At Inter Scientific, we believe that product regulation is a positive step towards protecting public health and ensuring that products on the market are safe and work as intended. Therefore, we support the introduction of regulations with the industries we support; pharmaceuticals, medical devices, nicotine, cosmetics, novel foods and consumer goods.

However, sometimes the regulations aren’t clear, or regulatory bodies are not adequately prepared for the numbers and variety in submissions. In this article, we’re looking at how regulatory authorities can improve their regulatory procedures to make compliance easier for product owners, themselves, and most importantly, the public.

Early engagement with a variety of appropriate industry experts and key stakeholders will help regulatory authorities to ensure that planned regulatory requirements are both relevant and in the interest of public health. This engagement can be continued throughout the regulation rollout to identify potential areas of concern and improvements to help the implementation of new regulations run smoothly.

This also has the effect of reassuring brand owners that new regulations are in their interest and are not intended to damage their business, which reduces the risk of hostility and rebellion against the new regulations.

By publishing definitive submission requirements and guidelines (and as the regulation becomes more ‘mature’, examples of previously approved submissions), there is a better chance that every submission they review is standardised, thus helping brand owners to:

While there’s no surefire way to know how many submissions will be received, regulatory authorities could engage with the relevant industry experts and key stakeholders to gain a better understanding of how many of them intend to submit regulatory applications and be able to determine internal staff requirements more accurately, for example knowing in advance that an increase in staff and training will likely be required and prepare appropriately, with plenty of time.

Regulatory authorities could also take measures to ensure that the technology used to accept submissions is both user-friendly to enable smooth and easy submissions for brand owners and to reduce the risk of technical issues and brand owners making multiple submissions.

While brand owners understand that processing their regulatory applications will take time, it makes sense that they are eager to know when their submission will be reviewed so they can move forward with their business.

Publishing regular updates on progress would be helpful for both brand owners and regulators, as brand owners would be able to gain an understanding of the process and set expectations for when they will receive a response, reducing the number of calls and emails authorities receive from brand owners requesting updates.

It’s important that regulatory enforcement agents are fully trained and kept informed about the details of regulatory requirements, particularly in newer, emerging industries where they may not understand the products yet.

This will mean that brands are managed appropriately when it comes to regulatory compliance and are not unfairly penalised. Education and clear guidelines will make it easier for both brands and enforcement agents to ensure that regulations are followed diligently.

The minute that regulations are announced regarding any product, uncertainty is created throughout the supply chain, who need to know how the new rules will affect their business.

In addition to this, the public, particularly consumers of the type of product in question, will start to question the safety and legitimacy of the products being sold, which can also have a negative impact on the brand owners.

Therefore, it is important for regulatory authorities to control the message communicated to both the industry and consumers.

There are many ways for regulatory authorities to improve the implementation process for new product regulations for themselves, brands and the general public. Most of these come down to simply preparing ahead and engaging with stakeholders to ensure that all  parties have a clear understanding of regulations and feel that their voices are being heard.

Need support complying with the regulations in your industry? We can help. Click here to learn about what we do or contact info@inter-scientific.com.

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