New reforms proposed by the Therapeutic Goods Administration (TGA) could see future prescription medicines approved in less than 300 days.
For Australians waiting for medicines which could potentially lead to better health outcomes and improved quality of life, it’s still a long wait. But the reduced timeframe (down from an average of 500 days) represents a significant development in facilitating earlier access to novel therapies in Australia.
The TGA believes a new pre-submission phase, to be conducted over 90 days, will ensure companies are clear on core requirements for an effective submission. This in turn should encourage higher quality submissions and eliminate unnecessary queues and delays in the evaluation process.
For the pharmaceutical industry, the proposed reforms are a positive outcome but it is clear that many challenges lie ahead.
In a recent information session held in Sydney, the TGA opened the floor to a few hundred regulatory specialists whose questions related to the underlying requirements which will underpin the new process.
Although pleased with the prospect of reduced timeframes, many expressed concern that 30 days does not provide enough time for companies to respond to a consolidated set of questions (a requirement in the 1st round assessment) – especially when consultation with overseas head offices and external stakeholders is required.
Other questions revolved around the TGA’s ability to manage the backlog of existing applications and how this will impact on new applications and the process which needs to be followed during the transition stage.
The TGA appreciate the proposed reforms involve a commitment from both the TGA and industry. The TGA must be able to offer effective resource planning, while companies will need to have processes in place to ensure overseas stakeholders can contribute to the company’s response to the TGA’s consolidated set of questions in a timely manner.
Will industry be able to deliver on this core requirement? And will the TGA be able to reassure Australians that standards for safety and efficacy of new prescription medicines will not be compromised with the shorter timelines?
The TGA is inviting external stakeholders to review the proposed changes and provide comment on its consultation paper by 22 March 2010.