The MHRA together with our European colleagues would like to invite comment on a proposal to improve regulatory information submissions. The Electronic Submission Roadmap aims at establishing secure, consistent and efficient electronic submission processes for medicinal products for human and veterinary use across the European medicines regulatory network. It aims to define the way the regulatory information on medicinal products is submitted by applicants electronically, and how they are received, validated, processed and distributed by regulatory authorities. It is hoped that initiatives like this will lead to more harmonised and efficient submission processes across Europe.
The document below details proposed deadlines and we would like to know how achievable these are for your organisation.
To determine the achievability a survey is being distributed by all European Union member states.
Industry Survey – EMRN eSubmission Roadmap (external link)
The deadline for your response to be included in the consultation is 31 October 2013. For more information please contact Matthew Hillier, matthew.hillier@mhra.gsi.gov.uk.
Download documents:
Electronic submissions consultation