We can find clarification
that USB encryption is optional Rewording information regarding password protection
of data vs. USB drive
To find updated guidance use the
below mentioned weblink
30 July 2012
RAPS: EU Regulators Expand Electronic Submission Program, Recommend Wider Use
After a four-month pilot period, EU regulators are proposing to make
permanent a program that allows applicants and sponsors of marketing
authorization applications to submit their entire dossiers
electronically.
The European Medicines Agency's (EMA) 27 July statement on continuing
the electronic application form (eAF) pilot program says the testing
phase was "successful," and use of the program will allow sponsors and
applicants to better control the quality and consistency of the data in
their submissions.
Applicants will still be allowed to use paper-based forms, through
EMA said it is "recommending" the use of the electronic application
forms, which may be used to apply for initial authorizations, variations
and renewals.
The pilot phase of the program
was first launched on 12 March 2012 by EMA, which said at the time that
the program was a "key step forward in the Agency's drive towards the
use of electronic applications as standard, using the Electronic Common
Technical Document (eCTD) format."
To find more information please use the below mentioned weblink
Exalon: CMDh releases updated guidance documents regarding submission of variations
The Co-ordination Group for Mutual Recognition and
Decentralized Procedures - Human (CMDh) has released some updated
guidance regarding the submission of variations in accordance to
Commission Regulation (EC) 1234/2008.
The update concerns the corresponding Q/A list (document CMDh/132/2009) which has been released as revision 13, dated June 2012 (available as "clean version" and "track-change version"). Compared with revision 12, the update contains the following changes:
- New Question 1.7 dealing with how changes in the SmPC/Labelling/PL should be identified when submitted with an applicant`s response: If such comments are made during the variation procedure a new version of the SmPC/Labelling/PL including all revised wording clearly identified, preferably using track-changes function should be provided. Note: It is not acceptable if the highlighted texts only identify the changes made in part of the variation procedure, e.g. since clock stop. Furthermore, it should be clear "what changes originate from the initial submission and what changes are proposed as a response to the received comments. The highlighted final texts circulated by RMS to CMS at the end of procedure should clearly identify all changes approved during the procedure"
- The response to Question 4.13 asking whether it is allowed to submit different class labellings agreed by PhVWP/CMDh as a grouped application has been transfered to the document "Examples for acceptable and not acceptable groupings for MRP/DCP products" which has been updated in parallel (see below)
To find more information please use the below mentioned weblink
EU validation criteria v4.1 (eCTD) & v3.0 (Nees) – Webinar Slides are available for Reference
The TIGes Harmonization has conducted EU validation webinar on Friday 13
July 2012.
The slides that were presented at
the Webinar are available for reference
Webinar Slides
Webinar Question answer
24 July 2012
THE eCTD SUMMIT: Are you Ready for the eCTD Mandate?
With
the FDA Safety & Innovation Act now signed into law, life science
companies will need to start thinking strategically about the impact of
the electronic submission mandate and how to quickly and easily comply.
Since most of the larger companies already submit electronically, the
greatest impact will be to the smaller, virtual companies that do not
have substantial IT infrastructure in place, and lack the overall
budgetary flexibility of their larger peers.
One
benefit for these smaller companies is that the FDA will provide 36
months for compliance for those companies that will submit original IND
submissions and amendments after final guidance is provided, instead of
24 months for NDA and BLA submissions. With that being said, the time
is now to prepare and plan for electronic submissions. Companies must
decide the best avenue for compliance whether it is bringing publishing
in-house, outsourcing, or utilizing a combination of the two.
To find more information please use the below mentioned weblink
Health Denmark: Guidelines for electronic applications
Although guidelines for requirements regarding.
how to submit electronic applications to the Board of Health, has long
been to find on the site, wants the Board of Health to focus on them
again.
Due to Board of Health experience with errors submissions, we want to refer to a rereading of the information here.
The full document concerning. Guidelines for electronic applications can be found here.
Short, we must recall that we distinguish between "applications" and
"submissions" so that an application may consist of one or more
submissions:
To find more information please use the below mentioned weblink
19 July 2012
CSC: What was the part in the middle? FDA's Module 1 v2 - Applications, Submissions and Sequences - By Joel Finkle
The question above is the response of Otto, the dimwitted assassin
brilliantly played by Kevin Kline in the movie "A Fish Called Wanda" when
presented with too many choices. While not really applicable to FDA's Module 1
version 2, which is coming regardless, it's the middle part that has caused a
lot of confusion, and it needs to get more complex, while at the same time
become more clear... got it?
Let's take it from the top: FDA's eCTD submissions have always included
three numbers: An application number (NDA, aNDA, BLA, or IND), a sequence
number (starting at 0000), and a related sequence number. There has always been
confusion about the related sequence number, and despite several FDA
presentations, sequencing has been a common source of errors in filing an eCTD.
To find more information please use the below
mentioned weblink
17 July 2012
EMA: New versions of the Electronic Application Forms for MAA-Human, MAA-Vet, Renewals and Variations has released
EMA: New
versions of the Electronic Application Forms for MAA-Human, MAA-Vet, Renewals
and Variations has released
EMA eSubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation (Guidance has been updated on 16th July 2012)
EMA eSubmission
Gateway: Questions and answers relating to practical and technical aspects of
the implementation (Guidance has been updated on 16th July 2012)
Croation Agency for Medicinal Products and Medical Devices (HALMED): Instructions for applicants for submitting the conventional dossier for medicinal products
The instructions mentioned in the document applicable only
for paper dossier.
Please use the below mentioned weblink to find more
information.
Subscribe to:
Posts (Atom)