European Chemicals Agency annual report on helpdesk activities; BPR remains the regulation with highest number of enquiries received by NHDs in the past eight years. Overall trend shows that the number of queries addressed to the NHDs and ECHA decreased after peaking in 2020
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.
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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 first express interest in the initiative by using the Expression of Interest (EOI) form (MS Word Document, 123KB) to the relevant authorities. This should be done 3 - 6 months before the target submission date.