Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


'Truly Unique' Four-Agency Work-Sharing Pilot Aims To Cut Regulatory Burden & Speed Decisions

Executive Summary

In response to an increasing regulatory workload and the greater complexity of new drugs coming through the pipeline, regulators from Australia, Canada, Singapore and Switzerland are inviting companies to take part in a work-sharing pilot for the assessment of applications for medicines containing a new chemical entity.

You may also be interested in...

Australia, Canada, Switzerland, Singapore Test Simultaneous Authorizations For Generics

Generic drug makers are being invited to take part in a trial that could help them get their products approved simultaneously in Australia, Canada, Switzerland and Singapore.

IGDRP Active Substance Review Guide Could Help Regulators – And Applicants

A group of regulatory authorities has published guidance for harmonizing members' reviews of active substances in drug applications so that it could be adapted for regulatory convergence worldwide – and so that generic drug firms could use it to anticipate regulatory expectations.

African Regulatory Harmonization Project Cuts Drug Approval Times And Saves Scarce Resources

A pilot project of joint assessments in East Africa has shown that regulatory review times for a number of branded medicines were reduced from one or two years to a median of seven months, representing a reduction of 40-60%. The project was part of the African Medicines Regulatory Harmonization initiative, which is intended to strengthen and align regulatory practices in sub-Saharan Africa. Part one of this article looks at the history of the AMRH, the 2016 Model Law that guides national regulators in implementing their own procedures, and the East African pilot that has shown joint reviews to be feasible at the regional level.





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