深度报告-2026-04-30-世界卫生组织-Instructions_for_applicants_preparing_a_submission_for_the_2027_meeting_of_the_WHO_Expert_Committee_on_Selection_and_Use_of_Essential_Medicines_34页_496kb

2027 WHO Essential Medicines Submission Instructions Summary

Core Content

This document outlines the mandatory format and key information requirements for applicants seeking to submit proposals for the inclusion of new medicines or new indications for existing medicines in the WHO Model List of Essential Medicines (EML) and WHO Model List of Essential Medicines for Children (EMLc) during the 26th meeting of the WHO Expert Committee on Selection and Use of Essential Medicines, scheduled for 3–7 May 2027 in Geneva.

Key Requirements for Submissions

• Format and Structure: Submissions must follow a specific structure, including a title page, 12 sections with relevant information and evidence, and a reference list.
• Deadline: Submissions must be sent by Friday, 6 November 2026, 18h00 UTC in both PDF and Word formats to emlsecretariat@who.int.
• Content Sections:
  • Section 1: A concise summary statement (max 500 words) of the proposal, covering clinical indication, target population, and therapeutic role.
  • Section 2: A key information summary table with details such as INN, ATC code, indication, ICD-11 code, pharmaceutical forms and strengths, and list category (EML, EMLc, or both).
  • Section 3: Clarification of whether the medicine is proposed as an individual medicine or as a representative of a pharmacological class/therapeutic group (square box listing), including justification and alternatives.
  • Section 4: Information on consultation with WHO technical departments, including their names, focal points, and dates.
  • Section 5: Details of any other organizations consulted or supporting the submission, including their role and contributions.
  • Section 6: Evidence supporting the public health relevance, including epidemiological data and current alternatives on the Model Lists.
  • Section 7: Treatment details such as dosage regimen, duration of treatment, and requirements for appropriate use.
  • Section 8: Review of evidence for benefits and harms, including comparative effectiveness and safety against current treatments.
  • Section 9: Summary of recommendations in current clinical guidelines.
  • Section 10: Comparative cost and cost-effectiveness data.
  • Section 11: Regulatory status, market availability, and pharmacopoeial standards.
  • Section 12: Reference list.

Important Notes

• INN Usage: All submissions must use International Non-proprietary Names (INN) for medicines, not brand names.
• Transparency: The use of artificial intelligence tools is allowed, but must be fully and transparently disclosed.
• Confidentiality: Submissions will be published on the WHO website and must not include commercially protected information.
• Citations and Permissions: Any material copied from other sources must be properly cited and permission obtained where necessary.
• Funding Disclosure: All submissions must disclose any funding or financial support and include a declaration of interest from the authors.

Disclaimers and Legal Information

• License: The document is available under the CC BY-NC-SA 3.0 IGO license.
• Disclaimer: The use of the WHO logo is not permitted. The designations in the document do not imply any WHO endorsement.
• Third-Party Materials: If third-party content is reused, permission must be obtained and proper attribution provided.
• Liability: WHO disclaims all liability for damages arising from the use of the document.

Contact Information

All inquiries should be directed to:

• The Secretary
• WHO Expert Committee on Selection and Use of Essential Medicines
• Department of Medicines and Health Products Policies and Standards
• World Health Organization, Geneva
• Email: emlsecretariat@who.int

Additional Resources

• CIP Data: Available at https://iris.who.int.
• Book Orders: To purchase WHO publications, visit https://www.who.int/publications/book-orders.
• Copyright Queries: Visit https://www.who.int/copyright.
• Useful Resources:
  • Institute for Health Metrics and Evaluation
  • Global Cancer Observatory
  • WHO Global Health Observatory
  • WHO Model List of Essential Medicines (2025)
  • WHO Model List of Essential Medicines for Children (2025)
  • WHO electronic EML (eEML) database

Summary of Key Sections

Section	Content
1	Summary statement of the proposal (max 500 words)
2	Key information summary table (INN, ATC code, indication, ICD-11 code, forms, strengths, list category)
3	Listing as an individual medicine or square box (representative of a class/group)
4	Consultation with WHO technical departments
5	Other organizations consulted or supporting the submission
6	Public health relevance, including epidemiological data and current alternatives
7	Treatment details (dosage, duration, use requirements)
8	Evidence for benefits and harms, comparative effectiveness and safety
9	Summary of current clinical guidelines
10	Comparative cost and cost-effectiveness data
11	Regulatory status, market availability, and pharmacopoeial standards
12	Reference list

Disclaimers

• The designations and material presentation in the document do not imply any WHO endorsement or legal opinion.
• The mention of specific companies or products does not imply WHO endorsement.
• The names of proprietary products are distinguished by initial capital letters.
• The names of the authors and applicants must be disclosed, including any financial, professional, or personal interests.

Conclusion

The document emphasizes the importance of transparency, adherence to format, and evidence-based submissions for the 2027 WHO Expert Committee meeting. It provides a structured approach to ensure that proposals are comprehensive, compliant, and aligned with WHO strategies and priorities.