Pharmaceutical Regulatory Glossary
Clear definitions of the regulatory agencies, compliance standards, and data identifiers that shape pharmaceutical engineering — and how Biocore relates to each.
Agencies & Frameworks
- FDA
The US Food and Drug Administration, the federal agency that approves and regulates drugs, biologics, and medical devices in the United States.
FDA decisions and labeling drive product launches, safety updates, and compliance obligations for any company operating in the US market.
Biocore: Biocore ingests FDA labeling via DailyMed and normalizes it alongside seven other authorities so US data sits in the same schema as the rest.
- EMA
The European Medicines Agency, responsible for the scientific evaluation and supervision of medicines across the European Union.
EMA centrally authorizes many medicines for the entire EU, making its assessments a single high-value source for European market data.
Biocore: Biocore captures EMA EPAR data and maps it into the same normalized fields used for FDA and PMDA, simplifying multi-region analysis.
- PMDA
The Pharmaceuticals and Medical Devices Agency of Japan, which reviews marketing applications and monitors post-market drug safety.
Japan is one of the largest pharmaceutical markets, and PMDA data is essential for global label and safety tracking.
Biocore: Biocore includes PMDA among its eight covered jurisdictions, normalizing Japanese regulatory records for cross-market comparison.
- MHRA
The UK Medicines and Healthcare products Regulatory Agency, which regulates medicines and medical devices in the United Kingdom.
Post-Brexit, the UK maintains an independent regulatory pathway, so MHRA data must be tracked separately from the EU.
Biocore: Biocore monitors MHRA alongside EMA, surfacing UK-specific regulatory changes that diverge from European decisions.
- TGA
Australia's Therapeutic Goods Administration, which regulates the supply, import, and manufacture of therapeutic goods.
TGA approvals and the ARTG register govern market access for medicines in Australia.
Biocore: Biocore covers TGA records in its normalized corpus, extending consistent regulatory data to the Australian market.
- Health Canada
The Canadian federal department responsible for approving and regulating drugs and health products in Canada.
Health Canada operates its own Drug Product Database, requiring dedicated monitoring for Canadian market coverage.
Biocore: Biocore normalizes Health Canada drug product data alongside seven other authorities for unified Canadian coverage.
- ANSM
France's Agence nationale de sécurité du médicament et des produits de santé, the national medicines safety agency.
ANSM publishes French-language product summaries (RCP) and national safety communications relevant to the French market.
Biocore: Biocore captures ANSM records and normalizes them, making French regulatory data accessible without language or format barriers.
- Swissmedic
The Swiss Agency for Therapeutic Products, which authorizes and supervises medicines in Switzerland.
Switzerland sits outside the EU regulatory framework, so Swissmedic data must be tracked independently.
Biocore: Biocore includes Swissmedic in its eight-jurisdiction coverage, normalizing Swiss authorizations for cross-market work.
- DailyMed
The US National Library of Medicine service that publishes the FDA's official current drug labeling in SPL format.
DailyMed is the authoritative, machine-readable source for US prescribing information and is queried directly by many developers.
Biocore: Biocore ingests DailyMed SPL feeds and normalizes them into structured fields, removing the need to parse raw SPL XML.
- openFDA
A public FDA API offering programmatic access to raw FDA datasets such as drug labels, adverse events, and recalls.
openFDA is a common starting point for developers but covers only FDA data with no normalization or service-level guarantee.
Biocore: Biocore goes beyond openFDA with eight-jurisdiction coverage, normalized fields, webhooks, and an SLA for production use.
Compliance Standards
- 21 CFR Part 11
A US FDA regulation governing electronic records and electronic signatures, including audit trails, access controls, and record integrity.
Part 11 compliance is mandatory for regulated electronic systems used in FDA-governed pharmaceutical work.
Biocore: Biocore provides audit trails, access controls, electronic signature support, and a Part 11 feature matrix for regulated deployments.
- GxP
A collective term for Good Practice quality guidelines including GMP, GCP, GLP, and GVP across manufacturing, clinical, laboratory, and pharmacovigilance activities.
GxP frameworks define how regulated data and systems must be controlled and validated in life sciences.
Biocore: Biocore supplies IQ/OQ/PQ validation documentation and audit-ready data to support customers operating in GxP environments.
- IQ/OQ/PQ
Installation, Operational, and Performance Qualification — the three-stage validation process confirming a system is installed, operates, and performs as intended.
These qualifications are core evidence that a computerized system is fit for use in a regulated environment.
Biocore: Biocore provides IQ, OQ, and PQ protocol templates and test scripts to accelerate customer validation efforts.
- CSV
Computer System Validation — the documented process of confirming a computerized system consistently produces results meeting predetermined specifications.
CSV is required for any system handling regulated data, ensuring reliability and audit-readiness; it is distinct from the comma-separated-values file format.
Biocore: Biocore supplies system documentation and validation materials that feed directly into a customer's CSV effort.
- SOC 2 Type II
An independent audit report attesting that an organization's security and availability controls operated effectively over a defined period.
SOC 2 Type II is a standard requirement in vendor security assessments and procurement reviews.
Biocore: Biocore maintains SOC 2 Type II-aligned controls and provides the report to enterprise customers under NDA.
- GDPR
The EU General Data Protection Regulation, which governs processing of personal data of individuals in the European Union.
For pharma data vendors, GDPR shapes how clinical and personal data are stored, transferred, and processed in the EU.
Biocore: Biocore offers Data Processing Agreements and an EU data residency option for customers with GDPR obligations.
- ALCOA+
Data integrity principles requiring records to be Attributable, Legible, Contemporaneous, Original, and Accurate, plus Complete, Consistent, Enduring, and Available.
ALCOA+ is the benchmark regulators use to judge whether data can be trusted in inspections and audits.
Biocore: Biocore's provenance tracking, timestamps, and tamper-evident logging are built to uphold ALCOA+ expectations.
- IDMP
ISO Identification of Medicinal Products, a set of standards for uniquely identifying and describing medicinal products.
IDMP is increasingly required by the EMA for consistent, machine-readable product identification across the EU.
Biocore: Biocore structures its product data to align with IDMP-style identification, easing future EMA reporting workflows.
- eCTD
The electronic Common Technical Document, the standard electronic format for submitting regulatory information to agencies like the FDA and EMA.
eCTD is the required submission format for most regulatory filings, structuring dossiers into defined modules.
Biocore: Biocore's structured regulatory data supports teams assembling and cross-referencing content destined for eCTD submissions.
Data Formats & Identifiers
- NDC
The National Drug Code, a unique three-segment numeric identifier the FDA assigns to human drugs in the United States.
NDCs are the primary key for identifying US drug products in pricing, dispensing, and regulatory systems.
Biocore: Biocore exposes NDC identifiers on US records so developers can join Biocore data to existing drug databases.
- EPAR
The European Public Assessment Report, the EMA's published explanation of the basis for approving a centrally authorized medicine.
EPARs document the EMA's efficacy and safety assessment and are a primary source for EU product intelligence.
Biocore: Biocore parses EPAR content into normalized fields, making EU assessment data queryable alongside other jurisdictions.
- SPL
Structured Product Labeling, an HL7 XML standard the FDA uses to exchange drug labeling in a machine-readable format.
SPL is the underlying format of US drug labels, but raw SPL XML is verbose and difficult to consume directly.
Biocore: Biocore normalizes SPL into clean structured fields, sparing developers from parsing complex XML themselves.
- RxNorm / RxCUI
RxNorm is a normalized naming system for clinical drugs, and RxCUI is the unique concept identifier it assigns to each drug concept.
RxNorm/RxCUI identifiers let systems map between brand names, generics, and formulations consistently.
Biocore: Biocore aligns its drug records with RxNorm concepts so teams can normalize and deduplicate across data sources.
- UNII
The Unique Ingredient Identifier, an FDA code that uniquely identifies substances such as active pharmaceutical ingredients.
UNIIs allow precise identification of ingredients independent of naming variation across products and markets.
Biocore: Biocore attaches UNII identifiers to ingredient data, enabling reliable substance-level matching across jurisdictions.
- Drug label / prescribing information
The official document describing a drug's approved uses, dosing, warnings, contraindications, and safety information.
The label is the authoritative reference for how a drug may be used, making it central to clinical and compliance work.
Biocore: Biocore normalizes labels and prescribing information into segment-level fields across all eight jurisdictions.
- Pharmacovigilance / adverse event
Pharmacovigilance is the science of monitoring drug safety; an adverse event is an undesirable experience associated with a drug's use.
Adverse event data underpins ongoing safety monitoring and regulatory reporting obligations after a drug reaches market.
Biocore: Biocore provides structured adverse reaction and safety data, supporting pharmacovigilance monitoring workflows.
- Regulatory data normalization
The process of transforming regulatory records from many sources and formats into a single consistent structure and schema.
Without normalization, comparing data across agencies means reconciling incompatible formats, languages, and field definitions.
Biocore: Normalization is Biocore's core function: it maps 17+ sources into one schema so every jurisdiction is queried identically.
Regulatory Terms FAQ
The FDA is the US regulator for drugs and devices, and its labeling decisions shape compliance across the industry. Biocore tracks FDA labeling through DailyMed and delivers it as structured JSON, so teams consume current US prescribing information without scraping agency pages themselves.
The EMA evaluates and supervises medicines for the European Union and publishes EPARs for centrally authorized products. Biocore normalizes EMA data into the same schema as FDA and PMDA, so engineering teams query EU and US regulatory information through one consistent API rather than reconciling separate formats.
The PMDA reviews drug applications and monitors safety in Japan, one of the world's largest pharmaceutical markets. Biocore covers PMDA as one of eight jurisdictions and normalizes its records into a shared schema, letting teams compare Japanese regulatory data against other markets without custom ingestion.
The MHRA regulates medicines and devices in the United Kingdom on a pathway now independent from the EU. Biocore tracks MHRA separately from EMA and normalizes both, so teams catch UK-specific divergences in labeling and approvals without manually comparing two agencies' published documents.
The TGA regulates therapeutic goods in Australia and maintains the ARTG register of approved products. Biocore includes TGA in its eight-jurisdiction corpus and normalizes its records, giving teams Australian regulatory data in the same structured format they use for FDA, EMA, and other authorities.
Health Canada approves and regulates drugs in Canada and maintains the Drug Product Database. Biocore normalizes Health Canada data into its shared schema as one of eight covered jurisdictions, so Canadian regulatory information is queryable through the same API as every other market Biocore supports.
ANSM is France's national medicines safety agency, publishing product summaries and safety communications in French. Biocore captures and normalizes ANSM records into its shared schema, so teams access French regulatory data programmatically without managing separate parsing or language-specific source formats themselves.
Swissmedic authorizes and supervises medicines in Switzerland, which operates outside the EU regulatory framework. Biocore tracks Swissmedic as one of its eight jurisdictions and normalizes its data, letting teams include Swiss authorizations in multi-market analysis through a single consistent API.
DailyMed publishes the FDA's official drug labeling in machine-readable SPL format and is the authoritative source for US prescribing information. Biocore ingests DailyMed and normalizes its SPL XML into structured JSON fields, so developers consume clean US label data without writing their own SPL parsers.
openFDA provides raw, FDA-only datasets through a public API with no cross-jurisdiction coverage, normalization, or SLA. Biocore complements that gap by delivering eight jurisdictions in one normalized schema, with webhooks and a service-level agreement suited to production systems rather than exploratory queries.
21 CFR Part 11 sets FDA requirements for trustworthy electronic records and signatures in regulated environments. Biocore supports it with audit trails, access controls, electronic signature capability, and a feature matrix, while customers remain responsible for validating and operating the system within their own compliance processes.
GxP covers Good Practice guidelines spanning manufacturing (GMP), clinical (GCP), laboratory (GLP), and pharmacovigilance (GVP) activities. Biocore supports GxP deployments by providing validation documentation packages and audit-ready, traceable data, helping regulated teams meet the control and validation expectations these frameworks impose on computerized systems.
IQ/OQ/PQ is the qualification sequence proving a system is installed correctly, operates to specification, and performs reliably in use. Biocore provides IQ, OQ, and PQ protocols and test scripts so customers can validate the platform efficiently while retaining responsibility for executing validation in their own environment.
Computer System Validation is the documented assurance that a regulated system reliably meets its specifications — not to be confused with the spreadsheet file format. Biocore supports CSV efforts with architecture documentation, validation protocols, and change-control records that customers incorporate into their own validation lifecycle.
SOC 2 Type II is an independent attestation that security and availability controls operated effectively over time, commonly required during procurement. Biocore maintains SOC 2 Type II-aligned controls and provides the audit report to enterprise customers under NDA, typically within five to seven business days of request.
For pharmaceutical data vendors, GDPR governs how personal and clinical data tied to EU individuals are processed, stored, and transferred. Biocore addresses this with Data Processing Agreements, an EU data residency option, and privacy-by-design controls, focusing on the obligations that apply specifically to regulated pharma data handling.
ALCOA+ defines the data integrity attributes regulators expect — attributable, legible, contemporaneous, original, accurate, and more. Biocore upholds these through full provenance tracking, precise timestamps, and tamper-evident audit logs, so the regulatory data it delivers can withstand inspection scrutiny in GxP-regulated workflows.
IDMP is the ISO standard set for uniquely identifying medicinal products, increasingly mandated by the EMA for machine-readable product data. Biocore structures its regulatory corpus around consistent product identification compatible with IDMP-style requirements, reducing the reconciliation work teams face when preparing EMA-aligned submissions.
The eCTD is the standardized electronic format for regulatory submissions to agencies such as the FDA and EMA, organizing dossiers into defined modules. Biocore's normalized regulatory data helps teams gather and cross-reference accurate source content as they assemble submission packages bound for eCTD filing.
The NDC is the FDA's unique identifier for US drug products, encoding labeler, product, and package size. Biocore surfaces NDCs on its US records, so developers can reliably join Biocore's normalized regulatory data to internal pricing, dispensing, or inventory systems keyed on the National Drug Code.
An EPAR is the EMA's published assessment explaining why a centrally authorized medicine was approved in the EU, covering efficacy and safety. Biocore parses EPAR content into normalized fields, letting teams query European assessment data programmatically alongside FDA, PMDA, and other jurisdictions in one schema.
SPL is the HL7 XML standard the FDA uses for machine-readable drug labeling, and DailyMed publishes labels in this format. Biocore normalizes SPL into clean, structured JSON fields, so developers retrieve usable label content directly instead of building and maintaining their own SPL XML parsers.
RxNorm provides normalized clinical drug names and assigns each concept an RxCUI identifier, enabling consistent mapping across brands, generics, and formulations. Biocore aligns its drug records with RxNorm concepts, helping developers deduplicate and reconcile drug data across Biocore and their existing clinical or analytics systems.
The UNII is the FDA's unique code for identifying substances like active pharmaceutical ingredients, independent of naming differences. Biocore attaches UNIIs to ingredient data so teams can match substances precisely across products and jurisdictions, supporting accurate ingredient-level analysis that brand or generic names alone cannot guarantee.
A drug label, or prescribing information, is the authoritative document covering approved uses, dosing, warnings, and safety for a medicine. Biocore normalizes labels into segment-level fields across eight jurisdictions, so teams can compare sections like boxed warnings or contraindications programmatically rather than reading full documents manually.
Pharmacovigilance monitors drug safety after approval, and adverse events are the undesirable experiences it tracks. Biocore delivers structured adverse reaction and safety data across jurisdictions, giving pharmacovigilance and compliance teams machine-readable inputs for ongoing safety surveillance instead of manually compiling signals from disparate agency sources.
Regulatory data normalization converts records from many agencies and formats into one consistent schema. It matters because raw sources differ in structure, language, and field meaning. Normalization is Biocore's core function — it maps 17+ sources into a single schema so every jurisdiction is queried the same way.
Build on normalized regulatory data
Biocore turns every term on this page into structured, queryable data across eight jurisdictions.