By now, regulatory teams and IT departments within pharma companies have grown used to the precise demands of the FDA and equivalent overseas authorities when it comes to submitting dossiers in support of new drug license applications, amendments and updates, and product labeling. Rates for compliance with the current electronic common technical document (eCTD) standard are impressively high in the United States, which leads the way globally in electronic submissions. The eCTD standard dictates how documentation must be published and structured, to make it as easy as possible for the regulators to review. Unsurprisingly, since the standard originated here, the U.S. market was the first to make it mandatory for pharma companies to use the specification for electronic submissions. Other territories are following suit, but adoption rates across Europe, in particular, vary considerably.
Preparing For What Lies Ahead
The new refined version of the standard offers even greater efficiencies to the pharma industry. eCTD in its original form has been around for a long time now. Version 3.0 was issued in October 2002. Since then there have been only minor tweaks, until the arrival of eCTD version 4, that is — the new regulated product submission (RPS) standard, which aims to take eCTD to the next level.
Pharma organizations should not be alarmed by the emergence of what may at first seem to be further hoops to jump through. Particularly where companies are still in the early stages of eCTD adoption, advance awareness of the RPS specification offers an opportunity to refine processes as they go, knowing that the benefits are likely to outweigh any additional work that has to be done.
The emphasis of the new RPS standard is to build on the original goals of eCTD, adding more flexibility and robust capabilities, in recognition that the original eCTD standard has a number of limitations. The eCTD format is limited to human pharmaceuticals, for example. This has created inefficiencies for regulatory authorities such as the FDA. Currently, there are different electronic standards for each division, and not every division even has an electronic standard. The situation is costly for the FDA, which has to allocate staff to manage and maintain each of those systems. A single system covering all of the divisions — comprising food additives, medical devices, human therapeutics, and veterinary medicines — would simplify things considerably.
There are technical limitations, too, involving tagging and the way additional information is supported by eCTD, with differences emerging between different regions in the way that content gets handled, despite the standard having been designed to be international in scope. Similar restrictions apply to the way documents are managed across the lifecycle of a product, as amendments get made and old information is superseded.
The RPS standard has been in development since June 2007. The refined version, RPS Release 2, was released in January 2010. This has undergone extensive testing by all major user groups — sponsors, agencies, and software vendors — to ensure it meets everyone’s needs.
One change expected with the next release is simplification of the way information changes get made at the metadata level. For example, when an ingredient manufacturer changes its name, the sponsor must revise a vast number of documents, and there are metadata associated with each of those documents. In the current eCTD, there is no way to change the metadata associated with documents — you would have to mark each one as deleted, then add a new section to the submission with new metadata. In RPS, the document can just be marked as revised with the new metadata.
Something that emerged from testing of Release 2 is the need for a common interpretation of the way the RPS model has to work, in order to ensure all systems implement the model the same way, and to avoid scenarios where one agency’s review system might accept something that may be rejected by another. The current goal is to approve Release 2 as an ANSI standard late in 2012, with ISO approval sought immediately following.
For More Information please click here: Introducing RPS – Taking eCTD To The Next Level - By Joel Finkle
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