SPL regulations

When implemented, the European Medicines Agency's (EMA) Product Information Management (PIM) system is intended to provide greater consistency and quality in information provided with marketing authorisation applications.

The system should prevent the replication of data in submissions, which will shift from a word document format to an XML.

The EMA began its pilot phase of the project in the second quarter of 2009, with the intention of having the project up and running within the following two years.

Milestones laid out in the statement of intent, issued in September 2009, suggested that by the end of next year, all the centrally authorised product information could have been transferred to the PIM format.

From this point forward the system will be "strongly recommended for all new marketing authorisation applications and post-authorisation activities." Implementing the PIM system

A pilot scheme has already taken place involving the PIM with a small number of companies and products, but before the format is adopted on a larger scale, pharmaceutical firms must undertake some series preparation.

EMA said the pilot had "not been free of issues for the applicants", which included GlaxoSmithKline, Genzyme and Merck Serono, according to PharmaTech.com.

Throughout the pilot process a number of changes were made to the data exchange standard, to ensure that all products fit with the system.

Both the PIM review system, which is used by various National Competent Authorities, and the Light Authoring Tool, which is used by small and medium enterprises for "basic capability to build XML-based product information", were shown to present issues with both "performance and usability."

In conclusion, the EMA detailed that there were an "extensive set of criteria" before the PIM could be implemented on a larger scale.

Five companies handling participated in the PIM trial, handling seven different products .

The project is very similar in nature to the Structured Product Labelling (SPL), which was introduced by the Food and Drugs Agency in the United States a number of years ago. PIM and SPL

Pharmaceutical companies are expected to receive a number of benefits from the PIM system, which are similar to those received from users of the SPL.

Kris Spahr, of the SPL Working Group, speaking to DCL news, highlighted: "XML helps with eliminating redundant data collection used for other submissions.

"It also increases efficiency in internal label management, allowing the potential for more reusable product content across the enterprise. Plus it defines a consistent, predictable means of exchanging labelling content."

The SPL also allowed for keyword search, which was not possible with PDF documents.

A senior PIM manager at the EMA told Pharmstech.com that the SPL regulations across the Atlantic were encouraging more companies than those involved in the pilot to access PIM, as they are "focusing on ways to manage information worldwide." Benefits and challenges of PIM

Once the PIM system is fully implemented, EMA believes that it will hold a number of benefits for pharmaceutical companies.

There will no longer be the need to provide either paper or work documents as part of a submission, and EMA believes the system will allow applicants to focus on the content of the submission rather than the formatting.

Comments in response to the submission will also be simplified and the greater consistency should allow for benefits across the industry.

Yet these benefits do not come without their challenges. Companies will have to make the transition to an XML format, which could present some technical challenges.

The pilot project found that business processes must be adapted to ensure optimum use of the PIM system.

"In the pilot, the PIM system was used primarily with the current business process. To maximise benefits, the processes need to be refined based on experience that has been gained during the pilot," EMA explained.

Writing for PharmaTech.com, Bruce Sharpe also highlighted that a one-size-fits all approach to the adoption of PIM is not a solution.

"Implementation of PIM systems must be carefully managed and meet the individual needs of companies," he explained.

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