While not specific to rheumatology, including patients in the regulatory process paves the way for advances in therapeutic outcomes.
- 2000: The European Medicines Agency (EMA) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU www.ema.europa.eu invites patients as committee members and the Food and Drug Administration (FDA)Food and Drug Administration’s (FDA) evaluation of new medicines (United States). During clinical trials, researchers study whether new medicines are safe and effective for patients and whether the medicine’s benefits outweigh the risks.
www.fda.gov expands the Patient Representative role to serve as consultants to scientific and regulatory reviewers. - 2003: EMA expands to patient inclusion in working groups.
- 2005: EMA establishes their first collaboration framework for regulatory practices between EMA and patients and consumers and their organizations, which was revised in 2014.
- 2006: The EMA establishes the Patients’ and Consumers’ Working Party (PCWP) EMA is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The Patients’ and Consumers’ Working Party (PCWP) provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers. www.ema.europa.eu, which provides a platform for the exchange of information and discussion of issues of common interest between EMA and patients and consumers. The PCWP provides recommendations to EMA and its human scientific committees on all matters of interest in relation to medicines.
CoPI: Working groups, regulatory reviewers, consumer reviewers
Context: Regulatory process