The field of regulatory affairs has taken on increased importance in recent years. This multidisciplinary field revolves around ensuring that certain products, mainly medical devices, pharmaceuticals, and food products, comply with federal safety regulations. The main goal is to assess these products to ensure public safety, confirm quality standards, and build consumer confidence. As more of these medical products reach consumers, making sure they are safe is more important than ever.

Rising compliance requirements and regulatory complexities have led to a large amount of growth in the global regulatory affairs market. Regulatory science professionals are in high demand, so it’s key to stay up to date on the latest trends and developments in the field.

Here are some of the predicted hot topics for regulatory affairs in 2026:

Growing Importance of Sustainability 

Environmental regulations have started to intersect more and more with regulatory affairs. Regulatory sciences professionals will need to give more attention to making sure that products are as environmentally friendly as they are health friendly. Regulatory environmental compliance is just as important, if not more important in our current climate. 

Green movements involving packaging materials, API, and carbon labelling are among the initiatives that RA teams will need to keep in mind when looking at products. The concept of “sustainability” has been rapidly gaining traction and importance in recent years, and it’s clear this momentum won’t be stopping in 2026. 

The Role of AI 

Artificial Intelligence (AI) has been a hot button topic on everyone’s mind in for the last few years and shows no signs of slowing down in 2026. The new technology has risen extremely quickly to prominence, but there are still numerous questions still about how much it should be utilized. AI can be very useful, however the potential consequences may outweigh the benefits. 

AI is making its mark on just about all fields of study, and regulatory affairs is most definitely one of them. It can be a helpful tool, but the use of it will require higher transparency, risk clarification, and a lot of oversight. It should most definitely be used with caution to avoid mistakes affecting the company’s credibility. 

On a global scale, the EU’s AI Act, the first legal framework for regulating AI use, has begun implementation. While the legislation only regulates certain uses of the technology, and is currently only in effect in the EU, it’s possible that it will only grow in 2026 and possibly become the global standard. 

Increase in Real World Evidence Use

Real World Evidence (RWE) refers to clinical data that comes from electronic health records and patient registries, as opposed to clinical trials. Just like trials, the data used to test and assess the safety, effectiveness, and value of medical products. Agencies such as the FDA and EMA are just now accepting RWE as a valid means for product pre-approval and post-market surveillance. 

While random trials will still be utilized, it seems the trend will be an increase in the use of this new methodology. There are still challenges to be worked out as far as ensuring data quality and integrity are concerned, as well as developing appropriate study designs to be able to use it. All of these will likely be addressed in the coming year, so RWE may be an industry standard soon. 

Getting a Degree in Regulatory Affairs 

With the market for regulatory affairs jobs growing so robustly in recent years, it’s important to find ways to stand out amongst applicants. A great way to do this is to earn a master’s degree in the field. Whether you already work in the regulations field or are interested in transitioning into it, this could be a perfect next step for you.

SDSU Global campus offers an online Master’s of Science in Regulatory Affairs that can be completed from anywhere, in just 18 months. With a career in regulatory affairs, you can go down a variety of different paths including clinical trials, drug development, food safety, medical device advancement, pharmaceutical research, and more. 

Former graduates of this program have gone on to work high-level positions at big name companies such as Johnson & Johnson, Bayer, Boston Scientific, Kimberly-Clark, and the Mayo Clinic. The curriculum is continuously being updated to include all of these new developments and trends. Plus, the coursework is fully online, so you’ll be able to apply the lesson you learn in your job as soon as the next day. Why wait? Apply today!