Just as America has the Food & Drug Administration agency to safeguard public health, Europe has its own equivalent, the European Medicines Agency (EMA), which is located in London. The EMA’s mission is essentially to make decisions based on evidence, to regulate the approval and marketing of medicines and to promote public health awareness. In this sense its remit is very similar to that of the FDA’s, and both exist to provide vital public safeguarding and knowledge building.
Like the FDA, the EMA reviews and decides whether to approve licensing for certain drugs in Europe, for both human and veterinary uses. It uses definition criteria broadly comparable in many ways to that of its counterpart over the pond.
When asking how long does it take to get a FDA 510k approved, the question is equally pertinent to the EMA – both organisations have a lengthy and stringent application process which can take significant amounts of time, especially where medical products need to be tested and approved.
The Applications Process
For this reason, many firms submitting applications for approvals will use specialist companies to support the process. This speeds it up where possible, with specialists such as www.fdathirdpartyreview.com providing the best quality information in a timely manner and utilising their knowledge of the process intricacies. A dossier is required to get marketing authorisation, which must demonstrate evidential data of the product’s safety, quality and effectiveness.
The EMA’s process has also been streamlined, cutting the original 15 regulation authorities in the EU down to one and moving to just two systems of authorisation – national and EU. Companies can choose to apply for approval to market in one member country or across the EU, often via a mutual recognition agreement. The EMA manages the new and centralised process, which is eligible for innovative and primarily high tech products such as those in the biotech industries.
Where differences do exist, there is nevertheless the same goal – making sure safe, quality and effective drugs are available to people and for animal use, promoting public health, ensuring responsible advertising of products such as tobacco and sharing information where appropriate and possible. This is particularly important because failures of compliance or issues with rogue products risk becoming a problem in the broader global marketplace.