|
On 20 March 2006, EMEA published the Reflection Paper: "Chemical,
pharmaceutical and biological information to be included in dossiers when
Process Analytical Technology (PAT) is employed".
EMEA's PAT Team worked out this document in order to formulate
preliminary recommendations on how to hand in PAT-related information in
applications for or variations to Marketing Authorisations. Here, it is important to
the PAT Team not to build up unnecessary barriers. This Reflection Paper
is meant to provide guidance to those companies that plan a PAT-based
submission. The industry is called to comment on the content of
this paper, mainly since this working document is meant to be developed
further.
In general, the paper recommends to those firms intending to hand in an
application or variation containing PAT elements to
enter into discussion with the competent authorities at an early stage,
well before preparing the documents.The complete Reflection Paper can
be found here.
|
