New Drug Application in Europe
Do you think that getting approval for a new drug in the US is a real pain? Try your luck in Europe. One may wonder how it can be so different on the two sides of the Atlantic after the guidelines for Common Technical Document (CTD) were set in place. Well, we shouldn’t forget that the US is a single country while Europe is a whole continent. Below is a very brief overview of the procedures a new drug applicant has t
o go through to break into the European market.
The European Medicines Agency (EMEA) is the EU counterpart of the US FDA as the main regulatory institution. In addition, each member state has its own regulatory board. We are talking here about 27 member states and 3 EFTA countries, making it 30 countries in total. There are three procedures to get a drug approved in Europe and there are strict guidelines as to which products should follow which procedure.
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The Centralised Procedure is obligatory for products which include among others, drugs against HIV and cancer and products derived by recombinant DNA and monoclonal antibody technologies. In 2008, some more products will be obliged to follow this procedure. The end result of this procedure is a single marketing authorisation and a single trade name for all 30 countries.
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The Decentralised Procedure (DCP) is for products not qualified for the centralised procedure and have not received a marketing authorisation in any of the EU/EFTA countries. It involves parallel submissions to the member states chosen by the applicant. The end results are several marketing authorisations and different trade names.
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The Mutual Recognition Procedure (MRP) is for products which have already been granted a marketing authorisation from an EU/EFTA country. If the applicant wants to expand this authorisation to other countries, then this is the way to go. The end results are similar to those of the DCP.
Take note that for both DCP and MRP, the submission dossier should be translated into the official languages of the countries in question.But don’t worry. Complicated as they may be, all submission procedures actually follow well-defined steps and strict timelines. And - they work!!!
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