Vaccines, Blood & Biologics
International Electronic Standards
Individual Case Safety Report (ICSR)
CBER has provided leadership and technical support for the development of an internationally- accepted standard and Step 4 ICH Implementation Guide for electronic exchange of adverse event and medication error reporting between ICH global regulators (US, EU, Japan and Observers), pharmaceutical/biopharmaceutical manufacturers and the World Health Organization. Finalized in the fall of 2012, this work culminates eight years of international collaboration with several standards development organizations, regulated industry, global regulators, healthcare providers and vendors to establish standards that will improve and transform global pharmacovigilance activity. The Individual Case Safety Report (ICSR) is a global, multi-part ISO standard that supports all FDA regulated products, and various releases of this specification have been adopted by three FDA Centers - two of which have done under the International Conference on Harmonisation (ICH E2B), and the Veterinary Conference on Harmonisation (VICH GL42), which FDA's Center for Veterinary Medicine implemented in 2010. Reaching Step 4 status in ICH, E2B is a considered a major milestone because it aligns FDA’s human drug and biologics adverse event (AE) reporting format with standards used in the healthcare sector.
Additional benefits include addressing gaps with the current ICH E2B reporting specification which does not adequately support FDA-regulated vaccines, tissues, blood components or combination products. The agency can leverage the ISO ICSR specification to create additional regional reporting guides without compromising the overall reporting format or processing requirements for non-ICH/VICH reporting (e.g., dietary supplements, food, tobacco, medical devices), which supports IT infrastructure reuse for both the agency and global manufacturers that produce a variety of medical/health products that are subject to FDA reporting. CBER completed Phase I vaccine pilot testing in 2012, which included the creation of a new electronic submissions template (eSubmitter - which is based upon the updated ICH Step 4 guideline) to create and send reports through FDA's Electronic Submissions Gateway. Future CBER activities include collaboration with the European Medicines Agency (EMA) to expand use of CBER’s template for international pilot testing for drugs, biologics and vaccines.
Identification of Medicinal Products (IDMP)
Validation and verification of product information across regulatory submissions, especially in adverse event (AE) reports, product labeling, manufacturing facility registration and lot distribution reports has been a major challenge for the Agency and internationally, which limits its ability to reconcile and link information across a product's lifecycle (pre-market to post-market). A CBER staff member served as the FDA Topic Leader for the ICH M5 Expert Working Group: Data Elements and Standards for Drug Dictionaries, and delegate of the US Technical Advisory Group within the International Organization for Standardization (ISO), providing leadership and support for the development of a suite of ISO standards for the Identification of Medicinal Products (IDMP), which provide an internationally-accepted framework for consistent documentation, coding and exchange of product information between global regulators, manufacturers, suppliers and distributors. The tremendous benefit to healthcare providers and to the Agency is the ability to harness the power of information technology by using these standards to support automated validation of content, eliminate manual data entry and coding errors, reduce redundant submission of the same information, and facilitate the creation and use of global drug dictionaries and product dossiers. The suite of ISO IDMP standards provides a mechanism for globally unique identification of medicinal products on an international level by developing a method and process for generating global product identifiers that can be used for international product reconciliation and linking across the entire product supply-chain. The suite of IDMP standards include: substances/specified substances, dosage forms, routes of administration, units of measurement, pharmaceutical product identification, and medicinal product identification.
These international standards will provide a globally-accepted coding terminology and exchange method which can be used to support a variety of product-related activities and events: manufacturing, distribution and use throughout the global healthcare marketplace, validate and monitor correct product usage (based upon a product's labeling information) and AE surveillance. These standards will be used to assist in the creation of an international drug dictionary, which can be used to populate and validate product information in electronic health records, pharmacy information and prescribing systems, product registries, pharmacovigilance systems and adverse event reports. The IDMP standards are consistent with other HHS initiatives for Health Information Technology (HIT) adoption under Meaningful Use (MU) for electronic prescribing.