In the Q&A section on its website the European Medicines Agency publishes the most frequently asked questions regarding the procedures of centralised marketing authorisations. The answers are updated as necessary and therefore represent the authority's current thinking about the topics concerned.
The EMA has now compiled the questions and answers in two documents which can be seen as "procedural guidebooks". These documents were first published in 2009 and 2008. The updated versions were published on 14 September 2011.
One of the documents contains a topic collection of all questions related to the centralised pre-submission procedures. In total, it contains 54 questions and answers. The second document summarizes in 40 questions and answers information about the centralised procedure for generic/hybrid applications.
The date when the answers were updated is indicated after each question. The documents also link to the relevant guidelines, directives and regulations. The numerous forms required for the application are referred to in the text and are also linked. Therefore they are easily accessible which saves the applicant time-consuming searching.
Although each question and its answer can also be found in the respective sub-section (thematic classification) of the EMA website it is really useful and helpful to have the Q&A collection with its links available in one document.
Please see the original documents for further information:
Note: During the ECA Education Courses "Marketing Authorisation Procedures in the EU and the US"in Berlin, Germany, from 11-13 October 2011 you will get an excellent overview of the European and US American procedures.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)