The phrase “regulatory compliance” is often accompanied by plenty of groaning, whining, and eye-rolling, particularly from the commercial and marketing department which would like to launch the product immediately and not be required to struggle with rules, regulations, checklists, and precise details. Regulatory compliance means an organization is aware of and aligned with (“compliant”) all the laws and regulations relevant to its business and industry. These regulations may be set at the local, state, federal, or international levels. Regulatory compliance offers several benefits for companies, which is why they must take it seriously. For one, an organization that achieves regulatory compliance can confidently indicate to its stakeholders that it has met specific standards and is certified by an industry-accepted regulatory body as having done so. In most companies, regulatory compliance is granted by the regulatory department, whose role is important since it allows the company to follow the rules and regulations invalidity, assuring the quality and safety of the products it offers to its customers.
The regulatory department
As a discipline, regulatory affairs (RA) covers a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. People who work in regulatory affairs negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market and to keep them there while preventing bad products from being sold. The range of products covered is enormous, including foods and agricultural products, veterinary products, surgical equipment, and medical devices, in vitro and in vivo diagnostic tools and tests, and drugs (which range from small molecules to proteins). The range of issues addressed is huge, such as manufacturing and analytical testing, preliminary safety and efficacy testing, clinical trials, and post-marketing follow-up. Advertising issues, with a healthy dose of data management, document preparation, project management, budgeting, issue negotiation, and conflict resolution, are thrown in the mix. It is the responsibility of RA to keep abreast of current legislation, guidelines, and other regulatory intelligence. Such rules and guidelines often allow some flexibility, and the regulatory authorities expect companies to take responsibility for deciding how they should be interpreted. In the beginning regulatory activities were strictly linked to laws and regulation while now the regulatory function inside a company has greatly evolved. It does not have a simple administrative role, but it is important also in the strategy of the company, considering its important role in the launch of the products on the market helping to reduce mistakes, and accelerating the registration times. Creating a constructive and fluid dialogue with the various players in the company is essential to make processes more streamlined and effective.
Some of the responsibilities of the regulatory department are the following:
- Study and interpret the rules
- Constantly check the legislation and monitor any updates
- Ensure the registration and compliance of products on the market with the legislation of the territory
- Evaluate product registrability in countries of distribution
- Prepare and update technical dossiers and product regulatory documentation
- Prepare registration documents and carry out all the necessary actions to complete the registration of products abroad
- Mediate between authority needs and company needs
- Revise artworks and promotional materials from a regulatory point of view.
As it can be imagined, the regulatory department is essential in the creation process of a new product, since it allows to understand the characteristics that the product can have, and the process needed to be able to have the product on the market in the shortest possible time, being in contact with all company departments to allow the registration of the product on the market and the distribution of the product. The role of the regulatory is equally fundamental during the whole life cycle of the product when it is important to analyze variations that are needed on the products and their dossier and to implement the needed activities in order to allow the compliance of the product following changes of the normative. Thus, the RA department has multiple responsibilities and areas of expertise and is a connection point between different company dimensions. Its role is in constant transformation and has a much more dynamic nature than one might think at first.
A regulatory role for food supplement and medical device worldwide distribution
Food supplements are products that are not as strictly regulated as medical devices and drug products, and in which rules and regulations are not very often harmonized and can sometimes be keen to interpretation. In fact, regulations for food supplement approval, the type and quantity of ingredients allowed in these products, the information to report on the labeling and the process of registration to follow to introduce the product on the market and the related timelines can be very different from one country to the other. For example, in Italy, as in many European countries, in order to introduce a food supplement on the market a food business operator (FBO) needs to submit a notification of the product, together with its label to the Ministry of Health. If no feedback is obtained from the authority for a certain period, the FBO can start distributing the product on the market.
In this case, the role of the regulatory department is important in order to provide guidance on the rules that need to be followed for the composition of the product and its labeling since the responsibility of the product on the market is usually of the FBO. On the other hand, in other countries, such as Colombia or the Philippines the process and documentation requested is much more complicated and the timeline to obtain an approval goes from 6 to 12 months, making it extremely important to evaluate preliminary if a product can be registered and preparing the right documents to provide to authorities, in order to limit as much as possible eventual revision which would delay even more the approval of the product. Furthermore, not all countries have the same classification for these types of products so products registered as food supplements in Europe can be recognized as health products in some countries. In other cases, if certain ingredients are present in the products, the product can be even classified as a drug in some countries. Even at European levels, in which one would expect regulations to be harmonies, there are some differences between the ingredients that are allowed so sometimes it requires a continuous follow-up and preliminary analysis to be able to launch these products in many different countries. The medical device area is much more regulated also considering the recent introduction of the Medical Device Regulation 745/2017/CE in Europe. Key features of the device regulation are that the legislation sets out what is known as the essential requirements, the core elements and procedures that companies need to have in place; sets out and defines the conformity assessment process (how independent bodies will assess whether a device is in conformity with the directives), and lays down precise obligations on the part of manufacturers. In this case, the European system and the US system are similar and have a risk-based device classification system. In Europe, for example, there are three classes but four categories:
- Class I—self-regulation
- Class IIA—selective quality-system review (QSR)
- Class IIB—full QSR and targeted review of the design dossier
- Class III—full design-dossier review.
In the medical device area, it is important to have intense knowledge of the regulations and the specific applications for each country to be able to achieve product compliance and to have it certified according to local regulations. In fact, also, in this case, each country has its own rules to follow. So clearance or approval in one market does not necessarily translate to others. Even if both European certification and FDA approval of these products for example have a great validity during registration processes in foreign countries, there has been evidence in which products that have been cleared by FDA in the United States have been turned down or not taken forward by notified bodies in the EU and vice versa. A similar situation can be indicated for other countries. In fact, if you want to start distributing a medical device in Brazil you need to fulfill ANVISA requests even if the product is already approved by a European notified body; and again, for Saudi Arabia, SFDA requirements need to be followed to allow importation and distribution of a medical device. So it is important to be aware of the differences and additional requirements of each local authority in order to successfully reach the market.
Considering all these differences in the regulations and requirements of the different markets, both for food supplements and medical devices, it is easy to understand that a proactive and efficient regulatory approach can be the winning strategy to use to allow the success in entering one market and launching the product in the shortest and easiest way, always prioritizing also the compliance of the products with local regulations. In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success. A new product can have high development costs and even a three-month delay in bringing it to the market might have considerable financial considerations. Even worse, failures to fully report all the available data or the release of products bearing incorrect labeling may easily result in the need for a product recall. The proper conduct of the Regulatory Affairs activities is therefore of considerable economic importance for the company.