Draft Guideline: Standardized Management and Writing of Vaccine Instructions

“This guideline provides technical instructions for drafting vaccine information to ensure safe and effective use. Key points include:

1. Public Comment Deadline: Feedback is open until 26-Sep-2024. A feedback form is provided for revisions, including name, contact information, and proposed content changes.
2. Drafting Process:

• Developed by the Clinical Department of Biologics, part of the 2024 Guiding Principles Revision Plan.
• It builds on the 2006 guidelines for chemical drugs and biological products.

1. Responsibility:

• The Marketing Authorization Holder (MAH) is responsible for drafting and revising instructions, ensuring accuracy and compliance throughout the product’s life cycle.

1. Life Cycle Management:

• Instructions should include data from pre- and post-marketing studies.

1. Basic Principles:

• Labels must present safety (clinical trial and post-marketing data) and efficacy (protective efficacy and immunogenicity) information.

1. Writing Requirements:

• Instructions must cover warnings, eligibility, dosage, adverse reactions, contraindications, precautions, drug interactions, and considerations for special populations.

1. Special Populations:

• Include recommendations for pregnant women, breastfeeding mothers, and infants, advising doctor consultation if data is lacking.

1. Clinical Trials:

• Include objective trial details such as design, demographics, efficacy indicators, and results. Separate analyses for different populations may be necessary.

1. References:

• Guidance from regulatory bodies like the National Drug Administration, FDA, and EMA is referenced to ensure accuracy in labeling.

These guidelines ensure that vaccine instructions are clear, accurate, and provide vital safety and efficacy information for users.”

Source:https://www.cde.org.cn/main/news/viewInfoCommon/7d1297bac5518691d7bdb00e49dad73a##~https://www.cde.org.cn/main/att/download/4219c9cea2003bf96075ed12b574cda2##~https://www.cde.org.cn/main/att/download/ab58f555ea380970107933e516fdc7c1##~https://www.cde.org.cn/main/att/download/e6d205212a19da83cb38e1ffa13e0969

Region: China