This article outlines how the EMA and ABPI compare, where they overlap, how they differ, and what best practices should guide pharmaceutical companies when reviewing promotional material under their respective systems.
What is the EMA?
The European Medicines Agency is a decentralised body of the European Union that is responsible for evaluating and supervising medicines for human and veterinary use across EU member states and European Economic Area (EEA) countries.
- Centralised marketing authorisations for the EU/EEA (excluding the UK post-Brexit)
- Scientific advice to support drug development
- Pharmacovigilance and risk management oversight
- Coordination of inspections and good clinical/manufacturing practices
The EMA's primary concern is the scientific quality, safety, and efficacy of medicinal products. While it does not pre-approve promotional content, it exercises substantial influence over promotional activities through its approved product information, particularly the Summary of Product Characteristics (SmPC), which serves as the authoritative source for all promotional claims.
What is the ABPI?
The Association of the British Pharmaceutical Industry is the UK trade body for innovative pharmaceutical companies. It sets ethical and operational standards for the promotion of prescription medicines through its Code of Practice.
- Publishes and maintains the ABPI Code of Practice, enforced by the Prescription Medicines Code of Practice Authority (PMCPA)
- Represents the industry in health policy and market access discussions
- Supports industry training, education, and cross-sector collaboration
- Operates Disclosure UK for transparency reporting
Unlike the EMA, the ABPI does not authorise medicines or evaluate safety data. Its focus is on ethical marketing practices and maintaining trust between pharmaceutical companies and healthcare professionals. While technically voluntary, the ABPI Code has quasi-regulatory status in the UK pharmaceutical industry, with most companies required to comply as a condition of ABPI membership.
Areas of overlap
Although their mandates differ, the EMA and ABPI interact in several meaningful ways:
Product information integrity
Promotional claims must align with the product's Summary of Product Characteristics (SmPC), which is approved as part of the EMA marketing authorisation process. The ABPI Code explicitly requires that promotional material does not exceed the scope or contradict the SmPC, creating a direct link between regulatory approval and promotional compliance.
Post-marketing updates
The EMA may require changes to labelling, contraindications, or warnings based on new safety data. The ABPI Code demands prompt and accurate communication of such updates to healthcare professionals through both non-promotional and promotional channels, typically within 48-72 hours of notification.
Reference data and substantiation
EMA-approved data form the primary evidence base for promotional claims. The ABPI Code requires that claims be balanced, factual, and capable of substantiation, making EMA-reviewed documents the natural foundation for promotional review and certification.
Key differences
| Area | EMA | ABPI |
|---|---|---|
| Role | Regulatory agency | Trade association with quasi-regulatory function |
| Legal Authority | Binding EU-level decisions | Industry code with significant commercial consequences |
| Scope | Safety, efficacy, market authorisation | Ethical promotion, industry standards, transparency |
| Promotional Material Oversight | Indirect but substantial via SmPC and product licence | Direct via Code of Practice and certification |
| Enforcement | Regulatory sanctions, market withdrawal | PMCPA rulings, public sanctions, reputational damage |
| Jurisdiction | EU/EEA (excluding UK post-2021) | United Kingdom |
| Appeal Process | Administrative review and EU courts | PMCPA Appeal Board |
| Timeline | Months to years for major decisions | Days to weeks for promotional review |
Best practices for promotional material review under EMA requirements
While the EMA does not approve promotional material, compliance with its outputs is essential. Promotional content must be scientifically accurate, non-misleading, and consistent with the SmPC.
- Use the approved SmPC as the authoritative baseline: Avoid extrapolating beyond authorised claims or suggesting broader efficacy than demonstrated
- Establish proactive regulatory monitoring: Implement systems to track regulatory updates and post-marketing commitments within 24-48 hours of publication
- Maintain strict off-label boundaries: Do not imply unapproved uses through selective data presentation, audience targeting, or contextual suggestion
- Ensure balanced risk-benefit presentation: Include appropriate safety information proportional to efficacy claims
- Engage regulatory affairs early and continuously: Involve regulatory experts from content conception through final approval, not just sign-off
- Document regulatory rationale: Maintain clear records linking promotional claims to specific SmPC sections and supporting data
- Plan for post-authorisation changes: Build flexibility into promotional strategies to accommodate potential label updates
Best practices for promotional review under the ABPI code
Promotional material in the UK must adhere to the ABPI Code of Practice. The PMCPA can investigate complaints and issue public sanctions that significantly impact company reputation and market access.
- Implement rigorous internal review processes: Require sign-off from medical, legal, and regulatory reviewers with documented ABPI Code training
- Ensure claims are balanced and substantiated: Use peer-reviewed publications, regulatory assessments, and avoid cherry-picking favorable data
- Use clear, unambiguous language: Avoid exaggeration, unqualified comparisons, and ensure claims are immediately understandable to the target audience
- Maintain strict separation of promotional and educational content: Clearly distinguish marketing materials from medical education, with different approval processes
- Comply with Disclosure UK requirements: Report all transfers of value to healthcare professionals within specified timeframes
- Establish comprehensive documentation: Maintain detailed records of development, review, approval, and distribution decisions
- Provide regular, role-specific training: Ensure commercial, medical, and regulatory teams receive updated ABPI Code training at least annually
- Address digital and social media considerations: Apply Code principles to online activities, including third-party content and interactive platforms
- Implement adverse event reporting procedures: Ensure promotional activities don't interfere with pharmacovigilance obligations
Post-Brexit environment: navigating dual regulatory pathways
The UK's departure from the EU on January 31, 2020, with the transition period ending December 31, 2020, fundamentally changed the regulatory landscape:
- UK: MHRA serves as the independent regulatory body, with the ABPI Code remaining the standard for promotional practices
- EU/EEA: EMA continues to regulate medicine authorisation for the remaining 27 EU member states plus EEA countries
- Dual compliance requirement: Companies seeking both UK and EU market access must navigate parallel but distinct regulatory processes
Practical implications: Separate marketing authorisation applications may be required for UK (MHRA) and EU (EMA) markets. Promotional materials may need different versions to reflect jurisdiction-specific approved product information. Post-marketing safety updates may have different timing and content requirements. Companies must maintain expertise in both regulatory systems while ensuring consistent global messaging.
International context and global considerations
For multinational pharmaceutical companies, EMA and ABPI frameworks must be considered alongside other regulatory requirements:
- FDA coordination: Align promotional strategies across EU, UK, and US markets while respecting jurisdictional differences
- ICH guidelines: Leverage international harmonisation where possible for efficiency
- Global safety reporting: Ensure promotional activities support rather than complicate worldwide pharmacovigilance obligations
Digital age considerations
Modern promotional activities increasingly involve digital channels that present unique compliance challenges:
- Social media governance: Apply traditional promotional principles to dynamic online environments
- Third-party content: Maintain responsibility for promotional content shared or endorsed by others
- Data privacy: Ensure promotional activities comply with GDPR and UK data protection requirements
- Measurement and monitoring: Implement systems to track and evaluate digital promotional effectiveness while maintaining compliance