NAFDAC Guidelines for Labelling of Investigational Medicinal Products
Guideline · Health
Guidelines specify labelling requirements for investigational medicinal products used in clinical trials. They target pharmaceutical companies and NAFDAC inspectors to include essential details like trial identification and storage instructions. This ensures patient safety through clear and compliant labelling.
NAFDAC Guidelines for Labelling of Investigational Medicinal Products
What Is This Policy?
Guidelines specifying the labelling requirements for medicines used in clinical trials, ensuring proper identification, traceability, and blinding where required.
Who Does It Target?
Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders
What Does It Aim to Achieve?
Ensure patient safety in clinical trials through clear, compliant labelling of investigational products.
Key Features
Essential Information: Trial identification number, product code, dosage form, and route of administration Blinding Requirements: Labelling that maintains the integrity of blinded trials Storage Instructions: Temperature and handling requirements on the label Sponsor Contact: Emergency contact information for the trial sponsor
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply with these guidelines. Prepare labels per NAFDAC requirements Submit label samples with trial application Maintain labelling records throughout the trial
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the National Code for Health Research Ethics 2007, the ICH E6 Good Clinical Practice Guidelines, the WHO Guidance on Clinical Trials, and the Nuremberg Code principles as adopted in Nigerian health research policy.