Digital security has always been a key element of technological progress, but today it takes on an entirely new dimension. We live in an era of growing awareness of cyber threats, ongoing hybrid warfare in Europe, and regulations struggling to keep up with the rapid pace of technological innovation. Against this backdrop, the EU’s Cyber Resilience Act (CRA) emerges as a crucial point of reference. By 2027, every digital solution – including those in the pharmaceutical sector – will be required to comply with its standards, while from September 2026, organizations will be obligated to report security incidents within just 24 hours.
For pharmaceutical companies that work daily with patient data, conduct clinical trials, and manage complex supply chains, this is far more than a mere formality. It is a call to thoroughly reassess their IT and OT processes and implement the highest cybersecurity standards. Otherwise, they risk not only severe financial penalties but, more importantly, the safety of patients, their reputation, and position in the global market.
1. Why is the pharmaceutical sector particularly vulnerable?
Modern pharmaceuticals form a complex network of interconnections – from clinical research and genetic data analysis to vaccine logistics and the distribution of life-saving therapies. Each element of this ecosystem has its own unique exposure to cyber threats:
Clinical trials – They collect vast volumes of patient data and regulatory documentation. This makes them a highly attractive target, as such information holds significant commercial value and can be exploited for blackmail or intellectual property theft.
Manufacturing and control systems – OT infrastructure and Manufacturing Execution Systems (MES) were often designed in an era when cybersecurity was not a priority. As a result, many still rely on outdated technologies that are difficult to update, leaving them vulnerable to attacks.
Supply chains – The global nature of active pharmaceutical ingredient (API) and finished drug supply involves cooperation with numerous partners, including smaller companies. It takes only one weak link to expose the entire chain to disruptions, delays, or ransomware attacks.
Regulatory affairs – Documentation required by GMP, FDA, and EMA standards must maintain full data integrity and consistency. Even a seemingly minor incident may be perceived by regulators as a threat to the quality and safety of therapies, potentially halting the release of a drug to market.
2. Real Incidents – A Warning for the Industry
Cyberattacks in the pharmaceutical sector are not a hypothetical threat but real events that have repeatedly disrupted the operations of global companies. Their consequences have gone far beyond financial losses – they have affected drug production, vaccine research, and public trust in health institutions.
In 2017, the NotPetya ransomware caused massive disruptions at Merck, one of the largest pharmaceutical companies in the world. The financial impact was devastating – losses were estimated at around $870 million. The attack crippled production systems, drug distribution, packaging, marketing, and other core business operations.
The lesson for the pharmaceutical sector
The destruction or shutdown of production systems disrupts not only sales but also patient access to essential medicines.
The costs of recovery, logistical disruptions, and lost revenue can far exceed the initial investment in cybersecurity – with long-term consequences.
In 2020, the Indian company Dr. Reddy’s Laboratories fell victim to a ransomware attack. In response, the company isolated affected IT services and shut down data centers, severely disrupting operations. Production was temporarily halted – a particularly serious issue as the company was preparing to conduct clinical trials for a COVID-19 vaccine at that time.
Lessons for the Pharmaceutical Sector
Production downtime directly translates into delays in drug and ingredient availability.
An attack occurring when a company is involved in pandemic-related processes amplifies the level of risk — not only to public health but also to public trust.
One of the most significant incidents that demonstrated how cyberattacks can affect not only business but also social stability was the leak of COVID-19 vaccine data. This attack revealed that in times of a global health crisis, not only the IT systems of pharmaceutical companies are at risk but also society’s trust in science and public institutions.
At the turn of 2020 and 2021, the European Medicines Agency (EMA) confirmed that certain documents related to mRNA vaccines had been unlawfully accessed by hackers. The stolen data included regulatory submissions, evaluations, and documentation, some of which appeared on dark web forums. EMA emphasized that the systems of BioNTech and Pfizer were not compromised and that no clinical trial participant data had been leaked.
Lesson for the pharmaceutical industry
The loss of regulatory documentation undermines trust among both companies and supervisory bodies, potentially delaying or complicating the drug approval process.
The risk extends beyond financial losses to include reputational damage and potential exposure of personal data from clinical trials.
2.1 Key Takeaways
The cases of Dr. Reddy’s, Merck, and EMA show that cyberattacks in the pharmaceutical industry are not a distant threat but a real and present danger capable of paralyzing the entire sector. They strike at every level – from clinical research to production lines and global drug distribution.
The consequences go far beyond financial losses. Delayed therapy deliveries, threats to public health, and loss of regulator and public trust can be far more damaging than material losses alone.
Because of its strategic role during health crises, the pharmaceutical industry is an increasingly attractive target. The motives of attackers vary – from sabotage and industrial espionage to simple extortion – but the outcome is always the same: undermining one of the most critical sectors for societal security.
3. Cyber Resilience Act – What Does It Mean for Pharma, and How Can TTMS Help?
The new Cyber Resilience Act (CRA) imposes obligations on software manufacturers and suppliers, including SBOMs, secure-by-design principles, vulnerability management, incident reporting, and EU conformity declarations.
For the pharmaceutical sector – where patient data protection and compliance with GMP/FDA/EMA standards are critical – implementing CRA requirements is a strategic challenge.
3.1 Mandatory SBOMs (Software Bill of Materials)
CRA requires every application and system to maintain a complete list of components, libraries, and dependencies. The reason is simple: the software supply chain has become one of the main attack vectors.
In pharmaceuticals, where systems manage patient data, clinical trials, and drug manufacturing, a lack of transparency in components could lead to the inclusion of vulnerable or malicious libraries.
An SBOM ensures transparency and enables rapid response when vulnerabilities are discovered in commonly used open-source components.
How TTMS helps:
- Implementing tools for automated SBOM generation (SPDX, CycloneDX)
- Integrating SBOMs with CI/CD pipelines
- Assessing risks associated with open-source components in pharmaceutical systems
3.2 Secure-by-Design Development
The regulation mandates that software must be designed with security in mind from the very beginning – from architecture to implementation.
Why is this so important in pharma? Because design flaws in R&D or production systems can lead not only to cyberattacks but also to interruptions in critical processes such as drug manufacturing or clinical trials.
Secure-by-design minimizes the risk that pharmaceutical systems become easy targets once deployed and difficult to fix.
How TTMS helps:
- Conducting threat modeling workshops for R&D and production systems
- Implementing DevSecOps in GxP-compliant environments
- Performing architecture audits and penetration testing
3.3 Vulnerability Management
CRA goes beyond simply stating that “patches must be applied.” It requires companies to have formal processes for monitoring and responding to vulnerabilities.
In pharmaceuticals, this is vital because any downtime or vulnerability in MES, ERP, or SCADA systems may threaten product batch integrity and, ultimately, drug quality. The regulation aims to ensure vulnerabilities are detected and mitigated before they escalate into patient safety incidents.
How TTMS helps:
- Building SAST/DAST processes tailored to pharmaceutical environments
- Monitoring vulnerabilities in real time
- Developing procedures aligned with CVSS and regulatory requirements
3.4 Incident Reporting
CRA mandates that security incidents must be reported within 24 hours.
This requirement aims to prevent a domino effect across the EU – enabling regulators to assess risks for other organizations and sectors.
In the pharmaceutical context, delayed reporting could endanger patients by disrupting drug supply chains or delaying clinical trials.
How TTMS helps:
- Creating Incident Response Plans (IRP) customized for the pharma sector
- Implementing detection systems and automated reporting workflows
- Training IT/OT teams in CRA-compliant procedures
3.5 Declaration of Conformity with EMA and CRA Regulations
Each manufacturer will be required to issue a formal declaration of conformity with CRA and label their products with the CE mark.
This introduces legal accountability – pharmaceutical companies can no longer rely on declarative assurances but must demonstrate compliance of both IT and OT systems.
For the industry, this means aligning CRA requirements with existing GMP, FDA, and EMA standards, ensuring that digital security becomes an integral part of product quality and lifecycle compliance.
How TTMS helps:
- Preparing full regulatory documentation
- Supporting clients during audits and inspections
- Aligning CRA requirements with GMP and ISO standards
4. Why Partner with TTMS?
- Proven experience in pharma – supporting clients in R&D, manufacturing, and compliance; familiar with EMA, FDA, and GxP requirements.
- Quality & Cybersecurity experts – operating at the intersection of IT, OT, and pharmaceutical regulations.
- Ready-to-use solutions – SBOM, incident management, and automated testing.
- Flexible cooperation models – from consultancy to Security-as-a-Service.
5. Ignoring CRA Could Cost More Than You Think
Non-compliance with the CRA is not just a formality – it represents a critical operational risk for pharmaceutical companies.
Penalties can reach €15 million or 2.5% of global annual turnover, and in severe cases, result in exclusion from the EU market.
However, financial penalties are only the beginning. Unprepared organizations expose themselves to incidents that can disrupt clinical trials, paralyze production, and endanger patient safety.
In a sector where reputation and regulatory trust directly determine the ability to operate, these risks are hard to overestimate.
Experience shows that the costs of real attacks, such as ransomware, often far exceed the investment in proactive compliance and security.
In other words, failing to act today may lead to a bill tomorrow that no company can afford to pay.
6. When Should You Take Action?
6.1 RA Implementation Timeline for the Pharmaceutical Sector
September 11, 2026 – From this date, all companies placing digital products on the EU market (including pharmaceutical systems covered by CRA) must report security incidents within 24 hours of detection and disclose actively exploited vulnerabilities.
This means that pharmaceutical organizations must have:
- Established incident response procedures (IRP),
- Trained teams capable of timely reporting, and
- Tools that enable threat detection and automation of the reporting process.
December 11, 2027 – From this moment, full compliance with the CRA becomes mandatory, covering all regulatory requirements, including:
- Implementation of secure-by-design and secure-by-default principles,
- Maintaining SBOMs for all products,
- Active vulnerability management processes,
- A formal EU Declaration of Conformity and CE marking for digital products,
- Readiness for audits and inspections by regulatory authorities.
TTMS supports organizations throughout the entire compliance journey – from initial audit and implementation to training and documentation. This ensures that pharmaceutical companies maintain continuity in research, manufacturing, and distribution while meeting legal and regulatory expectations.
Visit our page Pharma Software Development Services to explore the digital solutions we provide for the pharmaceutical industry.
Also, check our dedicated cybersecurity services page for tailored protection and compliance support.
When will the Cyber Resilience Act start applying to the pharmaceutical sector?
The CRA was adopted in October 2024. Full compliance will be required from December 2027, but the obligation to report incidents within 24 hours will already apply from September 2026. This means companies must quickly prepare their systems, teams, and procedures.
Which systems in the pharmaceutical sector are covered by the CRA
The CRA applies to all products with digital elements – from applications supporting clinical trials and MES or LIMS systems to platforms managing patient data. In practice, almost every digital component of a pharmaceutical infrastructure will need to meet the new requirements.
What obligations does the CRA impose on pharmaceutical companies?
Key obligations include: creating SBOMs, adopting secure-by-design principles, managing vulnerabilities, reporting incidents, and preparing an EU Declaration of Conformity. These are not mere formalities – they directly impact patient data security and the integrity of production processes.
What are the penalties for non-compliance with the CRA?
Penalties can reach €15 million or 2.5% of global annual turnover, along with potential withdrawal of products from the EU market and a heightened risk of cyberattacks. In the pharmaceutical sector, this may also mean disrupted clinical trials, production downtime, and loss of regulator trust.
Must incidents be reported even if they caused no damage?
Yes. The CRA requires the reporting of any major incident or actively exploited vulnerability within 24 hours. The organization then has 72 hours to submit an interim report and 14 days for a final report. This applies even to situations that did not interrupt production but could have threatened patient safety or data integrity.