Regulatory Information Management Systems/Software, or RIMS, are platforms that have emerged to assist pharmaceutical companies and medical device manufacturers in submitting products for regulatory review. As one of the most regulated industries, pharmaceutical and medical device manufacturing requires constant regulatory approval of new products. While not as consistent as the industries need to document compliance in the manufacturing process itself, submitting new products for approval is still a regular enough occurrence to be a drain on resources.
The regulatory approval process is also significantly more complicated than proving ongoing compliance and can potentially have greater financial implications if not done properly. If a new drug or device is rejected, it can take months or even years to successfully reapply and have it be approved. Given that the final approval rate for new drugs is only around one in six, avoiding unnecessary rejections is vital to maintaining the cost-effectiveness of research and development. This makes eliminating errors in the submission process absolutely crucial, which is where RIMS comes in. In this article, we take a look at the origins of regulatory information management software and examine how it helps to safeguard against failures in the approval process.
What is Regulatory Information Management?
Regulatory management broadly refers to the processes put in place to manage the collection, organization, and submission of information pertinent to the regulatory approval of new products. More specifically, it is most commonly used to refer to the approval process of new human medical products, including pharmaceuticals.
Regulatory information management has existed in some form since human medical products were first regulated. However, the standardization of the process which exists today was formulated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2000. In a collaboration between the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other ICH members, a common set of documentation for approval submissions was created. This is known as the Common Technical Document (CTD).
Most commonly referred to now as the eCTD (Electronic Common Technical Document), the Common Technical Document is an attempt to make the process for new product submission relatively seamless across different geographic areas and regulatory bodies. However, there are still variables, with some agencies requiring eCTD and others just allowing it. In fact, “Module 1” of the CTD is simply a variable module. It is not actually part of the CTD, allowing for regional administrative differences. Additionally, the eCTD does not cover medical device submissions at all. Therefore, the submission process for new medical products remains fairly complex, which is why regulatory information management, particularly RIMS platforms, are essential.
Regulation vs Compliance
At this point, it is important to take a brief moment to examine the difference between regulation (and regulatory approval) and compliance. While the two are, of course, closely related, they represent two separate sides of the system of quality assurance and safety in the pharmaceutical and medical device industries.
Regulation
As a general definition, regulations are just a set of rules and guidelines that are enforced by some kind of body, most commonly a government agency (such as the FDA). They are generally put in place in response to some kind of incident which highlights the need for a level of oversight or control of a specific industry or sector. As such, they tend to be aimed at protecting either people or the environment from potential negative impacts from employers, manufacturers, service providers, educators, or healthcare professionals.
Regulatory approval refers specifically to the manufacturing sector. As touched on above, this is the process whereby manufacturers receive the stamp of approval for a new product to be sold on the market under a specific, regulated product category (most commonly pharmaceuticals or medical devices).
Compliance
Regulatory compliance is the ongoing process whereby a business meets the requirements set forth by the regulatory authorities that govern their industry. Being “in compliance” is not a binary for an entire organization or business. Rather, certain processes and actions taken by employees are either in compliance or not. Most businesses are also governed by multiple sets of regulations, including ones that refer to manufacturing standards, employee safety, environmental safety, and more. Therefore, a business may be in compliance with one set of regulations but out of compliance with another.
In the pharmaceutical and medical manufacturing industries, compliance is massively important. After a drug or device receives regulatory approval, all production of the product (and the documentation thereof) must meet the rigorous standards laid out in the FDA’s 21 CFR Part 11legislation. This allows the FDA to easily ascertain whether the quality of manufacturing which received approval has been maintained and adequate safety measures are in place.
What Does Regulatory Information Mean?
As discussed briefly above, regulatory information refers to the information that must be provided by a producer or manufacturer of goods intended for human medical use or consumption in order for their new products to be submitted and processed for regulatory approval. In the US, that information will always be submitted to the FDA, either in the form of an eCTD or a 510(k) submission.
In both of these cases, barring a few areas of variation, the content of the submission will be largely similar. The goal, particularly in the instance of pharmaceutical and other human medical products, is to ascertain the pre-market safety and efficacy of a product before issuing regulatory approval. Naturally, this involves the collection and submission of significant amounts of data and documentation, all collected and handled within the Good Practice (GxP) guidelines. For eCTD submissions, the required information is broken down into modules.
eCTD Breakdown
Module 1 – Regional Administration Information
- Module 1 is not technically part of the eCTD and actually serves as a placeholder for the regional variances that exist between agencies.
Regulatory Information Management Software
So, what is a RIM system? It should be clear at this point that submitting new human medical products for regulatory approval is a complex process, even with the advent of the eCTD. This is particularly true when submitting a product to multiple different regulatory agencies and regions, which is usually the case. Therefore, proper regulatory information management is vital to minimize the risk of rejection and, subsequently, delays and financial losses associated with being late to market.
Regulatory information management software, or a RIM system, is not only the easiest way to ensure that the process is being handled correctly, it is an essential component. The FDA no longer accepts non-eCTD submissions, meaning that a digital version of your submission dossier is required. This can be manually generated, but that is labor intensive and completely inefficient, opening up the door to increased risk of human error. While there are specific RIMS platforms, most good records and information management platforms which have a pharmaceutical-specific offering will include an integrated regulatory information management system. This means that your regulatory compliance data can all exist in the same ecosystem, moving seamlessly through non-clinical and clinical to approval, manufacturing, and distribution.
Summary
Regulatory approval is a crucial part of the drug and medical device research, manufacturing, and distribution pipeline. Without it, manufacturers cannot bring their products to market. Despite efforts to streamline and standardize the process across regions and industry segments, there is still a vast amount of variance and complexity that needs to be accounted for in the submission process. Failure to do this properly can mean significant delays in going to market, or even outright rejection of approval.Proper regulatory information management, using an industry-ready regulatory information management software platform, is vital to reduce the risk of human error and protect against new products having their approval delayed or rejected. By implementing a system that incorporates RIMS into your organization-wide records management, you can save both time and money while ensuring that your new product approvals are not hampered by unnecessary errors.