Article by Tim Bisley
The discovery and creation of a new drug will be an exciting time for everyone involved in the process from the pharmacologists and chemists involved in researching and refining the particular drug or cure to the actual patients and sufferers who have been waiting for either a breakthrough cure or a new and improved drug or treatment that makes their lives much more comfortable and stress-free.
The final stage of any new drug being made available will be the licensing or pharmalicensing stage of development. This is the stage where a drug and all of its related documentation are submitted before a licensing authority to determine whether the drug is safe and effective to be made readily available to the public. Information relating to what the drug is made up of, the testing results and other factors will all need to be presented to allow the relevant authority to approve and allow the drug to be released.
Licensing differs in each country, each country’s government and health authority will have different requirements and procedures which a drug company has to follow and measure up to. If a company wishes to market their drug in different countries they then have to go through this whole process again, unless they apply for a European license which can help get the drug approved for a larger number of countries at once. This may not always be the case though as some countries will want additional information or further testing before they approve it for release in their own country.
Pharmalicensing isn’t black and white either, sometimes licensing authorities will approve a drug for release in a particular country but with certain provisos such as the drug only being available for certain age groups or strains of the disease. As there are many different factors that could contribute towards the effects of the drug in that one country it is sometimes the case that drug companies will have to go back to the drawing board for some countries and it isn’t uncommon for them to have to produce two or more variants of their drug based on this.
When it comes to pharmalicensing companies will spend a large chunk of time on ensuring their drug’s abilities and background are 100% clear to the licensing board, not only to make sure it is clear to see that the drug is in fact safe but also to help speed the process up as there will be less need for additional testing to be carried out and slow the time taken to get the drug on the market and available to patients that desperately need them.
Pharmaceutical drug development can be helped along with the help of additional research and resources that make it quicker to find the right cure.
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