Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE

Regulatory Cooperation Expanded

By Pharmaceutical Processing | June 19, 2007

The FDA, the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several important areas. At a meeting June 14-15, 2007, the FDA and the EU reviewed the past year’s activities under the existing Implementation Plan for the confidentiality arrangement. The ultimate goal of the initiative is to promote and protect public health, reducing regulatory burden and costs, and bringing innovative products to patients in a timely manner. Furthermore, important safety information about medicinal products is shared among the parties. Building on the achievements in cooperation on vaccines, oncology, and pharmacogenomics, it was agreed to expand further the interactions in the areas of pediatrics and medicinal products for rare diseases (“orphan drugs”). Furthermore, scientific dialogue has been widened to include extensions of therapeutic indications and risk management plans. Based upon the newly adopted pediatric legislation in the EU, a “Principles of Interactions” document that will facilitate the timely exchange of information on scientific and ethical issues for pediatric therapeutics has been finalized. The Implementation Plan on transatlantic medicines regulatory cooperation was revised to describe under what circumstances information will be shared among the parties. Following the Framework for Advancing Transatlantic Economic Integration between the EU and the FDA, new areas of transatlantic regulatory cooperation were discussed, notably regulatory cooperation on medical devices and on cosmetics. Discussions on these topics will continue. In an effort to avoid future disharmony, upstream regulatory cooperation on new medicines legislation was discussed. In addition, planning progressed on a Transatlantic Workshop on Administrative Simplification in Medicines Regulation. This workshop will be held on 28 November 2007 in Brussels, Belgium. Transatlantic regulatory cooperation under the EC, EMEA and US FDA collaboration has allowed each side to share common experiences and gain an understanding of each other’s regulatory system. Additionally, each side strives to reduce unnecessary differences in regulations and reduce associated costs to the consumer and industry. All parties concur that this activity continues to be a success in fostering transatlantic cooperation and promoting public health protection.

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Advertise
  • SUBSCRIBE