How can regulatory authorities improve implementation of new product regulations?
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 industry to define the regulations
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.
Clearer submission requirements
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:
- Evaluate the cost vs. benefit of going ahead with the regulation upfront
- Supply all relevant information, in the correct format and get their applications approved first time
- Achieve a quicker turnaround time for submission
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.
Keeping brand owners and consumers up to date
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.
Educating enforcement agents
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.
Maintain confidence throughout the process
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.