Quote:
Originally Posted by jfman
You can't be "a month late" approving a process simply because other authorities covering other areas approved it sooner - potentially with a different threshold for authorisation.
France are clear making a hash of it but that doesn't make us "successful" and the more we spend looking down on them the longer our government get away with not taking up to the (I think) 2.34 million a week Boris needs for his latest bombastic target.
Unless of course those pesky Civil Servants are at it again...
|
There can be quite big differences in the approval processes for drugs in different countries (and blocs of countries)
For example, the FDA (USA) assesses the efficacy and safety of a drug alongside the permitted prescribing information (who can have the drug, what conditions mean you can't and how the drug should be administered as examples) The EMA in contrast has a stepwise process where safety and efficacy are assessed first, then the marketing information. In another example, the EMA look for and do a lot more risk assessments than the FDA ('based on the known science and what limited trial information we have, is this drug safe for patients with disease x, y or z')
The EMA uses local country assessors for drugs alongside their central assessors to ensure that their decisions are compatible with local regulations and guidelines. This of course will slow approval but the advantage is there is a single market for drugs so they can be targeted to the regions of greatest need (if you like that kind of thing) With the MHRA, this 'cross-approval' wasn't needed, hence the faster approval.
There are moves to create a global standard of drug approval so the information package the pharma companies need to provide is constant (
https://www.ich.org/) but this has been going on for years with only limited success