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Australia is set to get the green light to roll out the Pfizer vaccine any day now. There is a complex process behind this.

7 January 2021 To address this worldwide public health crisis, Access Consortium members are collaborating to advance the regulatory science needed to support the rapid development of diagnostic tests, as well as vaccines and treatments against COVID-19. Members are committed to sharing vital information as we all investigate and evaluate medical products for quality, safety and efficacy, and strive to ensure that the benefits of any new medical product outweigh its risks. During these unprecedented times, the Consortium is building on its proven ability to benefit from work-sharing that has ...

Apply for a licence to market a medicine in the UK How to license a medicine for sale in the UK, including applications through national and international routes. From: Contents Print this page This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures. Which procedure to follow There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market a...

Access New Active Substance (NAS) Work Sharing Initiative The New Active Substance Work Sharing Initiative has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. From: Contents Print this page By engaging in these partnerships, Access is able to co-ordinate regulatory review procedures, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products. Assessment procedure The applicant should firs...

Access Consortium The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic. From: Print this page The consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements. The original consortium, formed in 2007 and known as ‘ACSS’, comprised the national regulatory authorities of Australia, Canada, Singapore and Switzerland. In October 2020, the MHRA joined, and the group’s name wa...