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Every company in the marketplace must comply with different rules and regulations if they want to sell their products. Regardless of where a company is located or what industry they operate in, regulatory compliance is non-negotiable. However, the sets of rules and regulations that companies must comply with to ensure their products are safe and efficient differ greatly from one industry to another. Regulatory compliance in healthcare, for instance, comes with its own unique challenges and multiplied risks.
Human lives are at the crux of the life sciences industry. The standards that govern product manufacturing in the industry set out to protect people. Although this may seem simple and straightforward, there are many challenges that add to the complexities that companies in this industry face.
Any manufacturer in the life sciences industry will tell you that what makes regulatory compliance so complex isn’t just the obligation of being compliant, but the layers of global, regional, and local regulations. Each regulatory agency has their own way of ensuring that the product is safe and that the benefits of the products outweigh the risks.
On top of that, these regulations are constantly changing and being updated.
Every step from Manufacturing, Design Control, Product Release and Post Market Surveillance are governed by rules and regulations. These steps are always subject to change and updates according to the regulatory authorities and country legislations. It is the company’s responsibility to correctly comply with each authority’s most current regulations.
As one can imagine, navigating the complex world of regulatory compliance in healthcare today while remaining profitable is quite the feat. The first step to unpacking regulatory compliance is determining the challenges that can affect companies the most.
This article is going to pinpoint where some of the main challenges of regulatory compliance lie, so that companies can overcome them.
Modern society is more connected than ever before through globalization. A prime example of that is how wide-sweeping the effects of COVID-19 were throughout the world. From global shipping delays to material shortages, the pandemic is a global crisis whose effects can still be seen two years later.
Despite the government lockdowns, the healthcare industry was busier than ever. Life sciences companies were forced to fast track product development. Expedited manufacturing of products quickly became the new norm.
However, regulatory compliance was still a reality. Companies had to quickly pivot their operations to cope with the unprecedented demands of COVID, while still remaining compliant. Companies were forced to adapt to the situation to get their products to market.
If the global pandemic has taught the life sciences industry anything, it’s that flexibility is essential. From a regulatory standpoint, flexibility in production, manufacturing, design, and product evolution is the key to handling crises.
Although this is particularly challenging in an ever-changing landscape, the utilization of advanced tools and management systems can help foster the flexibility needed to cope with unprecedented demands.
It’s no secret that every company in the life sciences industry has ambitions to go global with their products. But the challenge here is for companies to find an efficient way to do this.
For companies to get their products authorized, they must comply with the regulatory requirements in the various countries they intend to sell in. So, establishing a systematic mode of tracking and controlling products, while maintaining traceability for each specific market, is a must.
What’s the best way for companies to control their regulatory compliance for expansion into global markets?
The answer is simple: the best practice needs to follow the “red thread” of the product lifecycle. Companies need to be able to trace the product information from end to end. Specialized documentation needs to be a part of a company’s global expansion. That way, information can be reproduced and reused for each regulatory authority.
Efficient global expansion should really focus on the digital continuity of products. Product development doesn’t end with design, it rolls down through manufacturing, to the very last level of the product lifecycle process. In the digital world, there is nothing better than a digital solution that can effectively and efficiently manage this.
Another issue for companies expanding globally, in terms of regulatory compliance in healthcare, is the timing of product registration in each country. Once companies have a sophisticated Information Management System in place, it is much more convenient to deal with processing product changes across global authorities. No more waiting to make bigger changes or holding off on changes altogether.
Companies usually have a tough time interpreting regulatory requirements. Therefore, regulatory compliance in healthcare requires that companies decipher what regulations mean and which apply to them. Sadly, there isn’t a one-size-fits-all solution to this industry challenge. There are, however, certain tips that companies should follow.
Defining a regulatory strategy is essential to accurately understanding how to comply with regulations. Building an experienced regulatory affairs department should be at the top of a company’s to-do list. A company that understands regulatory compliance is one that can use its network to work together with regulatory affairs representatives.
The bottom line is that companies need to have the capacity to trace back issues that could come up with their products and have built-in strategies to quickly address them.
An added layer of complexity is that it is up to the authorities to interpret the regulations and decide whether a company’s documentation proves that they can do this in a safe and efficient way.
Finding digital tools and software that will help companies organize, structure, and trace their information is the only reliable approach to providing proof to the relevant authorities. If these systems allow companies to incorporate regulatory intelligence garnered from their established regulatory strategy, they will be even more effective.
Patient treatments are extremely personalized nowadays. Take cancer treatment, for instance. There are laboratory-developed tests that determines the biomarkers on a patient’s tumor and based on that, specific chemotherapy treatments are prescribed.
Over time, each patient has gained a voice, and regulatory compliance in healthcare today attempts to protect that voice. Now more than ever, products are precisely controlled to better avoid negative patient incidences.
That said, highly personalized products call for highly personalized post-market surveillance. It’s far too easy for companies to forget the patient once the product has been authorized. Post-market communication is an indispensable piece to each product’s overall success.
Often, more personalized products lead to larger company portfolios. So, transparent platforms and solutions to manage all of them effectively is fundamental to maintaining post-market surveillance.
To ensure post-market surveillance is managed, product development must include easy access to clinical evaluation reports. Establishing a system that has these types of solutions in place, before you start working on a new product or change, is the best way to cope with the post-market surveillance of highly personalized products.
The simple truth is that every company in the life sciences industry should be audit-ready at all times. That is much easier said than done. Especially given the differing rules between regulatory authorities and how quickly they tend to change.
Audit readiness is directly related to a company’s ability to manage changes during product development.
If a company can adequately manage changes from a documentation, manufacturing, and logistical standpoint, they are better prepared for the very real possibility of being audited.
Therefore, audit readiness really begins with product change assessment. Establishing a change management process that accurately assesses how efficiently a change can be made, and the implications of said change, is the simplest way to prepare for an audit.
In short, companies that make an effort to put a system in place that captures changes and product evolutions in an efficient way are more likely to get their products authorized without a hitch. Even in the case of an audit, with a Change Management System in place, it will be a faster one.
In terms of audit readiness, the best offense is a good defense.
Regulatory compliance in healthcare today is more complex than ever. The regulatory authorities on local, regional, and global levels are honing in on manufacturing processes to ensure patient safety. The main takeaway for companies should be to design processes that protect patients above all else. That means wading through the ever-changing regulatory complexity to maintain compliance.
The five challenges outlined above help to unpack what is really burdening companies in the life sciences industry. Regulatory compliance is at the heart of all of these hurdles. However, digital tools and platforms are the solution to help companies navigate these challenges and reduce time to market while remaining profitable.