Australia Proposes New Risk-Based Approach to Medicine Variations

Regulatory NewsRegulatory News | 08 June 2017 |  By 

Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement.

"These requests are known as 'notifications' but still require an application to the TGA," the regulator explained. "These lowest risk variations do not require evaluation but legally must still be approved by the TGA before implementation by the sponsor."

TGA says that such a risk-based approach to the management of variations to medicines, which will be only for changes that do not impact the quality, safety or efficacy of a medicine, will reduce regulatory burdens on industry, reduce unnecessary assessment work for TGA and allow for variations to take effect more quickly.

A list of variations that are acceptable for notification only will be developed, TGA adds, noting that it is looking to generally align with European Medicines Agency requirements.

However, changes to Australia's Therapeutic Goods Act 1989 are needed to implement this new notification process, TGA says, noting that it has introduced into Parliament a bill to amend the act, as well as amendments to the Therapeutic Goods Regulations 1990 outlining the first set of changes proposed as notifications.

Other upcoming regulatory reforms were also outlined by TGA last September.

Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected


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