies, regulations and
procedures in the management of assets and liabilities.
The Quality Management Department ensures that the systems and processes
and their interaction throughout the entire NDA are established and documented.
The department is responsible for the quality management system
documentation (guidelines, manuals, protocols, standard operating procedures
(SOPs), specifications, checklists, aide memoires, charts, job descriptions, forms,
records, etc.) necessary to ensure the effective planning, operation and control of
NDA processes. This results in efficient and effective operations which are a prerequisite for meeting customer as well as statutory and regulatory requirements.
The department is also responsible for organising internal and external quality
audits and liaise with certification, accreditation, prequalification and other
conformity assessment bodies/agencies.
Quality management systems underscore the importance of customer focus,
leadership, involvement of people, process approach, systems approach to
management, continual Improvement, factual approach to decision making, and
mutual beneficial supplier relationships. It is evident that the implementation of a
quality management system will provide the following benefits to NDA:
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Service delivery improvement in terms of effectiveness and efficiency,
Confidence among internal and external customers due to competence
building,
Predictability through accountability and transparency of operations,
Reliability through use of sustainable and robust systems and processes,
Acceptability of NDA services nationally, regionally and internationally,
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Customer satisfaction, i.e. satisfaction of staff, clients, the public, the
Government, development partners, UN organisations, etc.
The implementation of a quality management system is, therefore, highly
essential for the effective functioning of NDA and efficient service delivery.
The Information Technology Unit facilitates NDA in its operations and plans
are underway to widen it to incorporate Management Information Systems (MIS).
This includes messaging, file sharing and Internet services. The Authority has
repositioned itself to be more competitive, efficient and customer-oriented,
through use of Information Technology. This is being done through enhancement
of the infrastructure upon which these services run with a view of achieving
higher throughput, higher reliability and better user experience. NDA's strategy is
to have a secure ICT infrastructure that is able to deliver current, comprehensive
and accurate information and technology solutions in a user-friendly and reliable
medium to the Drug Authority and NDA Management for the policy and decision
making process; to the staff for effective processing of their work; to other
stakeholders for their information needs for effective service delivery. The NDA
strategy is to establish technology-assisted knowledge and experience sharing
mechanisms so as to reduce the duplication of effort and increase opportunities.
The Public Relations Unit has the primary responsibility of promoting NDA's
corporate image by informing, sensitising, enlightening and creating awareness
on the role of the Drug Authority to the public. In carrying out these functions the
unit engages the services of the mass media and the information channels of
communication as effective tools in the discharge of its duties. The unit in
collaboration with other units and departments, is responsible for the
development of information, education and communication materials (e.g.
quarterly newsletters, information leaflets), medium of communication (electronic
or print) and promotional wear of the Drug Authority. It also co-ordinates outreach
and community relation programs of the Drug Authority with respective
stakeholders and the public.
The Procurement Unit ensures that goods, services and works are
transparently procured in compliance with Public Procurement and Disposal of
Public Assets (PPDA) Act and Regulations.
The Food Desk is responsible for handling the transformation of NDA into a
National Food & Drug Authority (NFDA) in order to widen its regulatory scope to
include regulation of food, food supplements and other substances used in public
health that are not explicitly provided for under the NDP&A Act.