International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines

More specifically, the TGA is seeking public comment​ until May 22 on the adoption of ICH guidelines Q9 and Q10, which deal with quality risk management and pharma quality systems, as well as EMA guidelines that will replace other, older guidelines first developed by the TGA.

For instance, the TGA is looking to replace parts of its guideline on the quality of modified release products with the EMA’s guideline on the quality of transdermal patches. Australia may also see the EMA’s guideline on Active Substance Master File Procedure come into effect soon.

If the guidelines are adopted, some of them, such as the EMA’s most recent biosimilar guideline​ from last October, would be adopted by the end of the month to replace a guideline that had been in use since 2000. Others, though, like the EMA’s guideline on biosimilars containing biotechnology-derived proteins as active substance, might not make it into the TGA’s regs until July.

This isn’t the first time the TGA has sought to be more aligned with the EMA. Back in 2011, the TGA adopted 15 other EMA guidelines​ on residual solvents, genotoxic impurities and other GMP topics.

The latest announcement seeking comment on the adoption of these EMA guidelines comes as the TGA announced last October that it would conduct an independent review of its medicines and medical device regulations in general as a way to streamline its efforts.

The review seeks to identify areas of unnecessary, duplicative, or ineffective regulation that could be removed without undermining the safety or quality of medical products, as well as to find opportunities to enhance the regulatory framework so that Australia can respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.