Thursday, 26 April 2012

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

Preface: And here we are again, two modules to the end of this long review to PTI's course on Regulatory Affairs - Europe/USA. I have been quite busy with lab work, thus couldn't really update this review as frequently as I wanted, yet I promise you all that soon we'll reach an end. We have Module 8 on review today, module 9 will come soon and then the final module with a very brief overall opinion. Nonetheless, today, expect a dense slightly boring, yet very important module.

What is reviewed in the eighth module? The safety and quality of pharmaceutical products. That simple, dead simple: labeling a product, pharmacovigilance, quality. And also a little on the counterfeits.

What about funny and curious facts revealed in this module? The author refers something of great importance that everyone should have in mind, and I quote "For those outside of regulatory affairs, the labeling of medicines is often considered as a marketing opportunity, however there are strict guidelines in place to prevent this."

In the USA and in what concerns leaflets "The legislation has recently been updated and the FDA has produced draft guidance to assist manufacturers, healthcare professionals and consumers with the affect this will have on labelling." Important mostly because this system had been unaltered for over 20 years.

"The reporting of suspected ADRs [adverse drug reactiuons] is reported in different ways from country to country. In the UK, the MHRA [Medicine and Healthcare products Regulatory Agency] have an established system called the Yellow Card Scheme".

"The use of an inverted black triangle next to the name of the product on marketing materials has long been used in the UK for products where the risk/benefit profile is under scrutiny."

What about some awesome quality information? 
The requirements for the labeling of products in the EU is provided in Title V of Directive 2001/83/EC. Since 2005, it is now a requirement to provide information about the product in formats for partially sighted or blind people.

Now it is mandatory for a company to carry out readability testing for all new MA applications after 30th October 2006, and to retrospectively improve the readability of PILs for products approved before this date – unless a justification for not testing can be provided.

The legislation that is applicable to the labelling of prescribed pharmaceutical products in the US is taken from the Federal Food Drug and Cosmetic Act and Part 201, Title 21 of the Code of Federal Regulations (CFR).

About the Periodic Safety Update Reports - "In the EU, the submission of PSURs is required at 6-monthly intervals for the first two years upon receiving an MA [market authorisation] and then annually for the next three years,"... "In the US, the current frequency for submitting PSURs is quarterly for the first two years and then annually for the rest of the product’s lifetime."

Is there anything missing? I honestly don't think so.

Image taken from healthcare packaging, [ ], last access on the 04th of May 2012, last update unknown.

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