The last monthly activity report for the Certification of Substances Division (DCEP) is now available for July 2016.
A document has been prepared to provide guidance on the implementation of ICH Q3D on elemental impurities in the context of Certificates of Suitability (CEP).
The application forms for the submission of new CEP applications and for requests for revision/renewal have been slightly revised.
The EDQM is preparing its next international conference on its Certification Procedure, which will take place in 2017 (final date and European venue to be confirmed in the coming weeks).
A document has been prepared to provide guidance on the approach taken by EDQM when carrier oils are used with antioxidant in omega 3 type substances.
The EDQM has just published its 2015 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed. In her foreword, EDQM Director, Dr Susanne Keitel, comments on the year’s events, achievements, and thanks all involved for their dedication, expertise and support.
The workshop on the IGDRP initiative, held on 13 May 2016 at the EDQM premises in Strasbourg, brought together 80 regulators, industry representatives and other stakeholders from 29 different countries (including Australia, Brazil, Canada, China, India, Japan, Republic of Korea, Mexico, South Africa and Taiwan).
The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ».
The EDQM will be attending CPhI China in Shanghai from 21-23 June 2016. Come and meet us on Stand E1A19 and learn about the 9th Edition of the European Pharmacopoeia!
The EDQM document PA/PH/CEP (16) 20 explains the impact on CEPs of the revision of titles of existing monographs to implement the Ph. Eur policy for hydrates included in the Ph. Eur. style guide of 2014.
The EDQM has revised the document “Use of CESP to submit electronic documents to EDQM”. The document has been adapted to be in line with CESP 2.0.
After public consultation, the EDQM has established its roadmap for the submission of CEP applications in electronic format for the next 4 years. This roadmap represents a major change to current practices.
Following a technical issue with the RSS feeds, we are pleased to announce that they are now all operational.
Within the framework of the 3rd meeting of the International Generic Drug Regulators Programme (IGDRP) in Strasbourg, the EDQM is pleased to organise a one-day workshop on the IGDRP initiative on Friday, 13 May 2016, when industry representatives and other stakeholders will have the opportunity to interact directly with regulators from around the world.
A review of the pricing policy for the activities associated with the procedure for Certificates of suitability to the monographs ...