What are regulatory affairs?

Regulatory issues are one of the main areas of attention for regulated industries, such as pharmaceuticals, cosmetics, medical devices, medical gases, food, sanitizers and others, which need to adapt to the determinations of regulatory bodies.

This area is essential to the own existence of these companies. Without the necessary authorizations, companies in regulated industries cannot operate.

What are regulatory affairs?

To understand what regulatory affairs are, you need to know the two main parts of this environment: the regulatory agencies and the regulated industries.

Companies in regulated industries

Every company that works with the manufacture, production, distribution or marketing of products that require health regulations – cosmetics, food, medicines and health and health products in general – needs to go through a legalization and registration process.

This is because companies in these industries work with products for human consumption, which, if left unregulated, can present major risks to public health.

As an example, the launch of a new medicine in a country needs to be extensively tested, both in terms of its safety and efficacy, to ensure that this product is suitable for consumption.

Thus, the role of regulatory affairs is to guarantee this safety throughout the production process and to legalize the company with the regulatory agencies.

Regulatory agencies

If all companies need to guarantee their security and compliance with the rules, the other part of the equation is defining what are these rules.

Agencies are government bodies that aim to guarantee the safety and efficacy of products from the life sciences industries through laws, guidelines and good practices that must be followed. In addition to creating guidelines, regulatory agencies also need to constantly implement mechanisms to ensure that these measures are followed.

In Brazil, the agency responsible for regulatory matters is the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency) (ANVISA). Only with the authorization of regulatory agencies can companies operate in the country.

Regulatory affairs - the connection between the two parties

The regulatory affairs sector is responsible for bringing the two parties together. Within companies, this sector needs to ensure that processes are in line with what is determined by the agencies. This is a legal, technical and very complex process.

We’re talking here about industries that move billions of dollars and need to be fully compliant with the regulations, otherwise they can’t operate.

The main functions of the area

Every regulated industry needs to be up to date with regulatory issues. Professionals in this field can come from a variety of backgrounds, such as:

• Pharmacists;
• biologists;
• nurses;
• doctors;
• biomedical;
• chemists;
• lawyers;
• economists;
• administrators, and many others.

In this case, it’s not just one professional per company, but a multidisciplinary team that needs to have specialized technical knowledge and an in-depth understanding of the legal process, and that can work both in regulated industries and within the regulatory bodies themselves.

What the regulatory affairs sector needs to do

We believe that so far we have seen how essential this sector is to the industry. The responsibilities of the regulatory affairs professional are many. The functions of this area include:

  • Make the connection between industry and the regulatory body;
  • Know the technical and legal requirements that need to be followed at national and international level;
  • Adapt the process of all products;
  • Obtaining the necessary registrations;
  • Paying attention to the deadlines for renewing registrations, submitting and complying with requirements;
  • Registering and maintaining all the company’s documentation.
  • Managing factories, equipment, storage and transportation of products;
  • Be updated with current legislation;
  • Advising other departments and companies on health requirements;
  • Monitoring compliance with laws and guidelines;
  • Proposing new laws and guidelines;
  • and much more.

This professional is key within the company. A regulated company cannot exist – literally – without a team looking at this sector.

Regulatory issues in practice

The regulatory process can be divided into 3 stages: approval, manufacture and maintenance.

Phase 1: authorization and certification process

The approval phase comes first. During this period, the company needs to be legally regularized and registered with ANVISA or the Ministry of Agriculture, depending on its sector of activity.

If it meets the legal requirements, the company is authorized to start operating in Brazil.

Phase 2: manufacturing process

After approval, the work becomes more operational. At this stage, the industry begins production, which must take place in accordance with the determinations of the regulatory bodies.

Phase 3: maintenance process

The third phase never ends. Processes need to be constantly audited, inspected and adapted for as long as the product is manufactured.

The importance of the area within the industry

The importance of regulatory affairs for manufacturers

Regulatory issues are part of the routine for any manufacturer of regulated products. Without complying with the law, he cannot market his products in the country.

There is also the risk that this manufacturer, even after having been authorized to produce, will be penalized if it begins to break the law. In addition, new rules are created and new standards are constantly being adopted.

This shows how the work continues and needs constant maintenance. To this end, companies have fixed teams for this type of function, given the level of importance.

Importance for governments

Articles 196 and 197 of the Federal Constitution guarantee that it is the responsibility of the Brazilian State to provide and maintain public health services. Among the government’s responsibilities is the creation of “[…] social and economic policies aimed at reducing the risk of disease and other health problems […]”.

In regulatory matters, the Ministry of Health, through ANVISA, is responsible for ensuring that safety measures are created, respected and inspected all companies.

Importance for the consumer

Although most consumers don’t know about regulatory issues, they are more important than you can imagine. Consumers are the main targets of regulated products, and their own health depends on it.

Imagine if there weren’t strict regulations on the food and medicine industries. There would be no guarantee of biosafety, and the end consumer would be the most affected.
For these reasons, regulatory issues are among the most important points when it comes to the health, safety and quality of regulated industries.

How technology is revolutionizing the sector

What companies in regulated industries need is management solutions. Managing records and factories and ensuring that everything complies with the law is not a simple task. These are deadlines that need to be met, records that need to be renewed and data that needs to be keep safe.

Even so, many companies still use spreadsheets as their main way of organizing data. As useful as they are, in a business that leaves no room for error, this is not the best strategy.
The main problems with not having the most up-to-date tools are:

Risk of missing renewal deadlines and complying with requirements;
• Decentralized data;
• Effort to combine information and generate indicators;
• Limitations in organizing information and managing access;
• Compromised data reliability, integrity and confidentiality;
• Loss of important information;
• Human error;
• Lack of auditing and transparency in data management;
• Lack of visibility on demand planning and demand peaks.

Thinking about the sector’s needs, Organex created RAS, the Regulatory Affairs System. More security, simplicity and efficiency for the regulatory affairs sector. If you want to learn more about the benefits of a specialized system in our website, click here!

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