Early Acces Support

In this section you will find relevant information for the early access to medicines for Rare Diseases such as the compassionate use of medicines.

  1. Showing 9 results for:
  2. Regulatory Science
  3. Early Acces Support
All Subjects

Joint EMA-FDA Scientific Advice

Published by IRDiRC

Regulatory AffairsEarly Access SupportScientific AdviceJoint EMA-FDA Scientific Advice

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and Biologics).

View this resource Bookmark this resource

Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives

Published by IACMHR Co., Ltd.

Orphan DrugRegulatory Science

this paper describes the current status of the regulation of rare diseases and orphan drugs in Asia and we comparatively analyze the regulation of rare diseases and orphan drugs worldwide in order to examine the challenges to and future perspectives on promoting research on rare diseases and development of orphan drugs in China and other Asian countries.

View this resource Bookmark this resource