Live board

• Legality: Regulatory systems and the decisions derived from them must have a solid legal basis.

• Independence: Institutions responsible for regulating pharmaceutical products must be independent.

• Proportionality: Regulation and regulatory decisions must be proportionate to the risk and the regulator's capacity to implement and enforce them.

• Clarity: Regulatory requirements must be accessible to and understood by users.

• Transparency: Regulatory systems must be transparent, requirements and decisions must be made public, and input on regulatory proposals must be solicited.

• Consistency: Regulatory oversight of pharmaceutical products should be consistent with existing government policies and legislation and should be applied in a uniform and predictable manner.

• Impartiality: All regulated parties should be treated equitably, fairly, and impartially.

• Flexibility: Regulatory oversight should not be prescriptive but flexible in order to respond to a changing environment and unforeseen circumstances. Timely responsiveness to specific needs, particularly public health emergencies, should be built into the regulatory system.

• Efficiency: Regulatory systems should achieve their objectives within the required time frame and at reasonable effort and cost. International collaboration promotes efficiency by ensuring the best use of resources.

These principles are essential to ensure that regulatory authorities in Latin America can fulfill their mandate to protect public health while facilitating access to safe and effective medicines.

• Political and whole-of-government support: Sustained support from the highest political and governmental levels, including policymakers, is essential for the successful implementation of the concept and principles of good regulatory practices.

These good practices should be an integral part of all government policies on regulatory systems and have strong political support.

Communication, collaboration, and coordination: Adequate and effective communication plays a key role in the exchange of information within and outside the institutions that make up the regulatory system. When regulatory authorities communicate regularly, both internally and externally, they remain more transparent and accountable. Communicating accurate information prevents potential misunderstandings and the dissemination of misleading information to patients and the public. Communication is a powerful tool for collaboration and coordination with relevant national and international stakeholders, which in turn leads to efficient use of resources and better regulatory outcomes.

Given their responsibilities, regulatory authorities must have adequate staff, infrastructure, and technical tools to perform their tasks. Coordination can be facilitated by communication technologies and the efficient and rapid exchange of information, resulting in fewer gaps and less duplication of effort.

• Adequate and sustainable financial resources: Investment in a regulatory system is essential for the proper functioning of a health care system. Having sufficient financial resources to effectively fulfill its regulatory mandate and continuously improve the performance of regulatory activities is essential for the independence, impartiality, consistency, and efficiency of a regulatory system. The financial resources of all institutions in the regulatory system must be sustainable, apart from contributions from donors or philanthropic entities.

• Ethics and institutional values: Regulatory staff must comply with the institution's ethical principles and values and demonstrate professionalism. All regulatory staff must be aware of and receive training on the ethical principles and values of the regulatory authority (e.g., a code of conduct). A system must be established, within or outside the regulatory system, to manage deviations from ethics and institutional values.

• Robust quality management system: A quality management system, including the application of quality risk management principles, makes regulatory decisions more credible and regulatory operations more stable and consistent. A quality management system contributes to systematic planning, control, and improvement of quality across all regulatory processes and ensures a comprehensive approach.

Science- and data-based decision-making process: Regulatory decisions and decision-making should be based on scientific evidence and accurate data, not intuition or arbitrariness. Science-based decisions lead to consistent and predictable regulatory outcomes. Adherence to international standards and guidelines is a key enabler of science-based regulatory decision-making.

The enabling factors listed above are not effective when present individually. Rather, these factors work in harmony in the application of good regulatory practices. For example, sufficient and sustainable financial resources contribute to the recruitment, development, and retention of competent human resources. Likewise, financial resources must be managed in accordance with good governance practices.

Effective organization and good governance: The structure and chain of authority among all institutions in the regulatory system and within each of them must be well defined. The integrity of the overall regulatory system is fundamental to the efficient performance of each of its constituent institutions.

If more than one institution is involved in the regulatory system, legislation or institutional regulation should provide for clear coordination and no overlap of regulatory activities. Leadership is essential to establishing and realizing the organization's vision, mission, policies, and strategies, which in turn contribute significantly to its efficiency.

• Competent human resources: A range of technical and scientific knowledge and skills among regulatory staff contribute to the development, implementation, and maintenance of an effective regulatory system for medical products. Policies and measures for personal and professional development (e.g., training programs, competitive compensation schemes) are essential for regulatory authorities to attract competent staff and retain them in service.