There's a Common Technical Document or
CTD that has been developed for this harmonization idea.
The idea is to find things that are
acceptable for regulatory authorities within the three regions.
Also, this may not define the entire content but
it gives some ideas about where the harmonization will be most effective.
The objectives here are for industry to reduce
the time and resources needed to compile applications,
have an ease of preparation for electronic submissions.
For regulatory authorities, facilitate reviews in a more timely basis,
improved communication with the applicant and simplify
exchange of information between the different Regulators.
Do your acronyms are failing the Common Technical Document?
When we look about what the different organizational modules that we're talking about,
the idea is that with the CTD and again,
this module's three, four, five,
and two, all of these would be
essentially part of that CTD underlying it all be raw data.
So, for example, the Nonclinical review,
Clinical review, written summary is in Module two.
Quality data reports here in Module four, nonclinical data.
Then, Module five, clinical data, study reports.
As far as the Regional Administrative Information
and how this might be applied, that's not part of it,
that gets essentially customized for the country that is going to be applied.
So, we think about this harmonization now, and in the future,
there are new areas that need to be focused on as well besides
just the initial phases to get say the difference of phase one,
phase two, phase three and how they might relate using an FDA regimen to other countries.
There's obviously post marketing programs under some ideas of pharmacovigilance,
particularly opiates issues that come up as well.
Pharmacogenomics, biomarkers and gene therapy, all major issues.
Then, a continued effort between harmonization and
prevention of new interregional disharmony.
Basically, avoiding unilateral development of
requirements in specific areas and try to keep things as consistent as possible.
In terms of continuing this work with globalizing this idea of the harmonization,
there's a Global Cooperation Group.
So, that has a wider array beyond just the three major regions.
So, we have the Asia Pacific Economic Cooperation area,
we have the Gulf Cooperation Council,
we have the Emirates,
in Saudi Arabia and other places to buy counter involved.
Then, a Pan American Network for Drug Regulatory Harmonization generally South American,
that space, and then Africa as well.
So, the idea is to have essentially,
there be an evolution so that this process can go forward
and make it more of a standard across the entire global pharmaceutical market.
There's also Regulators Forum that was started in
2008 including representatives from Australia,
Brazil, China, Taiwan, India,
Russia, Singapore, South Korea;
many which are not part of that harmonization initiatives already.
Their, again, their focuses are very similar and the hope
is that these things can come together to create a truly cooperative group.
This concludes this module on looking at
the harmonization of regulatory regimes for the pharmaceutical market.