Why is Regulatory Affairs important?

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.The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company.

Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost many millions of pounds, Euros or dollars to develop and even a three-month delay in bringing it to the market has considerable financial considerations. Even worse, failures to fully report all the available data, or the release of product bearing incorrect labelling, may easily result in the need for a product recall. Either occurrence may lead to the loss of several millions of units of sales, not to mention the resulting reduction in confidence of the investors, health professionals and patients.

A good Regulatory Affairs professional will have a ‘right first time’ approach and will play a very important part in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximise the cost-effective use of the company’s resources.
The Regulatory Affairs department is very often the first point of contact between the government authorities and the company.The attitudes and actions of the Regulatory Affairs professionals will condition the perceptions of the government officials to the company -for better, or for worse! Officials respond much better to a company whose representatives are scientifically accurate and knowledgeable than to one in which these qualities are absent.

The importance of the Regulatory Affairs function is such that senior Regulatory Affairs professionals are increasingly being appointed to boardroom positions, where they can advise upon and further influence the strategic decisions of their companies.