For all your Regulatory Affairs challenges
Processing of fee reductions for orphan medicines has been simplified by the EMA
Wednesday 15th of May 2013
The Irish Medicines Board is now accepting requests for Ireland to act as RMS
Monday 13th of May 2013
New EMA draft guideline on similar biological medicinal products
Wednesday 8th of May 2013
MHRA - FAQ on Patient Specific Directions
Thursday 25th of April 2013
FAQ on Patient Specific Directions
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IMB joint labelling
Thursday 25th of April 2013
The IMB has published a paper clarifying the procedure for dealing with joint labelling between the UK and IE following completion of an EU procedure
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UK National Apprenticeship Week 2013
Monday 11th of March 2013
Cambridge Regulatory Services supports UK National Apprenticeship Week 2013
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The revamped EudraGMP database may make GMP noncompliance statements public
Friday 8th of February 2013
The CMDh has updated its guidance on the classification of unforeseen variations (‘Article 5’ recommendations
Friday 8th of February 2013
Minutes have been published of a meeting between the CMDh and Interested Parties on DCP/MRP improvements
Thursday 7th of February 2013
The EMA has published a guideline on the non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins
Wednesday 6th of February 2013
The EMA has the updated the table template that accompanies the cover letter in MAA submissions made via the Centralised Procedure
Thursday 31st of January 2013
The EC has launched a public consultation on the proposed revisions to the EU GMP guidelines
Wednesday 23rd of January 2013
The MHRA has updated information on the transfer of existing herbal product licences to the traditional herbal registration scheme
Tuesday 22nd of January 2013
Concept paper on the need for a paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of acute heart failure
Monday 21st of January 2013
S10 Guidance on the photosafety evaluation of pharmaceuticals has been published by the ICH
Thursday 17th of January 2013
The EMA has issued a draft guideline on pharmaceutical development of medicines for paediatric use
Tuesday 15th of January 2013
The MHRA is to cease sending any email correspondence to advise regarding invalidated PLPI submissions.
Tuesday 15th of January 2013
The EMA draft guideline on setting health based exposure limits will impact on the manufacture of different medicinal products in shared facilities
Monday 14th of January 2013
The EMA’s eSubmission web client for electronic submissions is now available for registration
Thursday 10th of January 2013
EMA list of reference dates and frequency of submission of PSUR's
Thursday 11th of October 2012
EMA to accept biosimilar reference medicines sourced outside EU
Thursday 4th of October 2012
Revised guidelines on GMP
Wednesday 12th of September 2012
Eudralex has published three revised guidelines for good manufacturing practice:
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User Tests at £2,500*
Thursday 3rd of May 2012
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 to the same high standards that CambReg are known for; high success rates and fast turnaround times.
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eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency
Thursday 3rd of May 2012
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
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