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- eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency
- User Tests at £2,500*
- Revised guidelines on GMP
- Public consultation paper - Paediatrics
- EMA to accept biosimilar reference medicines sourced outside EU
- EMA list of reference dates and frequency of submission of PSUR's
- EMA reporting requirements of ICSR's during interim period
- Implementation of the variation regulation
- The EMA’s eSubmission web client for electronic submissions is now available for registration
- The EMA draft guideline on setting health based exposure limits will impact on the manufacture of different medicinal products in shared facilities
- The MHRA is to cease sending any email correspondence to advise regarding invalidated PLPI submissions.
- The EMA has issued a draft guideline on pharmaceutical development of medicines for paediatric use
- S10 Guidance on the photosafety evaluation of pharmaceuticals has been published by the ICH
- 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
- The MHRA has updated information on the transfer of existing herbal product licences to the traditional herbal registration scheme
- The EC has launched a public consultation on the proposed revisions to the EU GMP guidelines
- The EMA has the updated the table template that accompanies the cover letter in MAA submissions made via the Centralised Procedure
- The EMA has published a guideline on the non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins
- Minutes have been published of a meeting between the CMDh and Interested Parties on DCP/MRP improvements
- The CMDh has updated its guidance on the classification of unforeseen variations (‘Article 5’ recommendations
- The revamped EudraGMP database may make GMP noncompliance statements public
- UK National Apprenticeship Week 2013
- IMB joint labelling
- MHRA - FAQ on Patient Specific Directions
- Good Pharmacovigilance Practices
- The EMA has published a new draft guideline on similar biological medicinal products
- The Irish Medicines Board is now accepting requests for Ireland to act as RMS
- Processing of fee reductions for orphan medicines has been simplified by the EMA
- Contact Us
Cambridge Regulatory Services
2 Cabot House - Compass Point Business Park - St Ives - PE27 5JL - Cambridgeshire (UK)
Email: info@cambreg.co.uk - t: +44 (0) 1480 465755 - f: +44 (0) 1480 463984
2 Cabot House - Compass Point Business Park - St Ives - PE27 5JL - Cambridgeshire (UK)
Email: info@cambreg.co.uk - t: +44 (0) 1480 465755 - f: +44 (0) 1480 463984