Tuesday, 17 January 2012

What about some "Regulatory affairs in the US and EU" - Part II of X

Preface: In a continuation of what had been promised several months back and has started to be delivered exactly yesterday, I am here today once again to report my liking and disliking on the Regulatory Affairs course I did. This course, conducted by Pharmaceutical Training International is composed of 10 modules and throughout the coming days I'll be analysing it for the sake of those who might be interested in this professional area or might be looking for further education in that sense.

What is reviewed in the second module?

This turn the author focus on giving us an overview of the US regulatory system with good insight on FDA (one of the most respected regulatory agencies in the World). There is also the organics of how legislation comes to surface in the United States of America; and finally an idea on the different international markets (the most influential ones, obviously) apart from the US and the EU. There is a good focus on the Tripartite Agreement between the US, EU and Japan and the importance of the International Conference on Harmonisation which was already covered partially here in the following post [access here].

What about funny and curious facts revealed in this module?

The role of Theodore Roosevelt in bringing up the Pure Food and Drugs Act makes Roosevelt look even better in the picture; the chronological perspective of how the US evolved their food and drugs regulatory market is very resumed and straight to the point.

As good an example as the Thalomide, but this time US regulatory bodies are the ones making the mistake, is the one provided by the author when covering Elixir Sulphanilamide - earlier than the Thalidomide scandal though (but offering the premise to avoid a later tragedy to a much greater scale). Brief scopes on regulatory bodies and mutual cooperation, as well as evaluating how good they are considering the global reality we live in is given for geographical areas such as, Africa, South America, Australia and New Zealand, etc.

What about awesome quality information?

There is a very useful diagram of the typical project team schedule involved in reviewing a New Drug Application.

I really like the way the author concisely shows how a product can be approved in the US and then remain under pharmacovigilance with obligatory periodical submission of reports (I wasn't aware of such obligation at all)!

If I got it right, the public in the United States are conferred a lot more power when it comes to deciding on the fate of several drugs that are introduced in the market; that pleases me as they are the ultimate consumers. In the European Zone, in what concerns pretty much everything and not only biochemical regulatory principles, the individual governments lost their strength to decide; therefore, the public has no longer any type of decisional power, and all is left to a centralised EU committee that many times is completely unaware of the political, cultural, ecological and economical differences that are supposed to be taken into account. Even though the idea is to create an homogeneous Europe, Rome wasn't made in a day, and that plays a big role in messing up big time - this opinion is my own (entirely personal). 

I really liked the definitions and framework involving the roles of the Food and Drug Administration, the Drug Enforcement administration and The Office of National Drug Policy. Couldn't be shorter, couldn't be clearer!

Is anything missing?

This just came to the top of my head but it would be great if the coming revised edition, if anything like that is on PTI's agenda, to have an hyperlink that would give the reader the full meaning of any abbreviation without having to go back and forth whenever we forget any of the tens we are to learn.

Image taken from Benderly, B. L. (2007). "Experimental drugs on trial". Scientific American, 297, pp. 92-99.

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