Medical Products Approval Processes. Why Does It Take So Long?

This article takes a quick look at the long process that all medical products have to undergo before being approved for consumer use.

There are hundreds and thousands of medical products currently on sale to the UK public, doctors and hospitals around the country. Each and every single one of these products has undergone and extensive and lengthy process to ensure that they are all user safe and effective. This article takes a quick look at the long process that medical products have to go through before being deemed medically safe and effective.

First of all, we need to know who is responsible for validating the safety of all proposed new drugs. In the UK, the authority in charge of this sort of thing is called the Medicines and Healthcare products Regulatory Agency (MHRA). They are in charge of testing and approving medical product sales for use throughout the UK, however, if you wish to market your product to the rest of Europe as well, you will need to have it approved by the European Medicines Evaluation Agency (EMEA) who are in charge of all European medical products. In general, most pharmaceutical companies will want their products available to the much larger European public and would therefore register with the EMEA.

Three primary committees make up the EMEA and between them they figure out which medical product developments are approved or not. The three committees are as follows:

  1. Committee for Proprietary Medicinal Products (CPMP) who are responsible for medicines for human use.
  2. The Committee for Veterinary Medicinal Products (CVMP) who are responsible for the medicines for veterinary use.
  3. The Committee for Orphan Medicinal Products (COMP) who are responsible for ‘orphan medicines’ for rare diseases.

When applying for a license from the EMEA, there are two ways in which your product may be approved. The first is called the Centralised System, and the second is appropriately named the Decentralised System.

The Centralized system if used for the approval of drugs that will be used in relation to Aids, Breast Cancer, Neurologic diseases such as autism and others such as diabetes. Once a license application has been received, it is handed over to the CPMP who have to analyze test results, the use of the drug and the relevance and importance of it to the medical industry. Whether or not the drug is of a suitable and ethical nature or not is decided by this committee. Once all information has been researched in great depth, they then have the authority to decide whether or not to approve the medical product.

The Decentralised system which is also known as the Mutual Recognition System which involves having the drug assessed by one of the member states before the application is sent to the remaining states for approval based on the original state’s recommendation. Only once ALL member states have unanimously agreed that the product is to be approved, will it be made officially available for public use.

The above steps may seem simple, but there are so many process involved before any innovative medical product is ready for approval. The average timeline for the approval of drugs from conception to completion is about 8 years. The clinical testing of the products (which takes place before an application to the above committees) takes the longest as all avenues of safety and effectiveness have to be tested and optimized.

There are processes in place should an emergency medial product be required for use ASAP, such as was the case with the recent outbreak of Swine Flu. Extensive priority get’s placed upon these drugs to make them available as soon as possible, however there is always an element of risk involved when rushing approval.

The fact is, it may take a long time for new medical products to be approved, but it’s for our own good as consumers that all drugs are extensively tested. One small slip-up could result in disastrous consequences for consumers. So my advice, take it easy on the Medical Boards and appreciate that they have your safety as their highest priority.