Crucial considerations in regulatory affairs

Why is it so important for Life Science companies to invest in regulatory affairs activities as part of their drug development programs? What are the challenges and the key aspects for success?

What is regulatory affairs, exactly? Regulatory affairs within the healthcare industry is a profession developed to ensure that companies comply with the current regulations and laws to make safe and efficacious medicinal products available to the public. With the complex regulatory environment of today, this is easier said than done and the path towards a marketing authorization is associated with many challenges.

Build your regulatory roadmap early

To build your regulatory road map, ask questions like: How should the pre-clinical and clinical development programs be designed? What is the legal basis for market authorization? Does the product come with a device? Is your product an orphan drug or would it be eligible for any of the expedited regulatory pathways for approval? Define your disease indication well, and do not forget to include children and adolescents in your plan.


It is crucial to determine when an authority interaction is appropriate to guide your development program forward and to build a relationship with the authority. Most development program comes with budget constraints, and a desire to move fast. Some regulatory risks will and should be taken. Understanding the potential hurdles will help you to make informed decisions, build your rationale and justify your approach. After all, you are the experts on your product. Let’s think about it this way: If your product fails it should be for scientific reasons and not because of a poorly designed program where regulatory opportunities and risks have not been properly addressed and managed.

Stay up to date with the current guidelines

If you think regulatory affairs is a static area of expertise you are mistaken. The regulatory affairs field has evolved over decades and continues to do so. Many improvements in the legislation have occurred as a result of incidents such as the thalidomide disaster in the 1950s when thousands of children suffered from severe birth defects. Changes have also occurred to meet the demand for faster approval of drugs targeting indications where there is an unmet medical need. The complexity of therapeutic products in development increases and biological molecules including a variety of Advanced Therapy Medicinal Products (ATMPs) require special expertise and assessments. Last but not the least, there is a strong commercial interest for generics and biosimilars to be approved according to defined pathways.

Staying up to date with the current legislations and guidelines is challenging and regulatory affairs professionals today spend a lot of time tracking the current requirements. Understanding the legal and scientific constraints and at the same time utilizing the regulatory opportunities for the product of interest is key for regulatory and business success.

Have a global regulatory affairs mindset

Most development programs are designed primarily according to the EU and US regulatory environment. However, the commercial interest also for other countries and regions increases. Particularly Japan and China, but also Russia and countries in the Middle East and Latin America.


Understanding the regulatory environment and landscape in these markets is a huge challenge. You need to build your pre-clinical and clinical programs to meet the requirements in terms of potential ethnicity and data standard considerations. And the manufacturing and quality control strategy needs for example to cover the applicable climate zones. The maturity of the legislation in different countries globally varies and the regulatory processes are often lengthy, unclear, or unpredictable. As a regulatory affairs professional you need to understand what the authority is looking for during review and why. Do they lean on other marketing approvals within their assessment, are there specific regional guidelines to which you need to adhere, should you really expect a scientific discussion or more of a tick-box exercise? If you take these aspects into consideration, your geographic expansion plan has a high probability for successful.



Erika Spens

Director of Regulatory Affairs

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