Who or What is Regulatory Affairs?
Today we are going to look at the “Regulatory Department”, “Regulatory,” “Regulatory Affairs,” “Regulatory Agency,” “Regulatory Affairs”– individuals in Governmental Agencies and regulated industries who liaison between government, Industry, and consumers to help ensure that pharmaceuticals and medical products are safe and effective when used as approved.
Regulatory professionals are employed in Industry, government, and academia and are involved with a wide range of products, including:
- Pharmaceuticals
- Medical Devices
- In vitro/ In vivo diagnostics
- Biologics and Biotechnology, and many others.
People who work in Regulatory Affairs are responsible for the interface between the Regulatory Agencies (the health authorities), the Industry (i.e., Pharmaceuticals), and the Market (Commercial.) They enable “good” products available to the patients and keep them on the market while preventing bad or even harmful products from being sold. So, for example, the FDA, as a governmental regulatory agency, publishes regulations and guidance documents for the Industry in the Federal Register. These published materials are how the federal government notifies the public of their actions and why. FDA’s website, www.fda.gov, also contains links to the CGMP regulations. Current Good Manufacturing Practice regulations- guidance documents, and a variety of resources to help medical device and pharmaceutical manufacturers stay in Compliance with all legal requirements.
Government Agencies
There are many governmental regulatory agencies worldwide, each with evolving standards and legal requirements.
For example:
The guiding agency for the Pharmaceutical and Biotech industry internationally is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) https://www.ich.org/
In the US- the primary Federal governmental regulatory agency is the FDA, FDA | FDA (CBER) | FDA (CDER)
FDA (CDRH) | NIST
Canada has Health Canada
In the EU- there is EMA and, additionally, The Heads of Medicines Agencies HMA and European Commission Public Health.
The Medical and Healthcare Products Regulatory Agency (MHRA) is in the UK and
In Australia- Therapeutic Goods Administration
And, of course, in other countries worldwide- See the list with links at the bottom of this article.
The responsibility of the Regulatory Agency is to publish all legal regulations and resources for life sciences companies to ensure that these companies comply with the current guidelines. (See Queens of Quality Podcast S1 Ep. 1 “Quality and Compliance in the Pharmaceutical Industry” and September’s Blog on Quality and Compliance)
The Role of RA within a pharmaceutical company-The Regulatory Affairs department (RA) department of a pharmaceutical company is, in short, the strategist to ensure Regulatory Compliance. Remember, Compliance is always viewed as being “with” something- Compliant with the regulations. The Regulatory Department is responsible for coming up with those strategies. They take care of obtaining approval for new pharmaceutical products and making sure that approval is continued. They serve as the liaison between the regulatory authority and the project team. They are the main communication channel with the Governmental Regulatory Agency(ies) as the project progresses. They make sure that the project plan will anticipate what the Regulatory authority may require before approving the product.
It is the responsibility of RA to keep current on legislation, guidelines, and other regulatory updates and changes. Such rules and guidelines are often open to some flexible interpretation, and the regulatory agencies expect companies to take responsibility for how they interpreted them.
The RA department plays an essential role in advising the project team on how best to do that. During the development process, good working relationships with authorities are crucial, e.g., to discuss such issues as a divergence from guidelines, the clinical study program, and formulation development.
The RA department also advises on what will be reasonable for the intended product’s prescribing information (‘label’). As a project team member, RA also contributes to designing the development program. This core prescribing information is the basis for approval internationally and will later provide the platform for marketing. The documentation includes clinical trial applications, as well as regulatory submissions for new products and, perhaps most importantly, for changes to approved products. Another important RA task is providing input when legislative changes are being discussed and proposed.
This department reviews all documentation from a regulatory perspective, checking clarity, consistency, and completeness and that all conclusions are explicit.
What’s the current Landscape?
The range of products covered by Regulatory Agencies is enormous, including drugs, surgical equipment, in vitro and in vivo diagnostic tools and tests, and medical devices, etc… The range of issues addressed is also huge, such as manufacturing and analytical testing, preliminary safety and efficacy testing, clinical trials and postmarket follow-up, data management, document preparation, project management, and harmonization.
Over the years, a complicated system of checks and balances has developed to set in place a process to efficiently and effectively regulate the marketing of products. And that is the domain of Regulatory Affairs.
Even within the Industry, there is sometimes confusion about what “Regulatory” does versus Quality and Compliance. Or if regulatory requirements are the same for smaller organizations as for larger ones. The short answer is yes, but the long answer is a bit more nuanced. With the help of a consulting firm like Metis, your smaller organization may make strategic choices based on the company’s short-term and long-term plans.
Things have changed in recent years since the Polio vaccine was developed and, more recently, have become more agile and transparent since the global Covid-19 Pandemic. This has created some sea changes in the Industry. For example, while in the past it was not unheard of for people to have a hard time recruiting volunteers for clinical trials, Covid-19 brought tens of thousands of volunteers. The lockdown meant that many trials and procedures faced significant challenges mid-cycles. But on the other hand, the interest and availability of information to the public have brought a greater understanding of and appreciation for Quality, Compliance, and Regulation. The first-ever vaccine using mRNA technology came to market in record time while meeting ALL of the required Standards of Quality, Compliance, and Regulation. Just at a much-accelerated pace. Who knows what changes we will see in the Industry in the future as we see advances in Innovative Medicines, perhaps even including Precision or personalized medicine (although the market forces are tricky for that).
In Short, Regulatory is a vital part of any pharmaceutical or medical device manufacturer’s process. Training and leveraging the in-house team is essential to ensure that the consumer/patient is served safely.
For further information, See the “Queens of Quality Podcast.”
or to start a conversation https://linktr.ee/metis_consulting_services
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