Notes from the ICH Meeting in Washington

Recently, the second regional ICH meeting was held in Washington, CD. This was the second regional meeting and the first in the US (the first overall was held in Japan and you can find the proceedings on the ICH website) since the ICH has adopted the approach of smaller, more frequuent, regional and public meetings to discuss life sciences standards.

This approach seems be a good one, and I'm hoping the ICH keeps this direction to give sponsors and vendors in the industry an opportunity to interact directly with regulators.

Anyway, an unnamed source to whom I'm very grateful allows me to post their notes below.

· eCTD Next Major Release

o Requirements are expected to be completed by ICH November meeting in Brussels

o “Substantial” changes expected in:

§ Life cycle management

§ 2-way communication with authorities

§ Message technical architecture

· Message standard development will be done in collaboration with HL7 scope

o There is a recommendation that ICH, HL7 & ISO from a joint initiative to progress the eCTD Next Major Version

§ This will result in the next eCTD major release as an ISO standard

o Anticipated : Extend HL7 RPS support (no further details)

· PDF Version

o Will remain at v1.4

o Migration from 1.4 to 1.7 was discussed due to regional use in M2-M5

o Pros/cons of migration will be discussed in 2009

· Media guidance withdrawal

o ICH withdraws:

§ Floppy disk

§ DVD-RAM

§ CD-R

o Acceptable formats will be defined at the regional level based on the region’s architecture

· Global Cooperation Group

o Sub-committee of ICH experts which focuses on working with non-ICH regional experts

§ “Promote better understanding of ICH and ICH guidelines”

o Goals include

§ Reduce differences in technical requirements

§ Promote international movements of safe and effective pharmaceuticals

§ Conduct clinical trials that meet international standards

· DSUR (Development Safety Update Report)

o Analogous to the PSUR

o Harmonization of format, content and scheduling across 3 regions

o Single DSUR for one Investigational Drug

§ Decreases number of reports generated

§ Improved consistency

§ Regulators receive same information at same time

o Goal is to complete step 4 by June 2009

Bare in mind that these notes are provided as a courtesy and are not a substitute for the actual proceedings which will eventually be posted by the ICH on their website.

In general, there are a few interesting things here. My thoughts are that the two biggest announcements is that the next release of eCTD appears be at least being primed for some sort of alignment with RPS. Two-way communication is a real clue as this was previously thought to be a feature unique to RPS. Whether this means eCTD will actually be RPS compatible or just feature some of the same benefits to make submission building, review, and feedback cycles analogous is still unclear.

The other big items are getting agencies to consider DSURs as an internationally accepted standard for PSURs. This would allow companies to greatly simplify post approval updates, so that once a drug product is globally approved, maintenence should be greatly simplified. This is obviously REALLY cool!

Agree with my speculation? Or do I not have a clue? Let me know below! :)

eCTD and 21CFR Part 11 Compliance

So as a technologically advanced sponsor, I've decided to embrace the future and send my next US submission to the FDA in eCTD format. I'm researching all of the FDA and ICH guidances, and I feel good about my ability to make all my links blue, create an STF, generate an index.xml file, etc. All I need to do is find a great set of software solutions to help me with the technical challenges associated with submitting in eCTD. But with great software, comes great responsibility! After talking to my colleagues in the CMC department, I realize that my shiny new software better be able to comply with the FDA's 21CFR Part 11 requirements!

Here is a common question posed to eCTD publishing/DMS/other types of software vendors in our field: "Is your software 21CFR Part 11 compliant?" Of course, they all reply "totally!"...or something more professional-sounding. However, this doesn't mean that you don't have to worry about Part 11 requirements. It is certainly possible to implement a software system that is compliant with Part 11 in a way that isn't compliant with Part 11 (confused?)

The FDA released a document called “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application” way back in 2003 that outlines their: ”… current thinking regarding the scope and application of part 11…”[1]. There are five main areas within this scope, that are listed on pages 6 through 8 of the document [1].

I’m not going to be able to tackle the details of each consideration in one blog post. Here is a list of what the FDA considers important and how it might relate to our eCTD-supporting software:

• Validation: You have to make sure your software is installed and working within your business process.
  
• Audit Trail: Your software must track all of the actions performed by all users.
• Legacy Systems: Your old software doesn't have to comply with the newest rules as long as it still meets the old requirements. (Probably not relevant for this example, because we are talking about new software.)
• Copies of Records: When you are asked to provide Part 11 - related records to the FDA, make sure they are in a convenient format and easy for the agency to read/interpret.
• Retention of Records: If you're going to archive your old records, then make sure they retain their meaning.
  

[1], http://www.fda.gov/cder/guidance/5667fnl.pdf.