Thursday, 19 January 2012

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

What is reviewed in the third module?

This module 3 covers  in detail the development of a medicine from its initial surfacing from the production laboratory until it gets its shape as a finished product. In addition, it stresses out the relevance of the ICH (see prior post) on harmonising the different studies and steps to a product to be given the go-ahead signal. All in all one, the reader should expect a lot of directives, council names, regulatory requirements as well as documents, and a crazy bunch of theory as part of this module.

What about funny and curious facts revealed in this module?

One will learn that the development of a new product takes approximately 12 years and that even if the new product is selected to undergo full development, its success is not entirely guaranteed, as at each stage of the non-clinical and clinical phases the products can be withdrawn. 

Surprisingly, it was not until the Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989, conducted by the World Health Organization (WHO) that adequate and directional plans for developing harmonised guidance for testing new medicinal products became a reality.

With this module one learns that all chemicals known to cause cancer in humans, also cause cancer in rodents.

Finally, the author shows briefly but concisely that the US clinical trials process offers several advantages over its European counterparts, from speed of assessment to better communication between the involved parts. But as the author admits, by the time FDA is in possession of the new drug application FDA already knows where and how to work in order to help improve the quality of the application, subsequently the quality and safety of the product.

What about awesome quality information?

Here is a very summarised list of what you can expect from this module in terms of high level information: 

a) The clinical development stage is divided into four broad stages known as Phase I, Phase II, Phase III and the post-marketing studies Phase IV.

b) The bodies of which ICH is comprised of are clearly listed and their individual participation is very well described.

c) To support a specific duration of exposure to a new product there has to be at least an equivalent exposure in animal toxicology studies.

d) One learns a bit about reproductive toxicology, mutagenicity studies and carcinogenicity studies.

e) Also, the purpose of conducting clinical trials is perfectly resumed.

f) Phase I (human pharmacology), Phase II (therapeutic exploratory), Phase IIIa (therapeutic confirmatory), Phase IIIb (therapeutic use), Phase IV (therapeutic Use), Post-marketing surveillance (PMS) studies - these summaries are just great and the overall table is of good use!

g) GCP, as it stands today, is based on major elements highlighted by the Declaration of Helsinki.

Is anything missing?

Probably a little bit more of enthusiasm if that is possible in a serious matter as regulatory affairs. The reason why I say it is that the amount of information is so dense and condensed in this module that one really needs to take several notes and go for a personal framework in order to organise (first) and then understand (second) the lots of information provided.

I personally believe that there are way too many things going on and being condensed in Module 3; things could be better divided or maybe a preliminary module about GLP, ICH and the like would help shape ideas for the rest to come.

Picture taken from Wikipedia's page

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