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The New Regulatory Affairs World!

November 12, 2015

by Ben Hobbins

Smart hand holding the globe

In the fast paced world of regulatory affairs, there have been a number of changes in the way that the profession works. I’ve been interested in the main catalysts of these changes. To gather this information I have reached out to a number of my senior global regulatory leader friends who are internationally based, have significant experience in the industry and have witnessed these changes first hand. I would like to express my deep gratitude to all who supported me with this article. Truly thank you!

1. Globalisation

These days, more and more businesses are endeavouring to implement global harmonisation – it’s literally become a buzz word in the industry. Health Authorities do not wish to deal with multiple regulatory teams in multiple affiliates, along with differing standards and procedures. They want to deal directly with the pharmaceutical company and with one point of contact. They want a unified voice where everyone is of one mind and follows the same best practice. With each country following and developing their own unique regulatory requirements, harmonising them makes huge sense. In fact, the simplistic beauty of this new global approach is that it provides the opportunity to learn from one another and implement best practice.

The danger, however, can be in either trenchantly adhering to the same processes or to emphatically insist on local variation. You can find that everyone is operating in a silo or, the opposite, where everyone is forced to do the same thing whether or not it is effective. I would propose a middle ground. It’s also worth taking in to account the fact that the regulatory functions of small and large organisations are organised in very different ways. Does the company have a single office, multiple affiliates, or are they outsourcing parts of their regulatory function? In the past, it was very difficult to do things internationally. Now, however, companies are used to conferencing with each other and communicate using matrix functions across multiple locations.

2. The IT Revolution

Currently there are a large number of regulatory IT systems available that, to a degree, provide the same function. As a result of ever increasing connectivity, company growth and mergers and acquisitions, it might make more sense to have one tool that fits all needs. This will improve communication, effectiveness and reduce costs. Why use four tools when you only need one? There has been a dramatic shift in the last 10 years. In the mid 90s, companies were dealing with vast volumes of paper held in binders. To compound this, there were multiple copies of these same documents and these had to be loaded into trucks and moved around! When using paper based documents it was difficult to search specific parts of a submission and often key information was missed. This was followed by a considerable time scanning and digitalising data. The hard work involved has literally been life changing for everyone involved. All the key information is quickly accessible and this has been tremendously helpful for all, apart perhaps for the truck drivers..

3. Pricing Pressure

There is more and more pressure on pricing. At first glance this downward pressure on pricing might seem to be a good thing for patients but it is now much harder for smaller companies to obtain investment in serious R&D development.

In the past, Regulatory Affairs avoided to a large degree getting involved with pricing. They were focused on three hurdles: 1. Quality, 2. Safety and 3. Efficacy. Now unfortunately there is a fourth hurdle and this is pricing. As we all know, even if a health authority approves a drug it may still not reach patient hands as governments may not be prepared to pay for it. Enter the recent growth in pricing, reimbursement and HEOR professionals. As someone who is in constant communication with multiple companies, I can tell you these teams have been growing fast over the last few years. Since 60-70% of P&R dossiers are taken from regulatory dossiers, it might even make good sense to combine both disciplines into one new function ‘Regulatory/Pricing & Reimbursement’.

The pinch on pricing has also played well into the hands of CROs, as more and more companies have outsourced their regulatory work in order to bring down costs. This has generally been for established products as companies still prefer to keep strategy and development internal.

In short, pricing cuts have forced pharmaceutical companies to cut down on staff. They have been required to outsource their regulatory work externally, reduce their R&D activity and, finally, to greatly limit the available time of regulatory professionals to keep themselves up to date with the constantly changing regulatory environment.

It’s a much tougher job than it used to be 10 years ago.

4. How might Regulatory Organisations Look in 10 Years’ Time?

At present the US and countries in the EU have similar regulatory guidelines in place but when it comes to emerging markets there are fewer similarities. In ten years’ time, these emerging markets will probably catch up and have more harmonised approach. We might even see the day when guidelines across the whole world are the same. (This probably won’t happen for another 100 years though!) Regulatory departments might become smaller and become much more of a strategic partner focused more at the top level. Hopefully as a result of more synergy and standardised guidelines internationally, there will be fewer people actually involved in hands-on authoring work. Years ago Regulatory teams were relatively small, but over the years they have grown larger and larger with ever more distinct skill sets. In the future they will probably start to shrink again. It might also be the case that QA and Regulatory departments enjoy more of a separation, as Regulatory gets less and less involved in compliance activities. Hopefully more effective IT solutions will make the whole application process more straight forward.

In summary we can see that over the last 10 years, the role of the Regulatory Affairs professional has become ever more challenging. At the same time, as we move forwards, we can predict a shift towards simplification of processes which would be of great benefit to all.

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