Pilot generic medicines work-sharing program

The International Regulators Consortium has initiated a pilot generic medicines work-sharing program.

The generic medicines industry is growing rapidly and becoming increasingly globalised, and generic medicines themselves are becoming increasingly complex. For these reasons, the consortium has selected the generic medicines approvals process as a priority area for exploring opportunities for international collaboration. This collaboration aims to assist the regulators to meet increased demands by maximising use of up-to-date technical expertise, and ensuring a consistent, contemporary approach to assessing the safety and efficacy of these medicines.

The objectives of the program are to:

• compare and better align regulatory requirements and approaches
• use available resources more efficiently
• reduce duplication and the number of regulatory hurdles
• increase the predictability of evaluation time frames
• increase consumer access to high quality, safe, and effective generic medicines.

The pilot program will include:

• sharing reviews
• staff exchanges
• identifying opportunities for regulatory alignment.

Such work is consistent with existing arrangements under each agency’s legislative framework for sharing information with other regulatory authorities.

TGA assessment of generic medicines

The TGA is committed to maintaining its current high standards for assessing the quality, safety and efficacy of medicines.

Generic medicine applications will continue to receive the same level of scrutiny by TGA evaluators, and will only be approved for supply within Australia on the basis of a decision by the TGA delegate.

It is expected that the collaborative work of the Consortium on generic medicine applications will serve as a 'proof of concept' for broader international cooperation.

Further information will be published on this important joint effort as it becomes available.