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Less Is More – and other lessons from the regulatory frontline

Written by Andrew Marr on 03/04/18

Following his recent retirement from life sciences regulatory consultancy, former consultant Andrew Marr reflects on 30+ years in the industry

A few months ago I hung up my hat after more than 30 years advising on processes around regulatory document management, submissions and data in life sciences, giving me cause to reflect on some milestone changes I have witnessed over that time.

The road to electronic submissions

At the beginning of my career marketing authorisation applications happened manually, on paper - involving massive photocopiers, page numbering by hand, and individual submissions for each market. The internal records being kept by companies at that time were very lightweight, so it was difficult to do anything of value with it. The data being kept routinely was limited as data gathering, and storage were expensive. The most definitive records tended to exist at a national level, but these were difficult to share - so teams struggled to know what had been approved/what was on the market. And if any information changed, it didn’t necessarily follow that all the right people would know.

In time, electronic formats were accepted, promoted and have become routine. The concept of centralised information systems has become commonplace, but the ability gather information has been inefficient and exchange information has been limited. But now the emphasis has begun to shift from static PDF files to something more granular that’s easier to index, categorise and search.

But of course none of this happened quickly. First, companies had to address their internal document management; the next step was to get the regulators to accept documents electronically – with all of the promise of savings on printing, logistics and so on. Including experimentation with different formats, this whole process took more than 10 years! Even when the eCTD standard was embraced widely, there were different regional flavours and approaches to implementation.

 

The emergence of RIM

By 2008/9, when electronic submissions began to be the de facto method for centralised authorisation processes, for Regulatory Affairs departments, regulatory information came into focus as distinct from just finished documents.

Developments in technology and the availability of more affordable storage, coupled with a growing desire for efficiency and re-use, prompted interest in the creation of a central database – what we now recognise as regulatory information systems (Reg IM or RIM). The idea was to collate and maintain as much information as possible, without too much cost or complexity. It wasn’t yet the Holy Grail, because data had to be extracted from documents, rather than everything starting from a master source. But this development offered to save companies some time and provided a useful repository for product information.

Early attempts at RIM systems were not especially user-friendly however, and a lack of standards meant that each company developed its own approach. But firms recognised this was something they needed to bring order and greater efficiency to their regulatory information efforts.

Seeing the value in data over static documents, regulators are also developing an appetite for a more comprehensive approach to information collection. In the US, the FDA’s preliminary guidance on what is now known as Pharmaceutical Quality/CMC, was quite rough and ready, but the intention that emerged was clear – the authorities wanted data.

 

From documents to data

Fast forward to today and the industry is now finalizing the criteria for ISO IDMP, which recognizes and demands comprehensive, good-quality data submission as a priority. This has been a tough set of requirements to perfect, because of the perceived importance and potential use cases for centrally published product data.

Frustratingly, many companies are still waiting for the Is to be dotted and the Ts crossed before they adapt their data management processes to the degree that will ultimately be needed. It has tended to be the more enlightened companies, or those with vast operations, that have seen the value in proactively reshaping their strategies ahead of time – understanding that this will make life easier for them in the long run.

I’ll pick up this theme in my keynote presentation at AMPLEXOR’s Be The Expert conference - projecting ahead to how regulatory information management will look in 5-10 years’ time and how advances such as machine learning will drive greater efficiency in RegIM.

I look forward to seeing you in Croatia! 

 

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Topics:
ISO IDMP, Regulatory Information Management, Life Sciences






Andrew Marr

Written by Andrew Marr

Leading consultant on XEVMPD and IDMP, consulting with many pharmaceutical, services and software companies. Active member of the ISO committee that developed the ISO IDMP standards. Former member of ICH M2, heavily involved in the development of the current eCTD specification and M2 Rapporteur, leading the group during the development of the requirements for the new version of the eCTD.

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