2010-02-28-世界卫生组织-Report_of_the_first_meeting_of_the_Paediatric_medicines_Regulators_Network_28页_304kb

报告摘要

Paediatric Medicines Regulators' Network First Meeting Summary

Report published by WHO, Geneva, 15-17 Feb 2010

1. Meeting Objectives

To discuss Network development for regulators focused on pediatric medicines.
To review regulatory/scientific/ethical standards for pediatric medicines and their applicability to developing countries.
To define the Network's role in shaping international pediatric medicine recommendations.

2. Key Discussions

2.1 Common Standards for Registration

Harmonized terminology needed for global dialogue.
Develop guidelines for Pediatric Development Plans (PDP), dossier evaluation, and safe/age-appropriate dosage forms.
Capacity building and training provided.

2.2 Information Sharing Mechanisms

Tools suggested: WHO website, SharePoint, electronic newsletters.
Stakeholders identified: NMRAs, NGOs, industry, CROs, IRBs, regulators.
Topics to share info on: Clinical trials, product specs, regulatory policies, safety, formulation studies.

2.3 Capacity Development Needs

Short-term: Clinical trial protocol review, marketing authorization dossier evaluation, ethics.
Long-term: Electronic submissions, clinical trial methodology, counterfeit drug response, PDP development.
Capacity-building resources: WHO, DIA, AMANET, GCP training networks, Hackx (PH research).

3. Proposed Next Steps

Establish a Network website with public and members-only sections.
Develop a biannual newsletter and WHO to facilitate guideline reviews.
Conduct capacity needs assessment at NMRAs, focusing on trial reviews and ethics.
Identify ICDRA satellite meeting on pediatric medicines.
Create FAQs list on pediatric regulations and technical document on trials in developing countries.
Set up Steering Committee for Network governance.

4. Conclusion

The meeting recommended updating Terms of Reference, appointing a Steering Committee, and promoting the Network’s role in standard harmonization, capacity building, and ethical trials conduct for global pediatric medicine availability.

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