Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake

Two Applicants Have Completed The US-EU Parallel Advice Process So Far

Executive Summary

While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.

You may also be interested in...

AAM And Medicines For Europe Urge Transatlantic Framework For Complex Generics

A proposed joint framework for complex generic development between the US and EU could reduce study duplications by eliminating the need to use locally approved comparators, a move that has been embraced by other regions and international organizations.

IGBA Kicks Off Biosimilars Week With New White Paper

The IGBA has kicked off its third annual global biosimilars week awareness campaign with the release of a white paper that urges stakeholders to recognize and adopt recommendations from the WHO’s latest revised biosimilars guideline.

FDA And EMA Collaborate On Advice For Complex Generics And Hybrids

The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts