Tag Archives: National Regulatory Authorities for Drug Safety and Approvals NRA

Australia updates its world-class Pharmaceutical Benefits Scheme

Newsroom24x7 Desk

medicines 2 Sydney : Facts speak for themselves on drug listings when it comes to Australia’s world class Pharmaceutical Benefits Scheme (PBS). It is supported by world-class drug approval systems that balance fast access to the latest drugs for patients with strict public safety protections that are based on clinical evidence, not just the claims of drug companies. The approval systems also include safeguards to ensure taxpayers are not overpaying for drugs that do not deliver on what they promise patients.

This approach has allowed Australian Government to deliver on its promise to list new drugs quickly, with 798 new and amended listings added to the PBS since we came to office in 2013. This is the more than double the 331 new and amended drug listings delivered in Labor’s final term in half the time.

Unfortunately Australia is disadvantaged because drug companies often delay bringing new medicines down under – sometimes by up to 15 months – in favor of making applications in more-lucrative markets such as the US and Europe first. For example, the recent independent Expert panel review of medicines and medical device regulation found Australians waiting on average about six months longer than the US and Europe for drug companies to apply to list new medicines here. This is despite Australia being on average 90 days – or three months – faster to approve new drugs as safe than world-leaders such as Europe. A report on time analysis done by Ministry of Health, Australia revealed that these submission gaps may be contributing to a perception that the TGA (Therapeutic Goods Administration) was slow to approve new drugs for market, as observers would not necessarily be aware the dossier was not submitted in Australia at the same time as it was submitted in, for example, the US.

So, the government has determined to overcome this and has started working with the entire pharmaceutical chain, including consumers, to institute reforms. This includes current consideration of recommendations of an independent review into strengthening and streamlining Australia’s world class drug approval systems so that they deliver even more for patients.

Discussions about drug listings are often a difficult and emotive issue and its important patients are able to access the facts, not just perceptions and propaganda. But interesting facts which catch attention are – Europe is one of the biggest medicine markets in the world. Australia (TGA) – takes an average of 391 days to approve a new drug as safe Europe (European Medicines Agency or EMA) – takes an average of 481 days to approve a new drug as safe.

The TGA outperforms the EMA (European Medicines Agency) and a number of medium sized regulators in terms of its median approval time. In terms of predictability of approval times, the TGA, along with the EMA, is setting the benchmark for other NRAs (National Regulatory Authorities for Drug Safety and Approvals).