What is Regulatory Compliance? And Why it is Important in Pharmaceutical, Medical Device and Healthcare Industries?

14, June 2018

Understanding regulatory compliance and its importance in the pharmaceutical, medical device and healthcare industries is very crucial for regulatory professionals, and anyone connected with these industries, for a number of reasons.

Firstly, Discussion of Regulatory Compliance:

Regulatory compliance means being in accordance with the regulations set out by regulators. It is being in a state where the regulatory requirements are met to the fullest extent, as required by regulatory agencies. Meeting regulatory requirements is a prime requirement for everyone who is part of an industry that is regulated. These regulations are made by the regulatory agencies across the world, whose intention of making these regulations is to ensure the quality of products that are made by organizations in their industry.

Meeting regulatory compliance requirements is important for businesses in all sectors, but is of critical importance to pharmaceutical, medical devices and healthcare because of the reasons stated below. By complying with regulations set out by regulatory bodies; an organization in the pharmaceutical, medical device and healthcare industries gains the following benefits:

Eliminates Risk:

Another major benefit of compliance with the regulatory requirements is that organizations in the healthcare, pharmaceutical and medical device industries can identify, mitigate and eliminate risk at all stages. Risk elimination is one of the core purposes of regulatory compliance, and is built into the core of all processes. Regulatory agencies spell out clear guidelines on how to identify and mitigate risk. The processes suggested by the regulatory agencies act as ready reference for organizations that manufacture products.

Enhances Customer and Investor Confidence:

No product is likely to gain the trust from everyone who matters, right from the customers, stakeholders, employees and investors alike, unless it has met regulatory compliance requirements. Complying with regulatory requirements is the highest and surest guarantee and safeguard for the efficiency and efficacy of a product. When a pharmaceutical, medical device or healthcare company gains the trust of these vital players, it can be said to be valued company.

Saves Costs:

Yet another benefit compliance with regulatory requirements brings for companies in the pharmaceutical, medical device and healthcare industry is that it helps to save costs throughout the lifecycle of the product. High costs are associated with ensuring compliance, but the cost of noncompliance is multifold higher. If an organization discovers that it has failed to meet regulatory requirements at any particular stage; it is usually impossible to abandon work at that stage and start afresh. The cost is astronomical in such an exercise.

Having said this, it is not possible for such companies to give up their work at that stage, because it renders void and useless all that is done till then, leaving them in a typical Catch-22 situation. Further, products that fail to regulatory requirements cannot pass the test of regulatory approval. If they have to fulfil the penalty requirements of the FDA or other regulatory agencies; the costs spike up no end. So, meeting regulatory compliance requirements at every stage is the safest and most economical option for a company in the pharmaceutical, healthcare or medical devices industries.

There is no alternative to meeting regulatory compliance requirements by pharmaceutical, medical devices and healthcare companies

Given the nature of regulatory compliance, the importance of regulatory compliance to pharmaceutical, medical devices and healthcare becomes clear. All these three industries have much in common, but the most important commonality is that they all play a critical role in ensuring health and wellbeing of people. It is unthinkable how pharmaceutical, medical devices and healthcare can be seen to serve any purpose other than this.

This is where the importance of regulatory compliance to pharmaceutical, medical devices and healthcare needs to be understood, because no other means ensure the wellbeing and health of people than regulatory compliance. We have just examined how regulatory compliance is essential and indispensable to make sure that the processes and products in these industries meet quality standards. When the products in these industries comply with regulatory requirements, it ensures that they are of high quality standards, which in turn is the sole means to seeing to it that human wellbeing is ensured. It is in this context that the importance of regulatory compliance to pharmaceutical, medical devices and healthcare needs to be understood.

The main purpose of regulatory agencies around the world, such the FDA, the EMA and others, is to make sure that the pharmaceutical, medical device and healthcare industries deliver the best products to the people who use them. This is never going to be possible unless the companies that make these products adhere to the regulatory compliance requirements set out by these agencies. This is how one can get an idea of the importance of regulatory compliance to pharmaceutical, medical devices and healthcare.