Navigating EMA and Global Regulations for Medical Information Services

Medical Information services are essential to ensure healthcare professionals (HCPs), patients, and regulatory bodies receive accurate, timely, and compliant information. From managing inquiries to medical writing and clinical trial support, these services are foundational to patient safety and product success.

At ProPharma, we specialize in guiding clients through the evolving global regulatory landscape to maintain compliance, consistency, and excellence across markets.

Breaking Down Key EMA Regulations

The European Medicines Agency (EMA) is a regulatory body responsible for ensuring a high level of public health protection within the European Union (EU). Key regulations impacting Medical Information services include:

• The General Data Protection Regulation (EU) 2016/679: This regulation establishes rules for protecting personal data, ensuring that patients' privacy is maintained while allowing the free movement of data within the EU.
• Directive 2001/83/EC: This directive covers the summary of product characteristics, labeling and package leaflets for medicinal products. It ensures that patients and HCPs receive accurate and comprehensive information about medicines.
• Commission Implementing Regulation (EU) No 520/2012: This regulation outlines operational aspects related to pharmacovigilance, including the transparent communication of safety information to patients and HCPs.

Together, these regulations ensure that Medical Information services provide reliable and timely information to patients and HCPs.

The Global Regulatory Landscape

Beyond the EU, regulatory frameworks vary widely. ProPharma supports clients in navigating these complexities across key regions:

North America

• United States: The Food and Drug Administration (FDA) regulates truthful and non-misleading drug promotion through the Prescription Drug Marketing Act (PDMA) and the Food, Drug, and Cosmetic Act (FD&C Act). The Office of Prescription Drug Promotion (OPDP) enables open discussions of insurance coverage, unique among global regulators.
• Canada: Agile Licensing for Drugs framework supports timely access to therapies with rolling reviews and flexible approvals.

Europe

• UK: Pharmaceutical Information and Pharmacovigilance Association (PIPA) guidelines require dual review of patient communications for accuracy.
• Italy: Italian Privacy Code, enforced by the Garante (Data Protection Authority), mandates local consent rules that diverge from EU norms, requiring tailored compliance strategies.

Asia-Pacific

• Japan: Pharmaceuticals and Medical Devices Agency (PMDA) requires rigorous documentation for medical information dissemination.
• China: National Medical Products Administration (NMPA) mandates strict guidelines for promoting medical products.
• Australia: Goods Administration (TGA) emphasizes safety and efficacy of therapeutic goods.

Latin America

• Brazil: National Health Surveillance Agency (ANVISA) requires pre-approval for drug advertising.
• Mexico: Federal Commission for the Protection against Sanitary Risk (COFEPRIS) enforces stringent medical information dissemination rules.
• Colombia: National Food and Drug Surveillance Institute (INVIMA) regulates medical devices and health products.

Compliance Without Borders: ProPharma's Global Strategy

Navigating these diverse regulations requires a deep understanding of each country's legal requirements and a commitment to maintaining compliance across all markets. At ProPharma, our team of experts are dedicated to helping our clients achieve and maintain compliance with all relevant regulations. Here's how we do it:

1. Global Presence: Our 24/7/365 international Medical Information service line works collaboratively to ensure that our clients receive consistent, high-quality service across time zones and regulatory environments.
   
   
2. Tailored Solutions: We recognize that each client has unique needs and challenges. That's why we offer customized solutions to meet local requirements, from compliant content development to regulatory training.
   
   
3. Technology-Driven: We leverage AI, regulatory alerts from the EMA and FDA, and text extraction technologies to stay ahead of regulatory changes.
   

   'At ProPharma, we see AI and automation as valuable co-pilots that help our Medical Information specialists work more efficiently while still delivering the human compassion, judgment, and quality our clients rely on. By thoughtfully integrating AI into our processes like triage, content search, and response generation, we're able to respond faster, ensure accuracy, and reach more people around the world with high-quality, compliant information.'

   — Emily Bevington, Associate Director, Global Innovation & Implementation at ProPharma

4. Data Transparency: We transitioned from traditional shared drives to SharePoint to strengthen our compliance efforts. This shift enhances data security, streamlines data management, improves collaboration, and ensures we deliver accurate, reliable, and compliant medical information to our clients.
   
   
5. Ongoing Training: We designed the Inspection Readiness Resource Center (IRRC), a centralized hub with the goal of enhancing organizational readiness for regulatory inspections. The IRRC consolidates essential resources, streamlines processes, equips staff through targeted training, and enables proactive risk management.
   

   'The IRRC demonstrates ProPharma's commitment to quality and compliance.'

   — Brandy DePung, Director, Global Pharmacovigilance Quality at ProPharma

Looking Ahead, Together

At ProPharma, your mission is our mission. As global regulations evolve, we remain focused on what matters most, supporting your success. We're committed to being a trusted partner, helping you navigate the complexities of medical information services with clarity and confidence.

Let's move forward together. Contact us today to learn how ProPharma can support your regulatory compliance needs.

Blog Author

Mackenzie Wadkins

Senior Medical Information Specialist