How Design Systems enable streamlined regulatory approval in digital pharma

Strict and evolving compliance requirements from regulatory bodies often lead to extended review cycles and repetitive revisions.

Each new digital product development or update requires validation against regulatory standards across visual layout, language, disclaimers, accessibility, and risk management considerations—making regulatory submissions complex and time-consuming.

Why is digital pharma so heavily regulated?

Digital pharma is heavily regulated due to the potential risk involved in promoting pharmaceutical and medical device products, impacting patient safety and clinical trial integrity. Regulatory requirements ensure accuracy, clarity, and fairness in all promotional activities, safeguarding public health and managing risks throughout the product lifecycle.

A design system is a centralised library of pre-approved, reusable components and design rules, ensuring regulatory compliance, consistency, and efficiency throughout the design and development process.

These components typically include:

• UI patterns (buttons, forms, layouts)
  
  

• Typography, colour, and spacing standards
  
  

• Accessibility and regulatory guidelines
  
  

• Usage documentation and governance rules
  

Design systems are crucial for streamlining the pharmaceutical development process, providing key advantages in ensuring regulatory compliance.

By offering consistent, reusable building blocks, design systems enable pharma teams to enforce standardised design guidelines and best practices across platforms. This standardisation means that during regulatory submissions, the structure and components are already familiar to regulatory colleagues. Consequently, the review process becomes faster and more predictable, allowing reviewers to concentrate on specific requirements such as content accuracy and wording, rather than layouts or component placements.

Another significant advantage is the design system’s ability to rapidly adapt to changing regulatory requirements. For instance, if new guidance from regulatory authorities mandates a larger disclaimer area or revised risk analyses, teams can quickly update the relevant component in the central design system. This change can then be deployed instantly across all digital properties using that component, eliminating the need for full redesigns and significantly reducing the time and effort required.

Furthermore, design systems enhance consistency in user experiences for healthcare professionals (HCPs) and patients. Familiar navigation and interface structures make digital platforms more user-friendly while maintaining robust regulatory compliance.

Embedding compliance early and continuously throughout the pharmaceutical development lifecycle is crucial for reducing delays and ensuring smooth regulatory submissions. By integrating regulatory considerations into every phase of the design and development process, pharma companies can proactively address compliance issues, anticipate regulatory changes, and minimise risks. Design systems are instrumental in this integration, enabling rapid updates and consistent adherence to evolving regulatory requirements.

Can design systems respond quickly to changing regulations?

Yes, design systems can swiftly respond to evolving regulations. Components are centrally updated, ensuring new compliance requirements are immediately rolled out across all digital products.

For example, if a new regulatory requirement mandates a more prominent disclaimer:

• Only the "disclaimer component" in the design system is updated.
• All pages utilising that component automatically reflect this update.
• There is no need for manual redesigns of every instance.

Through this proactive approach, pharma organisations can efficiently ensure regulatory compliance, significantly reduce the risks associated with regulatory submissions, and improve overall efficiency within their design and development processes.

1. What is involved in the validation process of digital pharma products?
Validation involves ensuring that digital pharma products consistently meet regulatory requirements, standards for accessibility, accuracy of content, technical reliability, and effective risk management throughout the product lifecycle.

2. How can pharma companies integrate risk management into their digital development processes?
Companies should embed risk analyses into their product development cycles, continuously identifying, evaluating, and mitigating potential risks associated with regulatory non-compliance, user experience, or technical functionality.

3. What are the common pitfalls when designing digital pharma content for regulatory submission?
Common pitfalls include inconsistent visual layouts, unclear or non-compliant language, inadequate accessibility standards, incomplete disclaimers, and ineffective integration of regulatory updates into ongoing digital products.

4. Do design systems limit creativity and innovation in digital pharma development?
No. While design systems enforce consistency and compliance, they also allow design teams more room to focus on creative problem-solving and content quality, rather than repeatedly addressing regulatory or layout issues.

5. How do design systems support accessibility compliance in digital pharma platforms?
Design systems include predefined components and clear guidelines aligned with accessibility standards, ensuring platforms are usable by diverse audiences, including users with disabilities, thus supporting regulatory requirements related to accessibility.

6. What happens if a pharma company's digital content does not comply with regulatory standards?
Non-compliance may lead to regulatory delays, rejection of regulatory submissions, penalties, or potential damage to the company's reputation and trust with healthcare professionals (HCPs) and patients.

7. How do regulatory requirements differ for digital pharma content across international markets?
Regulatory requirements can vary significantly across international markets, reflecting local laws, guidelines from regional regulatory authorities, and cultural considerations—highlighting the importance of a flexible yet compliant design system.