Regulatory affairs are the norms, rules, and procedures created to set limits on the work done by companies in various sectors.
These rules can be established by government agencies, regulatory entities, or even by the companies themselves. These compliances are the laws, regulations, and guidelines specific to each industry.
See how regulatory affairs help maintain quality in various areas of activity and understand how to maintain control over them in an efficient and automated way.
What are the main sectors with regulatory affairs?
Regulatory affairs are more present in areas of the market where there is a great need for legislation, regulation and control over what is being produced (and how it occurs).
You can certainly imagine what types of areas fit this profile: health, finance, and food are some examples. Below you can learn about the most common ones and understand their main regulations.
Pharmaceutical and Medical Device Industry
The most frequent regulatory issues in the pharmaceutical industry are related to the approval of new drugs and medical devices, safety monitoring (drug effects), clinical trials (testing of new medications), and good manufacturing practices.
Food & Beverage
In the food and beverage industry, the types of regulatory affairs involve the control of food safety, standardization in product labeling, the use and identification of food additives, and production practices.
Environmental
For companies in the environmental sector, there is a great concern with regulations on pollution, waste management, gas emissions, conservation and use of natural resources, and the general environmental impact that an activity can have on an area.
Finance
The most common regulatory issues for companies in the financial sector include rules and legislation that regulate activities such as banking, investments, insurance, audits, and anti-money laundering.
Technology and Telecommunications
In this segment, regulations are considered more recent and involve data protection, privacy, telecommunications regulation, and the cybersecurity of users.
Energy and Natural Resources
The main regulatory issues related to companies in this field provide guidance on the use of natural resources, the use and transition between renewable and non-renewable energy, as well as other sustainability issues.
Occupational Health and Safety
Finally, companies and areas of occupational safety and health usually have legislation to ensure the well-being of workers, prevent accidents, and avoid (or at least mitigate) exposure to hazardous substances.
What are regulatory agencies?
As you have seen, these regulatory standards affect several companies in the most varied segments — but who is responsible for creating and supervising these rules? Generally, this is the responsibility of regulatory agencies.
They can be defined as entities responsible not only for regulating, but also for inspecting and ensuring the proper functioning of various sectors of the economy.
That is why regulatory agencies are so important: they supervise essential activities for society and ensure compliance with good practices, legislation, and standards (such as ISO 45001).
Some of the main regulatory agencies are:
- Federal Drug Administration (FDA): US government body that controls food (both human and animal), dietary supplements, medicines (human and animal), cosmetics, medical equipment, biological materials and more.
- European Medicines Agency (EMA): This agency regulates the scientific assessment, supervision, and control of the safety of medicines for human and animal use in the EU.
- Medicines and Healthcare products Regulatory Agency (MHRA): This agency regulates medicines, medical devices, and blood components for transfusion in the UK.
- United States Department of Agriculture (USDA): Regulates agriculture in the United States.
How do regulatory affairs appear in practice in companies?
Regulatory agencies create the standards and guidelines that must be followed if a company wants to maintain quality and compliance in its activities.
But companies should not follow these guidelines just to have quality and produce better products or services. They are legal prerequisites for companies to be authorized to operate.
Therefore, companies now have sectors dedicated to regulatory affairs. This area is responsible for connecting organizations to agencies, facilitating the adoption of rules, good practices, and even bringing feedback and points for improvement about them.
Among the main attributions of a regulatory affairs sector are:
- List the regulations that need to be followed and disseminate them within the company;
- Adapt all processes related to a certain product or service that is under legislation or standard;
- Obtain the necessary registrations and certifications for the activities;
- Renewing these registrations/certifications, when necessary;
- Document all activities and practices related to regulatory affairs;
- Keep an update on new good practices, legislation and standards that may come into force;
- To supervise compliance with the rules within the company;
- Propose new laws/guidelines, both in relation to internal laws and those created by regulatory agencies.
How to adapt to a regulation?
In addition to having an internal regulatory affairs sector, every company that seeks to comply with the rules of regulatory agencies goes through a standard process that aims to assess whether everything is as expected.
Although some steps may vary according to the agency and the company’s area of operation, there is a general logic that applies most of the time. Below you know the three main steps to have an operation that complies with the standards and guidelines of a sector.
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Authorization and certification
To start the activities, the first step is precisely to get the necessary authorizations. In other words: your company must comply with applicable laws and be regularized by the relevant agencies.
For example, a company that produces and sells food must be registered with ANVISA, which in turn requires following its guidelines.
It is at this moment that an audit takes place to verify that everything is in the necessary compliance. For this, the regulatory affairs or compliance sector needs to understand all the laws and requirements of the regulatory body/agency and make the necessary adjustments.
Only then will your company receive the authorization and then be able to start the operation.
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Manufacturing
Once you get a license, it doesn’t mean that the regulatory affairs team’s work is complete. After all, it is not enough to have the authorization, it is necessary to ensure that the day-to-day work follows the necessary rules and guidelines.
Therefore, the sector is responsible for inspecting production, ensuring that it occurs in accordance with the determinations of regulatory agencies.
In this way, your company has peace of mind that it is in accordance with the specific requirements of the sector and the regulatory agency. In most cases, this involves the quality, safety, and effectiveness of the products/services.
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Maintenance
This last part is not exactly a step, but rather a process of continuous improvement. In maintaining compliance with the standards of regulatory agencies, everything is constantly audited, inspected and, if necessary, appropriate.
To implement this care, conduct regular internal audits and stay informed about changes and revisions to certifications and regulations. That way, you’ll avoid non-compliance—and keep your license.
How best to manage regulatory affairs?
You’ve already realized that it’s critical to manage regulatory affairs to achieve compliance, particularly for companies in highly regulated industries. However, even though it is crucial, many companies do not pay the necessary attention to it. The reason is simple: taking this care is quite difficult.
So that you don’t make the same mistake, we’ve separated three simple but very effective tips that will make the compliance process much more agile and reliable.
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Have a structured sector
The first step is not to try to reinvent the wheel or build something crazy at first. Start with the basics: structure a sector with exclusive dedication to the control of regulatory affairs.
It can be an entire department or a team allocated within the Compliance area. Everything will depend on your infrastructure and needs.
In the case of companies with a high volume of regulations, it is advisable to have a robust regulatory affairs management team. Otherwise, a leaner group can do the job.
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Maintain review practices
After implementing a team dedicated to regulatory affairs, create practices and routines for managing and enforcing regulations. The same goes for your eventual updates.
This serves both to know if activities and practices are really in compliance with laws/standards and to keep up with news and reformulations created by regulatory agencies. And remember to document everything and make that documentation available to all stakeholders.
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Use a compliance management system
Finally, the golden tip is simple: use technology to your advantage. If you’re keeping track of tasks, updates, and regulations in a simple spreadsheet (or, even worse, with pen and paper), you need to get up to speed.
With a compliance management system, for example, you can integrate several tools and features into a single solution that can be used by different teams within your company.
This way you gain agility and autonomy, in addition to ensuring that all parties involved are on the same page.
With a system of this type, it is still possible to automate tasks and even have a pre-configured structure. So you can comply with the most popular regulations, such as ISO, with minimal effort.
Conclusion
Now you not only understand what regulatory affairs are, but you also know the main regulatory agencies, how they relate to companies and how your company can manage these standards safely and safely.
For more tips on optimizing your company’s operation, keep an eye on the SoftExpert blog!
