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 last monthly activity report for the Certification of Substances Division (DCEP) is now available for April 2016.
The EDQM has revised the document « Guidance for electronic submissions for Certificates of Suitability (CEPs) applications ».
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 ...
The EDQM is proud to announce that after a comprehensive three-day certification audit, the French certification body AFNOR (AFAQ), decided in December 2015 to renew its ISO 9001 certificate granted to the EDQM.
The overall objective of the meeting was to strengthen international co-operation and share experiences in the field of API inspections.
A new document is now available which provides clarification on the processing of complaints arising from the implementation of the CEP procedure and its related inspection programme.
Applicants and Holders of certificates of suitability (CEP) are responsible for maintaining the details of the contact person up-to-date for their applications, to ensure timely and efficient communication with EDQM. The document “Changes in contact details to be notified to EDQM” (PA/PH/CEP 10 (86) 1R) has been revised...
EDQM website has gotten a new look with a mobile-friendly design The EDQM has redesigned its website using Responsive Web Design techniques, which means the look of the EDQM website will...