The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Lays Out First Steps in Implementing ISO Standards for Drug Identifiers

Dec. 9, 2016

The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018.

The new data standards, called SPOR for substance, product, organizations and referentials, are designed to provide a common set of definitions to be used in pharmacovigilance, submission, clinical trials and GMP inspections.

The EMA released details on two of the four SPOR data sets: organizations and referentials. The organizations data set focuses on name and address information for marketing authorization holders, sponsors, regulatory authorities and manufacturers. The referentials data set focuses on product attributes, such as dosage forms, units of measurement and routes of administration.

The other two data sets, substance and product, will be issued later. Substance data covers the ingredients and materials that constitute a particular drug and product data details  marketing authorization, packaging and medicinal information.

Full implementation of the two data sets is expected in the second half of 2017, the EMA said.

Previously, the EMA submitted referential and organization data through EudraVigilance Medicinal Product Dictionary. The new approach is intended to provide sponsors with access to data stewards, who will specialize in managing the data sets, and a centralized system that generates and maintains referential and organization IDs for regulatory submissions across the EU.

This updated edition of Implementing an 11-Step Plan for Device Software Validation and Verification contains a new chapter outlining the software validation requirements in ISO 13485:2016. You'll also find out what the FDA accepts as an appropriate documentation model … the agency’s expectation for your testing software, ERP software and more … and, when and how to use design qualification, installation qualification, operational qualification and performance qualification.