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PSUR

Periodic Safety Update Report (PSUR)

The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits.

1 September 2015, companies should use the xml delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client websites

The PSUR XML delivery file for EMA submission is introduced to harmonise the submission mechanism for all PSURs submitted to EMA and it will apply to all types of PSUR and PSUR supplementary information submissions.

PSUR Substances in the “Active Pharmaceutical Ingredients Dictionary”

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SPL

The FDA requires a “Stuctured Product Labeling” (SPL) for the registration of medicinal products.

UNII Substances
Unique Ingredient Identifier – a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. The substances are to be coded by a UNII code.

Country Codes
SPL represents countries with ISO 3166-1 Alpha-3 country codes

SPL – Drug Route of Administration Terminology
Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.
SPL Pharmaceutical Dosage Form Terminology
Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the Structured Product Labeling documents.

SPL Package Type Terminology
Terminology used for representation of the information on pharmaceutical product package type in the framework of the Structured Product Labeling documents.

SPL Unit of Presentation Terminology
Terminology that encompasses dosage form, package type, and unit of measurement (aka potency) terms used in supporting regulatory submissions in electronic format such as drug establishment registration and drug listing.

SPL Unit of Measure Terminology
Terminology that represents units of measure in supporting regulatory submissions in electronic format such as drug establishment registration and drug listing.

Download SPL Controlled Vocabularies from IDMP1:

SPL´s data are actualised by the FDA regularly. Please license our service download SPL Controlled Vocabularies to get noticed the moment the terms and the download files are actualised and to download the actual files.

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XEVMPD

XEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA) which defines controlled vocabulary to be used for the marketing authorisation of medicinal products.

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA).