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Regulatory News...
April 26, 2012
eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency
The European Medicines Agency’s eSubmission Gateway is now live for all applications for centralised marketing authorisations for human medicines. The eSubmission Gateway is an electronic submission channel that allows applicants to submit documents supporting all types of applications for human medicines to the Agency securely over the internet in the eCTD format. Companies wishing to [...]
April 19, 2012
User Tests at £2,500*
User Tests at £2,500* are being offered by CambReg throughout the months of May and June. Due to a postponement of a major project, CambReg’s UT Team will be able to dedicate time to your project instead, at a bargain rate, for this short period of time. The work will of course be carried out [...]
April 3, 2012
EMA new fees
Fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are increasing by 3.1% on 1 April 2012. Full details of the new fees levels are available in the revised fee regulation, its implementing rules and the corresponding explanatory note on fees, published by the EMEA. These documents include the new fees for [...]
April 3, 2012
MHRA – flexibilty in the submission format of labels and leaflets
Following consultation with medicines trade associations and member companies the MHRA has announced some procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets. For a summary of the changes and further guidance & examples concerning new MA applications as well as Type 1B & Type II variations download the new [...]
Cambridge Regulatory Services
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Cambridge Regulatory Services has expertise and experience to provide a full range of regulatory affair solutions and is dedicated to delivering the highest quality support, helping your company to gain approval for your medicine pipeline in a timely and cost-effective manner.
Helping at any stage in the life cycle of a medicine, from discovery to patent expiry and beyond, Cambridge Regulatory Services focuses on achieving full commercial potential for all products..
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