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Electronic Data Standards

Electronic Data Standards

Electronic data standards give regulators and industry a common language for exchanging information about medicines across the product lifecycle. The Electronic Data Standards Priority Work Area (PWA) of the Regulatory Harmonization Steering Committee (RHSC) supports training and capacity building on key international data standards. Its goal is greater consistency, quality, and interoperability of regulatory information across APEC economies. The PWA will prioritize a set of standards that may include the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards, the Electronic Common Technical Document (eCTD), Clinical Data Interchange Standards Consortium (CDISC) standards, relevant guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and clinical and nonclinical terminologies.

The PWA aims to:

  • increase awareness and understanding of international data standards, and encourage their adoption to improve regulatory processes and public health outcomes;
  • promote harmonization of data standards and interoperability of regulatory information systems;
  • build the capacity of regulatory professionals through training and continuous learning; and
  • support the implementation of data standards in regulatory processes, and their continuous improvement as technology evolves.

The work is organized in three phases: awareness and initial adoption; implementation and harmonization; and evaluation and continuous improvement. The PWA is designed to bring together regulatory authorities, industry representatives, and technical experts.

CHAMPION

  • U.S. Food and Drug Administration (FDA), United States

The PWA Champion’s contacts can be found here.

CENTERS OF EXCELLENCE

The RHSC has not yet designated a Center of Excellence for this PWA.

ROADMAP

The Electronic Data Standards PWA roadmap can be found here.