Navigating TMF data retention regulations
Understanding the different global data archiving and preservation requirements
Understanding and complying with eTMF archiving regulations
Life sciences regulations are constantly evolving in regard to the long-term management and preservation of clinical trial data. It is therefore vital to stay on top of this new legislation and ensure that you have a strategy in place to adhere to regulatory guidance. In this section, we’ve collated some examples of key areas of regulations to demonstrate the best approach in ensuring that your data is always compliant. These regulations are relatively new, with some from the EU as recent as this year (2022). Although they are not retrospective in their recommendations, any new drugs under development will fall within these guidelines.
...of quality assurance, compliance, legal and regulatory professionals would currently describe their ability to access data and records from a TMF archive as ‘extremely or very inadequate’.
Keeping up with changing global regulations
When it comes to storing the eTMF, every pharmaceutical company, regardless of locality, has a regulatory requirement to keep clinical trial data for the long term. Throughout this retention period, it typically needs to be available, accessible, discoverable and complete. However, geographically, there is a broad range of guidelines that have been supplied across the various governing bodies which can make it difficult when trying to understand the different local regulations. For example, European regulations from the EMA stipulate that storage of the eTMF is required for a minimum of 25 years (EU Regulation 536/2014) whilst FDA guidance doesn’t provide a specific time frame. Recently, there has been a significant trend towards changing requirements for the long-term management of trial data and therefore, it is not unreasonable to expect organisations such as the FDA to follow suit.
Global Impact
It is also worth noting that should a pharmaceutical company want to market a drug outside of their local market, they will need to comply to that region’s regulations. To illustrate, a US pharmaceutical company is likely to market their drug in the European market, therefore, to get marketing approval in Europe they will need to have a long-term retention plan of the eTMF for over 25 years. As you can see, although the regulations can vary from region to region it can be majorly beneficial for a pharmaceutical company, as a form of best practice, to comply with stricter regulations, that way their data is preserved in a way that can serve all markets.
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