The Regulatory Data Revolution

While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there is definite and significant progress being made in the background.

Massive amounts of data are generated on a daily basis through wearable devices, electronic health records, social media, clinical trials or spontaneous adverse reaction reports. There is no doubt that insights derived from this data will increasingly be used by regulators to assess the benefit-risk of medicines across their whole lifecycle. However, in order to benefit from and make prudent use of the data collected, regulators need a deeper understanding of the data landscape.

Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ (extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends and associations) in support of the evaluation and supervision of medicines by regulators were published recently as part of a summary report of the “Heads of Medicines Agencies (HMA) - EMA Joint Big Data” task force. The recommendations and associated actions set out what needs to be addressed, but the mechanisms by which this may be achieved requires further focused work over the coming year.

In parallel, on the IDMP front the latest achievement is a major overhaul of the ISO/TS 19844 “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances” which provide details on the data elements specified in ISO 11238 (“Data elements and structures for the unique identification and exchange of regulated information on substances”) for agencies and vendors working on the substance repositories (such as G-SRS at the FDA or the substance repository at EMA).

While the health authorities will ultimately define the standards for both the data and method of exchange, there is an opportunity for industry to identify its own method of data exchange. For example, the data supporting the development of a product across the life cycle is not only shared with the health authorities for approval, but it is also shared with partners, country affiliates, investors, and other invested parties. Implementing industry standards for collaboration with external sources where agreements of exchange, compromise, and promises are validated and released through protocol using for example blockchain technology is possible.

In a typical regulatory environment, content supporting a product from investigation to post-marketing approval and registration in a global landscape can be contained in anywhere from one to many systems. This can result in a series of challenges, including:

• data and content duplication

• the intent of purpose/definition could vary

• the quality of the data could be questioned

• it adds complexity to the reuse and distribution of the content

• during a merger or acquisition, it could be more difficult to harmonise these data sources with the acquiring company’s system.

The life sciences industry is entering a data revolution that is inevitable and otherwise semi-forced by the technological advancements over the past 20 years. The ability to garner command and control of dispersed data with various owners and intended purposes across the complete product life cycle and well into post-marketing activities is now possible for the first time through blockchain technology and coupled with the functions of AI and robotic processing automation (RPA).

Understanding the regulatory landscape, both past and future, and the drive toward data transformation and standards, provide the framework for the implementation of emerging technologies and overall environmental improvements. This direction will hopefully enable the life sciences industry to expedite patients’ accessibility to products, enhance safety, and improve decision making for both business and individual needs.