The last monthly activity report for the Certification of Substances Division (DCEP) is now available.
EDQM has revised the policy regarding the use of a CEP to describe a material in an application for another CEP.
The last monthly activity report for the Certification of Substances Division (DCEP) is now available for August 2016.
The guideline ICH M7 on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has been adopted...
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 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 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 EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ».