The challenges of regulatory compliance in the pharmaceutical sector
- Dr. Baptiste Alcamer
- Nov 30, 2025
- 6 min read
Regulatory compliance in the pharmaceutical industry is much more than a legal obligation: it is a strategic, ethical, and operational imperative that guarantees patient safety, product quality, and access to global markets. In a constantly evolving regulatory landscape, marked by ever-stricter requirements and enhanced controls, compliance becomes a driver of competitiveness and trust.
“Compliance is not a constraint, but a strategic investment that protects patients and strengthens the reputation of companies,” emphasizes Dr. Sylvie Bernard , former official at the EMA and consultant in pharmaceutical regulation.
This article explores the regulatory frameworks, risks of non-compliance, key requirements and best practices that define the current pharmaceutical environment, drawing on concrete examples and authoritative sources.
1. Regulatory frameworks: complexity and global harmonization
Pharmaceutical regulations vary considerably from region to region, but harmonization efforts are underway to ensure the safety and efficacy of medicines globally.
• Europe (EMA and ANSM) : The European Medicines Agency (EMA) and the French National Agency for Medicines and Health Products Safety (ANSM) define strict guidelines covering the entire drug lifecycle, from R&D to pharmacovigilance. Regulation (EU) 536/2014 on clinical trials and Good Pharmacovigilance Practice (GVP) governs post-authorisation surveillance. For example, GVP IV requires proactive risk management for high-risk medicines.
· WHO : The World Health Organization publishes guidelines for emerging countries, such as Good Manufacturing Practices (GMP) and pharmacovigilance standards, to ensure access to safe and effective medicines in resource-limited regions.
• Morocco (DMP) : The Directorate of Medicines and Pharmacy (DMP) in Morocco follows a regulatory framework inspired by the EMA and WHO, with specific requirements for the import, manufacture, and distribution of medicines. Morocco serves as a regular hub for Francophone Africa, with initiatives such as the Reference Price of Medicines to control costs and quality.
• United States (FDA) : The Food and Drug Administration (FDA) imposes strict rules through the Code of Federal Regulations (21 CFR) , including GMP and pharmacovigilance requirements. Companies must submit periodic reports (PADERs) and implement risk mitigation strategies (REMS) for high-risk products.
"Harmonizing regulations is essential to facilitating access to medicines in emerging countries, but it requires increased international collaboration," notes Prof. Alioune Diop , coordinator of the Africa Medicines Agency (AMA).
2. Risks associated with non-compliance: serious and multifaceted consequences
Non-compliance with pharmaceutical regulations leads to severe financial, legal and reputational consequences, which can compromise the very viability of companies.
• Fines and financial penalties : Violations of GMP or pharmacovigilance regulations can result in enormous fines. For example, Novartis was fined $400 million in 2020 for bribery in the United States, while Pfizer paid $2.3 billion in 2009 for improper promotion of its products. In Europe, the ANSM (French National Agency for Medicines and Health Products Safety) can impose fines of up to 5% of annual turnover for non-compliance with pharmacovigilance requirements.
• Product recalls and suspensions : Non-compliance can lead to the immediate withdrawal of products from the market. In 2023, Emergent Biosolutions had to destroy 400 million doses of COVID-19 vaccines due to GMP non-compliance, resulting in financial losses and a major crisis of confidence.
• Damage to reputation and loss of trust : Regulatory scandals erode the trust of patients, investors, and partners. "A single violation can wipe out decades of trust," warns Michel Petit , quality director at Sanofi.
• Risks to patients : Non-compliance can directly threaten public health, as in the case of the diabetes drug Avandia (GSK), withdrawn from the market in 2010 due to undisclosed cardiac risks.
Table 1: Examples of sanctions for non-compliance in the pharmaceutical industry
Business | Year | Sanction | Reason |
Novartis | 2020 | $400 million (fine) | Corruption and illegal business practices |
Pfizer | 2009 | $2.3 billion (fine) | Non-compliant promotion of medications |
Emergent Biosolutions | 2023 | Destruction of 400 million doses of vaccines | Non-compliance with GMP |
GSK | 2010 | Product recall (Avandia) | Concealing cardiac risks |
3. Key requirements: GMP and pharmacovigilance
Good Manufacturing Practices (GMP) and pharmacovigilance are the pillars of regulatory compliance, ensuring product quality and safety at all stages of their life cycle.
• Good Manufacturing Practices (GMP) : GMPs govern the production of medicines to guarantee their quality, purity, and stability. They include:
o Validation of production and cleaning processes.
o Quality control of raw materials and finished products.
o Complete traceability via robust documentation systems.
o Ongoing staff training. Example : Roche implemented a blockchain system to ensure the traceability of its supply chain, thereby strengthening compliance with GMP.
Pharmacovigilance : Ongoing monitoring of adverse drug reactions after marketing is crucial. Requirements include:
o The collection and analysis of adverse event reports (ICSRs) within the allotted time (15 days for serious cases in the EU and the United States).
o Submission of periodic reports (PBRER in the EU, PADER in the United States).
o The implementation of risk management plans (RMP in the EU, REMS in the United States). Example : Sanofi uses AI to detect early risk signals in its pharmacovigilance databases.
“Pharmacovigilance is a moral and regulatory duty that never ends. Ignoring a weak signal can have catastrophic consequences,” recalls Dr. Margaret Chan , former Director-General of the WHO.
4. Examples of good practices: from global leaders to international initiatives
Several global players and international initiatives illustrate how to integrate compliance into a robust industrial strategy.
Big Pharma : Pharmaceutical giants like Novartis , Roche , and Sanofi have dedicated compliance departments equipped with sophisticated quality management systems (QMS). For example:
Novartis has implemented a compliance program that includes quarterly internal audits and mandatory training for all employees.
Roche uses AI tools to monitor the compliance of its factories with GMP in real time.
Gavi and The Global Fund : These international organizations link their funding to strict adherence to quality standards. For example:
Gavi requires recipient countries to comply with WHO standards for vaccines and report quality data via the Price and Quality Reporting (PQR) mechanism.
The Global Fund makes its funding conditional on adherence to Good Distribution Practices (GDP) and pharmacovigilance, with regular audits by Local Fund Agents (LFAs) . Case study : In the Democratic Republic of Congo , the program supported by Gavi and The Global Fund strengthened the cold chain for vaccines through the strict application of GDP and pharmacovigilance protocols.
• African initiatives : The Africa Medicines Agency (AMA) is working to harmonize regulations across the continent, drawing inspiration from the models of the EMA and the WHO. Countries like Morocco and Ghana serve as models for implementing robust quality systems.
Case study : In Morocco , the DMP implemented an accelerated marketing authorization (MA) system for essential medicines, while ensuring compliance with GMP through annual inspections of production sites.
Table 2: Good compliance practices in the pharmaceutical industry
Actor | Initiative | Impact |
Novartis | Integrated Compliance Program | Reduction of fines and product withdrawals |
Rock | Blockchain for traceability | Transparency and compliance with GMP |
Gavi | PQR Mechanism | Quality control of vaccines in beneficiary countries |
The Global Fund | Audits by LFAs | Ensuring compliance in transition countries |
DMP Morocco | Annual inspections and accelerated marketing authorization | Improved access to essential medicines |
Conclusion
Regulatory compliance is more than just a requirement; it is a fundamental pillar of trust, innovation, and market access in the pharmaceutical industry. Companies that invest in robust compliance systems—integrating GMP, pharmacovigilance, and a culture of quality—not only avoid severe penalties but also gain a sustainable competitive advantage.
"In a world where regulations are evolving rapidly, compliance is becoming an engine of growth and social responsibility," summarizes Dr. Jean-Jacques Muyembe , co-discoverer of the Ebola virus and promoter of local vaccine production in the DRC.
For pharmaceutical companies, whether multinationals or local SMEs, the future belongs to those who make compliance the heart of their strategy.
For your support needs – whether it is the drafting of an application for authorization to practice, the implementation of a quality management system (QMS) or the audit of your pharmaceutical website – Nabati Advisory provides you with a dedicated team and a proven methodology to guide you at every stage.
Sources and References
1. EMA : Good Pharmacovigilance Practices (GVP) , 2024.
2. ANSM : GMP Reference - 2024 Edition .
3. WHO : WHO Guidelines on Pharmaceutical Regulations , 2023.
4. FDA : Code of Federal Regulations (21 CFR) , 2024.
5. Gavi : Market Shaping and Quality Assurance Report , 2023.
6. The Global Fund : Quality Assurance Policy Framework , 2024.
7. VComply : Pharmaceutical Compliance Best Practices , 2024.
8. Proventa International : Regulatory Compliance in the Pharma Industry , 2023.
9. UNDP : Compliance with the Global Fund Requirements , 2023.
10. BMGF : Strengthening Regulatory Systems in Africa , 2023.
To learn more about our regulatory compliance support services, contact Nabati Advisory at [ contact@nabati-advisory.com ].
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