0:28
What we mean by that, is to specifically we're talking about Asia Pacific region,
we're including in that range of countries, India,
the Philippines, South Korea, Taiwan,
obviously China, Hong Kong,
Macau, all fall in that space as well.
For different emerging regions,
we get to Argentina,
Brazil, Chile and Mexico.
For the Middle East and North Africa,
we get to Egypt, Pakistan,
Saudi Arabia, and Turkey.
Sub-Saharan Africa, including South Africa.
Then in Eastern Europe, Russia.
1:06
So, when we think about different models for drug regulatory assessment,
there's really two different licensing models that countries can fall in to.
The model of licensing system based upon submission of evidence,
registration and reference countries,
which can include the United States and other places in Europe.
Or the model of licensing system based upon a full assessment of
new drug applications including biological products,
is going to be much more intense.
One thing that is trying to make this work better is to
focus on what's known as a Global Harmonization Initiative,
to really get to a point where the regulatory regimes
that are introduced for new pharmaceutical agents can be much better standardized,
so it's not quite so pluralistic or a hodgepodge.
So, it is a very pretty picture,
the human body is a little more common than necessarily all the colors of the flag.
1:59
So, when we think about this idea of an International Conference of Harmonization,
that's IHC, what's the definition and background.
Several things to keep in mind as a joint regulatory project,
the leaders of this are the EU,
Japan, and the United States.
The goal is to improve through harmonization, efficiency of development,
registration of new medicinal products as much as possible bases on scientific consensus,
and look for a commitment by regulatory parties to
implement the harmonization recommendations.
2:32
There are six official parties that are co-sponsors directly involved in this.
So, from the sense of authority and research-based industry,
we have the EU, Japan and the USA.
Each of them having their different regulatory components involved.
So, for example, the USA we talked about before,
the EFTA, as well as the Pharmaceutical Research Manufacturers Association.
Same idea comes into play here,
we have both industry as well as regulatory agencies represented.
The official observers for this activity, for harmonization,
is the World Health Organization as well as the European Free Trade Area,
the EFTA, and from Canada,
the Health Protection Branch.
3:11
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.
Bryana MayerLecturer
Stephen T ParenteProfessor
