Structured Product Labeling (SPL) and Product Information Management (PIM); What are they?

About SPL

Health Level Seven (HL7), an ANSI accredited standards development organization, has developed a new technology for exchanging information between computer systems. Known as Clinical Data Architecture (CDA), it allows information to be exchanged in extensible markup language (XML) and is the standard being investigated for the Electronic Health Record (EHR).

The Food and Drug Administration (FDA), working with other interested parties in HL7, has adapted CDA for labeling in a proposed HL7 standard called Structured Product Labeling (SPL). When compared with PDF, SPL provides the following advantages:

• SPL allows the exchange of information between computer systems (to support patient safety initiatives, for example) in a way that cannot be accomplished with PDF.
• The exchange of labeling changes with SPL can be easier and more efficient for both the FDA and manufacturers when compared with PDF. For example, with SPL, only those sections or data elements of the labeling, which are changed, would need to be submitted - rather than the complete labeling.
• SPL lets you compare text and specific data elements.
• SPL can also be used to exchange information needed for other submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency.

Further reading from the FDA

• Structured Product Labeling resources
  http://www.fda.gov/oc/datacouncil/spl.html
• Guidance for Industry (Word document)
  http://www.fda.gov/cder/guidance/6028dft.doc

About PIM

Product Information Management (PIM) is a joint project of the European Agency for the Evaluation of Medicinal Products (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Its aim is to streamline secure electronic submission of product information to the relevant authorities in the European Union.

For more information, visit: www.emea.eu.int or www.efpia.org.