'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.
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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.
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.