Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments

“Guidelines for Drug Information on Pharmaceuticals for Human Use

This document outlines the requirements for drug information related to pharmaceuticals for human consumption, including radiopharmaceuticals, herbal medicines, and complementary medicines. Its goal is to ensure transparency for applicants about the requirements needed for efficient processing. Key aspects covered in the guidelines include:

• Application and Admission: Requirements for application submissions and necessary declarations.
• Declaration of GMOs: Guidelines for disclosing genetically modified organisms in pharmaceuticals.
• Drug Information Adjustments: Updates and changes to drug information requirements, including publication dates.
• Technical Information: Detailed instructions on providing technical data and package leaflets.
• Medicines Under Additional Monitoring: Specific requirements for products under increased monitoring.
• Active Substances and Pharmaceutical Additives: Clear guidelines for declaring active ingredients and additives in medicinal products.
• Swissmedic Submissions: Requirements for transmitting text submissions to Swissmedic for approval.
• Transitional Provisions: Information on transitional arrangements for certain products.
• Packaging and Labeling: Detailed instructions for product labeling, container materials, and packaging information.
• Product Information: Comprehensive details on product information requirements for medicinal products.
• Patient Information: Requirements for patient-facing information to ensure safety and proper use.

Additionally, the document includes guidelines for safety report submission and management, particularly for medicines under the United Kingdom’s Early Access to Medicines Scheme (EAMS), ensuring the safety and monitoring of medicines provided to patients on an expedited basis.

These updates aim to streamline the regulatory process, ensuring that all pharmaceutical products meet safety, quality, and transparency standards.”
region: United States of America
Source: https://www.federalregister.gov/documents/2024/11/14/2024-26399/patient-focused-drug-development-workshop-to-discuss-methodologic-and-other-challenges-related-to