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. 2018 Aug 17;5:230. doi: 10.3389/fmed.2018.00230
Relevance Patients have knowledge, perspectives and experiences that are unique and contribute significantly to essential aspects of regulatory activities.
Fairness Patients have the same rights to contribute to the regulatory activities as other stakeholders and have access to knowledge and experiences that enable effective engagement.
Equity Patient involvement in regulatory activities contributes to equity by seeking to understand the diverse needs of patients with particular health issues, balanced against the strict requirements of regulatory legislation and guidelines.
Legitimacy Patient involvement facilitates those affected by regulatory decisions to participate in regulatory activities; contributing to the transparency, accountability and credibility of the decision-making process.
Capacity building Patient involvement processes address barriers to involving patients in regulatory activities and build capacity for patients and regulatory authorities to work together.