Have you ever wondered why it takes such a long time for any new medical products to become available to the public? Often we hear of drugs which could potentially save lives or cure serious illnesses, however doctors are unable to prescribe these drugs due to the fact that they are unlicensed. This article takes a look at the regulatory affairs involved in licensing a drug for legal use in the UK and the rest of Europe.
Who is responsible for licensing innovative Medical Products?
Depending on whether you’re simply licensing a drug for use in the UK or if you wish to market the drug to the entire European market, you will need to either register the new medical product with the Medicines and Healthcare products Regulatory Agency (MHRA), or the European Medicines Evaluation Agency (EMEA) respectively. Most companies will ensure that they register with the EMEA as the target market is much bigger and therefore health economics comes into play as even pharmaceutical companies want to be more profitable.
The EMEA is made up of three main committees, with each committee being represented by two representatives from each member state. The 3 committees are as follows:
- Committee for Proprietary Medicinal Products (CPMP) who are responsible for medicines for human use.
- The Committee for Veterinary Medicinal Products (CVMP) who are responsible for the medicines for veterinary use.
- The Committee for Orphan Medicinal Products (COMP) who are responsible for ‘orphan medicines’ for rare diseases.
How does the licensing process work?
When applying for a medical product sales license for the UK only, one would contact the MHRA with details of the license request. The MHRA will then hand the product over to the Committee on Safety of Medicines (CSM) who will do the necessary research and legal work to ensure that the product is suitable for the UK market.
When applying for a license from the EMEA, there are two main methods to approval of a new drug: The Centralised system and The Decentralised System.
The Centralised System is used for any drugs for AIDS, cancer, neuro-degenerative conditions or diabetes. The above-mentioned Committee for Proprietary Medicinal Products (CPMP) assesses the application thoroughly and have the authority to approve or disapprove the application.
The Decentralised System (aka mutual recognition) requires the medical product to be approved or denied by one of the member states within the relevant committee. In the UK, this would be done by the MHRA. If the member state committee approves the application, they then propose to the remaining member states to have the drug approved for use in the entire EU. Only once the drug has been unanimously accepted amongst all member states will it be made available for sale.
It’s not always the safety of a drug that can influence the decision on whether or not to make a drug available for marketing. A case study a few years ago spoke of a Medical Product Design company that applied for their latest product, an alleged hangover cure, to be made available to consumers. The CSM denied the application in the light that the drug was advocating the abuse of alcohol. The pharmaceutical company that created the drug had to re-evaluate their branding and marketing strategy to be in line with the CSM’s regulations before re-submitting their application.
How long does it take to approve drugs?
From the initial medical product development stages, until the drug is approved and available for sale to consumers, it can take a period of up to 8 years on average. This is an extremely grueling process in which the clinical testing phase of medical products takes the longest. However, once a drug has been submitted to one of the regulatory committees, it usually takes up to a year to be approved.
A recent article in the news suggested that there are processes in place to speed up the approval of emergency medical products that could bypass certain steps to be made available sooner in order to accommodate special cases where patients simply cannot wait years for approval.
Yes, drugs take a long time to be approved and sometimes we perhaps think that committees are being overly cautious when it comes to approving new drugs that could save thousands of lives. However, we need to be patient and understand that just one small mistake in this process could result in massive consequences for a lot of people worldwide. The UK is one of the world leaders in pharmaceutical innovation and we can be proud of the medical products that we have contributed to the industry.
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