2011-05-31-世界卫生组织-PmRN_newsletter_2_2页_368kb

报告摘要

PmRN Newsletter Summary

Introduction

The Paediatric medicines Regulators’ Network (PmRN) was established to address the need for research and development on paediatric medicines. It consists of representatives from National Medicines Regulatory Authorities and focuses on key areas such as clinical evaluation, marketing authorization, formulation development, and safety assessment of paediatric medicines.

Activities & Achievements

The PmRN website was launched (http://www.who.int/childmedicines/paediatric_regulators/en/) to provide information on the network's activities.
Plans for a paediatric workshop at the 14th ICDRA meeting in Singapore (November 30-December 3, 2010).
The WHO Model Formulary for Children and updated UNICEF/WHO sources and prices for selected child medicines were mentioned.

News

The PmRN Steering Committee was formed with experts from Singapore, Tanzania, the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA). Dr. Agnès Saint Raymond from EMA chairs the committee.
A web site was set up specifically for PmRN, facilitating coordination and resources for marketing authorization, formulation, and safety.

Country Interview

An interview with the National Regulatory Authority of Tanzania (Tanzania Food and Drug Administration) will explore local regulatory procedures and resources for paediatric medicines. Topics include ethics, GCP, dossier submission, and capacity building.