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news.The European Union (EU) will implement a decentralized procedure for speedy clearance of generic drug applications under the International Generic Drug Regulators Pilot program.
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Under the decentralized procedure, the medicines are authorized simultaneously in more than one country.
Australia, Canada, Chinese Taipei and Switzerland are participating in the first phase of the three-year pilot, with the other members, Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa, having an option to join later.
EU said in a statement: "By offering to share its assessment reports, the EU aims to reinforce collaboration and information-sharing between regulatory authorities across the world, contributing to facilitating and strengthening the scientific assessment process for medicines.
"This should enable medicines to be authorized in different territories in a coordinated way at approximately the same time."
The European Directorate for the Quality of Medicines & Healthcare and the World Health Organization are the observers of the pilot.
The IGDRP was launched in 2012 to promote collaboration in generic medicines regulatory programs.
The ‘regulatory convergence’ of generic drugs is expected to reduce the burden on the individual regulatory authorities to process and approve numerous applications.
In addition to the pilot decentralization initiative, EU is also exploring work sharing possibilities in the area of active substance master file, inspection of sites conducting bioequivalence and bio-analytical studies and information sharing on pharmaceutical quality issues.