MHRA: New Recognition Routes with Seven Regulatory Partners
The MHRA is further extending its regulatory network. A new regulatory recognition framework for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. It should be in place by the first quarter of 2024.
The EMA, the US FDA, Swissmedic, the TGA, Health Canada, the Japanese PMDA, and the Singapore SHSA are renowned partner authorities. The framework is designed to use their expertise and decision-making. As a result, cutting-edge medicines approved in other countries will get to UK patients more quickly, with cost reductions and streamlined regulatory processes for the industry. Still, the MHRA announced to maintain rigorous scrutiny and retain the authority to reject applications if the evidence provided is considered insufficiently robust.
Another MHRA win: At the time of the UK’s exit from the EU, the MHRA introduced EU ‘reliance’ routes, to ensure that patients could continue to have timely access to new treatments. These temporary routes are due to expire at the end of 2023 and can now be compensated with the latest recognition routes.
Work is also underway to establish similar routes for medical devices. The UK government has assigned £ 10 million to establish such frameworks.
The Australian TGA already backs the introduction of this new international recognition framework. One of the TGA international engagement strategy 2021 - 2025 goals is to utilise international networks to monitor product safety and quality and maintain supply chains for Australia.
Source:
MHRA: News
TGA: News
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