FDA/EC/EMEA joint inspections
Executive Summary
FDA has agreed to collaborate with the European Commission and European Medicines Agency on pilot projects involving joint inspections of pharmaceutical manufacturers in the U.S. and EU and of manufacturers of active pharmaceutical ingredients in "third" countries, the Transatlantic Economic Council announced at a May 13 meeting in Brussels. The organizations will also pilot the exchange of inspection results to better identify API manufacturers in third countries and will accelerate efforts to determine "to what extent dedicated production facilities are necessary for certain pharmaceuticals," according to a TEC summary. Formed in 2007, the TEC is designed to foster closer economic standards by harmonizing standards and is comprised of U.S. Cabinet members and European commissioners
You may also be interested in...
CBER To Train Foreign Regulators On Biologics Review
October seminar is planned in response to international requests; CDER will hold companion forum.
David Now Goliath? Made In China PD-1s Sought After By Multinationals
From relatively little-known to high-flying, hotly pursued targets by global pharma players, Chinese domestically developed immuno-oncology drugs are ascending in both value and attractiveness, both inside China and far beyond.
How Heads Of Indian Firms Rallied To Sustain Global Supplies Amid COVID-19
The leadership of top Indian firms recounted at the IPA Forum how they got together on a joint 45-minute call daily in the early phase of the pandemic to collaborate and ensure uninterrupted supplies of medicines both in India and globally. The executives also shared views on telemedicine and digitalization trends at the event.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: