'Truly Unique' Four-Agency Work-Sharing Pilot Aims To Cut Regulatory Burden & Speed Decisions
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...
The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.
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.
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.