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Regulation in life sciences: Where are we and what’s on the horizon?

28/01/19

As the life sciences industry advances at pace, so too does the regulatory environment in which it operates. In recent years we’ve seen an increasingly complex landscape of regulation in life sciences, with changes in science and technology creating opportunities as well as challenges when it comes to working in the industry. In 2018, many life science organisations continued developing risk and compliance initiatives despite ongoing regulatory uncertainty. The 2017 introduction of new EU regulatory requirements took hold, and increased scrutiny was placed on data security and patient safety, particularly as medical devices became more connected. So what’s the state of the life sciences regulatory landscape now, and what can we look forward to in the future?

Current challenges for regulators

Regulation in the life sciences industry aims to not only ensure the safety and efficacy of products, but also to ensure innovative therapies can pass through investigative and regulatory processes as quickly as possible. The challenges of this are myriad, particularly as technology continues to develop and scientific breakthroughs change the way drugs and devices are manufactured. As more products become more complex, regulators must establish the best – and quickest – ways to evaluate them. These products include digital pills, connected medical devices and new molecular entities – all of which have the potential to improve public health if introduced to market safely and efficiently. However, constant innovation and development is complex, costly and time-consuming, and this is hampered further by increasing regulatory requirements.

All of this rapid development and change means the regulatory landscape must acquire new skills and talent in order to meet market demand and stay ahead of the curve. This is great news for life sciences candidates who are prepared to upskill and adapt to changes in the market.

Medical device cybersecurity ramps up

The scrutiny on protection of patient data hit fever pitch in 2018, and 2019 will continue to see an evolution in medical device cybersecurity. Last year it was revealed that more than half of providers lacked confidence in their medical device security, with nearly one-fifth of organisations experiencing malware attacks on medical devices. We’ve seen the FDA introduce a Software Precertification Pilot Program that provides regulatory guidance on assessing the safety of software technologies, and this year we should see a pilot programme launched to further streamline regulatory oversight of medical devices.

Closer to home, the GDPR has seen organisations across all industries pay closer attention to data protection and privacy. This has meant that within life sciences, organisations have had to secure both traditional IT systems and medical devices and ensure consent is obtained from patients before collecting and processing their information. While life sciences organisations should have already acted to ensure compliance with the regulations, ongoing work is required to ensure security is maintained as technology moves forward.

Regulators become more globally aligned

Regulation will become more cohesive across the board by 2025, according to Deloitte. Collaborative approaches such as co-regulation, self-regulation and international-coordination will see alignment on a national and international level. This will mean international agreements on rapid data sharing, databases that talk to each other and improved signal detection around the world. This harmonisation could result in drugs and products getting to market more quickly, as well as more patients participating in global clinical trials thanks to regulatory approval of tech-enabled clinical trial recruitment processes.

Technologies and robotics improve regulatory activity

Robotics are well and truly marking their mark on the life sciences industry now, and this will accelerate in the future. Deloitte predicts regulatory activity will be enhanced significantly by advanced technologies and robotics, with next-generation technologies introduced to enable automated processes and improved regulatory oversight. Regulators will have the ability to process more data faster, allowing them to make better regulatory decisions. Real time data will help regulators work more closely with the broader life sciences industry, particularly when it comes to clinical trials. Cloud technology, AI, machine learning and blockchain will have a much bigger impact on life sciences in the coming years, which will present new regulatory challenges for the industry.

Look to the future with Orion

Orion Group’s Life Sciences division places candidates in regulatory affairs roles, among others, all over the UK and Ireland. We’re always looking ahead to ensure our clients and candidates are on top of industry trends. Find your next life sciences job with us, or view our latest blogs for more industry insights.

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