Background
Challenge | Proposed Strategy | No. | Recommendation | Recommendation Typea |
---|---|---|---|---|
Implement value-added regulatory practices that utilize available resources | Advance and leverage convergence and reliance initiatives | 1 | Document and communicate current reliance and convergence efforts and develop supporting infrastructure and tools to facilitate implementation | Analytics |
2 | Strengthen capacity building networks | Collaboration | ||
Institutionalize sustainability | 3 | Define needed capacities in NRAs using the WHO global benchmarking tool | Analytics | |
4 | Establish stable and transparent financing mechanisms | System development | ||
Utilize risk-based approaches for resource allocation | 5 | Perform risk analysis and implement risk management | Workforce development | |
6 | Develop systems to monitor and evaluate the impact of risk-based approaches for resource allocation | Analytics | ||
Timely access to new quality-assured medical products without compromising safety and efficacy | Strengthen registration efficiency and timeliness | 7 | Establish and refine value-added registration processes, resources, and systems | System development Collaboration |
8 | Build value-added technical capacity of assessors | Workforce development | ||
Strengthen inspection capacity and effectiveness | 9 | Enhance information sharing and use and reliance on existing inspection resources | Collaboration | |
10 | Build capacity of multi-disciplinary teams of inspectors | Workforce development | ||
Limited evidence-based data to support post-marketing regulatory action | Develop and implement risk-based post-marketing quality surveillance systems | 11 | Establish recognition of the value for risk-based post-marketing quality surveillance throughout the supply chain | System development |
12 | Develop and implement risk-based post-marketing quality surveillance programs, supporting tools, and communication strategies | Analytics Workforce development | ||
Strengthen regulatory management of manufacturing variations | 13 | Develop and implement risk-based programs to incorporate post-marketing manufacturing variations into marketing authorizations | Analytics System development |
Methods
Country (NRA) | Structure | Funding Source(s) | Comments |
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Argentina (Administración Nacional de Medicamentos Alimentos y Tecnología) | Autonomous | Government funds | Administratively and financially independent but user fees go to central funding; decision-making is independent. |
Australia (Therapeutic Goods Administration) | Autonomous | User fees | Regulatory decisions are made by delegates of the Ministry of Health (TGA employees) |
Ethiopia (Food and Medicine and Health Care Administration and Control Authority) | Semi-autonomous | Government funds User fees | Under Department of Health but reports to Parliament |
Ghana (Food and Drugs Authority) | Operationally autonomous (not financially) | Government funds User fees | Does not sit under the Ministry of Health; independent agency that reports to the Minister |
India (Drug Controller General of India, Drug Control Authority) | Semi-autonomous, under Ministry of Health | Government funds | Minimal user fees, which are unsustainable and provided to the Ministry |
Indonesia (Badan Pengawas Obat dan Makanan) | Ministry level institution | Government funds | Minimal user fees; head of BPOM is a minister-level position, reports to President |
Lao People’s Democratic Republic (Food and Drug Department) | Not autonomous, under Ministry of Health | Government funds Donors | |
Netherlands (Medicines Evaluation Board) | Autonomous | User fees | Regulatory decisions are independent of Ministry |
Pakistan (Drug Regulatory Authority Pakistan) | Autonomous | Government funds User fees | Under Ministry of Health but independent in its decision-making; minimal government funding (~ 2%) |
Papua New Guinea (Pharmaceutical Service Standards Branch) | Not autonomous, under Department of Health | Government funds | Fees are returned to Treasury |
Singapore (Health Sciences Authoritya) | Autonomous, under Ministry of Health | Government funds User fees | Statutory board under Ministry of Health, autonomy in decision-making |
South Africa (South African Health Products Regulatory Authority) | Autonomous, under the Department of Health | Government funds User fees | Independent public entity that retains revenue generated, employs its own staff, and is accountable to Parliament |
United States of America (Food and Drug Administration) | Autonomous, under Department of Health and Human Services | Government funds User fees | Fee proportions varies by centers; decisions made almost exclusively by civil servants in FDA (delegated decision-making by law and regulation) |
Zimbabwe (Medicines Control Authority of Zimbabwe) | Autonomous, not under Ministry of Health | User fees | Not under Ministry of Health, but Minister is responsible for actions |
Implement value-added regulatory practices that utilize available resources
Advance and leverage convergence and reliance initiatives
Document and communicate current reliance and convergence efforts and develop supporting infrastructure and tools to facilitate implementation
Strengthen capacity building networks
Institutionalize sustainability
Define needed capacities in NRAs using the WHO global benchmarking tool
Establish stable and transparent financing mechanisms
Due to a policy shift, in 1997, several Zimbabwean government entities, including MCAZ, were given the ability to run their operations by utilizing revenue generated through the provision of services. Since this change, MCAZ has performed several financial analyses and exercises to balance the need to cover the cost of service provision and the need to enable market entry for both domestic and international manufacturers. Equally important to obtaining the legal authority to independently run its operations was the work MCAZ undertook to develop the infrastructure and processes required to operationalize this new process: establishing the necessary financial procedures, developing standard operating procedures, and hiring and training an internal finance, accounting, and operations team.
Because MCAZ are funded through generated fees, senior leadership also quickly recognized that a risk-based approach would be the only way to regulate effectively, balancing the need to sustain activities with the criticality of protecting patient safety. An example of this can be seen in how the organization has approached the regulation of medical devices. While MCAZ has had the mandate to regulate medical devices since its inception, the Authority decided to roll out this regulation based on risk, which dictated an initial focus on male condoms in 2005 and medical gloves in 2006 because of the prevalence of HIV/AIDS at the time. With the recent publication of WHO’s model guidelines on the regulation of medical devices [29], MCAZ is again displaying its responsiveness by starting to regulate the import and export of additional medical devices as part of an initial risk analysis. |
Utilize risk-based approaches for resource allocation
Perform risk analysis and implement risk management
Develop systems to monitor and evaluate the impact of risk-based approaches for resource allocation
Timely access to new quality-assured medical products
Strengthen registration efficiency and timeliness
Establish and refine value-added registration processes, resources, and systems
Build value-added technical capacity of assessors
Strengthen inspection capacity and effectiveness
Enhance information sharing and use and reliance on existing inspection resources
Build capacity of multi-disciplinary teams of inspectors
The South African Health Products Regulatory Authority (SAHPRA), formerly the Medicines Control Council, was invited to join PIC/S in July 2007 – a first for an African country. PIC/S support to NRAs focuses on strengthening their inspectorates by harmonizing good manufacturing practices (GMP) standards and processes for inspection of quality systems, promoting networks and information exchange with other NRAs, and supporting training and capacity building of GMP inspectors. South Africa’s process for PIC/S membership began with application in 1997.
A key step in enabling this process was ensuring buy-in and support of all stakeholders, including government and industry. Legislative amendments to the Medicines Act were passed in 2003 to further strengthen licensing arrangements for the manufacturing, import, export, wholesaling, and distribution of medicines. During the application process, the NRA reviewed its existing procedures to identify areas of improvement. The NRA designed and implemented a quality management system that incorporated a quality manual, technical guidelines, and standard operating procedures for all inspection activities, highlighting confidentiality, code of conduct, ethics, and conflict of interest. Improving the capacity of the inspectorate also focused on strengthening administrative, structural, and technical components. Through a series of workshops held between 2004 and 2006, local industry was engaged to adopt the new PIC/S GMP guidelines and ensure their effective implementation, compliance, and enforcement. This process was supported by local technical experts as well as experts from PIC/S member countries to ensure a common interpretation and understanding of the technical principles by both inspectors and industry. Removing barriers to effective communication and encouraging transparency and feedback were key to ensuring the support and compliance of industry stakeholders.
In September 2006, PIC/S inspectors assessed the NRA’s progress and made several observations, which were addressed, resulting in admission the following year as PIC/S′ 31st Participating Authority. SAHPRA continues to strengthen its regulatory capacity by tapping into the pool of PIC/S expertise. PIC/S membership has provided opportunities for networking with counterpart NRAs; promoting quality systems and participating in Joint Visit Programmes, Expert Circles, subcommittees, and working groups.
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Limited evidence-based data to support post-marketing regulatory action
Develop and implement risk-based post-marketing quality surveillance systems
Australia’s NRA, the Therapeutic Goods Administration (TGA), has been 100% cost recovered (autonomous, but self-funded) since the late 1990s. Cost-recovery compels the organization to think strategically about the implementation of its regulatory functions. In 2011, TGA assessed its testing program, identified areas of improvement, and set a roadmap for investing in and establishing a risk-based PMQS program for its programmed testing activities. Risk management standards were consulted and adapted to TGA’s context, principles were identified (e.g., the program would need to be dynamic, iterative, and responsive to change), and a framework and related foundational processes were developed (e.g., risk analysis, risk management, impact evaluation, risk communication).
The program took 3 years to develop, primarily because of the complexity of designing a system that would cater to and enable risk scoring of all product categories (e.g. over-the-counter medicines, complementary medicines, and medical devices). The program has now been active for several years and, importantly, publishes testing data through TGA’s website. Products that undergo a more intensive pre-market assessment (e.g. prescription medicines), tend to score lower and are therefore tested less frequently. However, groups within categories can be scored differently. For example, both vaccines and biological medicines are regulated as prescription medicines in Australia but score more highly than other prescription medicines in general. This is due to the increased complexity of the products and increased complexity of manufacturing; in the case of vaccines, it is also because they are given to an entire cohort of healthy children every year. The risk category of a product can also be elevated (a dynamic program) in response to specific factors, such as poor GMP, failed laboratory testing results, or adverse event reports.
Key to the success of the program was political will and staff commitment, which enabled the development and implementation processes to be followed thoughtfully and have led to less resource waste, increased effectiveness (e.g., shifting the type of products that are tested), and identification of poor-quality products.
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