The European Medicines Agency (EMA) has released a comprehensive document "Scientific guidelines with summary-of-product-characteristics recommendations" consolidating scientific guidelines with Summary of Product Characteristics (SmPC) recommendations. This guidance serves as an essential reference for pharmaceutical companies preparing SmPCs, ensuring consistency and compliance with European Union (EU) regulatory standards.
The (SmPC) is a critical regulatory document that provides detailed information about a medicinal product, including its therapeutic indications, dosages, and potential side effects. It acts as a cornerstone for safe and effective use by healthcare professionals.
The EMA’s guidelines specifically focus on harmonizing SmPC content with scientific evidence and regulatory requirements.
Key Sections of the Guidance is captured in a tables in the guidance and only include adopted scientific guidelines that refer specifically to the SmPC. For complete information on scientific guidelines, please refer to the European Medicines Agency website
1. Clinical Efficacy and Safety
This section covers recommendations for incorporating clinical efficacy and safety data into the SmPC.
Therapeutic Indications: Align therapeutic claims with clinical trial data.
Special Populations: Include dosing information for pediatrics, geriatrics, and patients with renal or hepatic impairments.
Adverse Reactions: Detail clinically significant side effects observed during trials, stratified by frequency.
Interactions and Contraindications: Provide robust information about drug-drug, drug-food, and drug-disease interactions.
2. Quality and Biological Aspects
This section ensures that the quality and biological properties of a medicinal product are well-documented in the SmPC.
Excipients: Provide detailed labeling of excipients, including those with known safety concerns, as outlined in EMA’s General Guidance on Excipients Labeling.
Biological Products: Include stability data, batch-to-batch consistency, and specifications for biosimilars.
3. Non-Clinical Data
Non-clinical recommendations focus on preclinical safety data, including:
Toxicology: Include findings from carcinogenicity, reproductive toxicity, and genotoxicity studies.
Pharmacodynamics and Pharmacokinetics: Summarize non-clinical studies that inform the mechanism of action and drug metabolism.
Environmental Risk Assessment: Address the potential environmental impact of the medicinal product.
Adopted Guidelines
The document includes only those guidelines that have been officially adopted by the EMA. Each scientific guideline directly refers to the SmPC to maintain precision in product information.
Guidelines Under Review
Guidelines currently under review are marked with an asterisk (*). This ensures transparency about updates that may impact regulatory compliance.
General Guidance on Product Information
Additional information on product information requirements, including labeling for excipients, is available through EMA’s centralized resources. This enhances clarity for sponsors and regulatory professionals.
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