Knowing the regulatory environment in Europe is important given how many consumers live in the European Union.
The European Union has grown over the past twenty years, and it currently has twenty-eight countries as members.
The regulatory laws of these members are governed by the European Medicines Agency (formerly known as the European Medicines Evaluation Agency). The European Medicines Agency has a structure somewhat different to the Food and Drug Administration.
The European Medicines Agency has a subdivision called Committee for Medicinal Products for Human Use. This committee is responsible for scientifically evaluating the drugs that are submitted for approval. In the basis of this evaluation, the European Medicines Agency will provide a recommendation to the European Commission regarding whether to approve the product.
Approval Processes in the European Union
There are three processes that can be used to attain approval for a drug in the European Union. The first is to obtain approval directly from the European Medicines Agency.
Several months beforehand, the manufacturer submits a letter of intent to the European Medicines Agency. In this letter, the manufacturer designates two representatives from the Committee for Human Medicinal Products.
These representatives are called the Rapporteur and Co-Rapporteur. These representatives will review the data and relay their assessment to the Committee for Human Medicinal Products, which will then relay it to the European Medicines Agency.
If the review is favorable, the European Medicines Agency will request that the European Commission's Enterprise Directorate-General approve the product. This process is required for all biotechnological products, orphan drugs, and drugs with new active ingredients that have a specific therapeutic indication, such as those for acquired immunodeficiency syndrome or diabetes mellitus. It is optional for other products.
The second process is to apply for drug approval in a number of selected member countries on the basis of a prior approval in a reference country.
The member countries have ninety days to determine whether they recognize the reference country’s authorization. If they decide to recognize the reference country’s authorization, a national marketing authorization will be issued for each country within thirty days. If one of the member states refuses to authorize a product on the basis of health and safety, the issue will be referred to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human.
The member countries of this group will try to reach an agreement within sixty days. If they cannot reach an agreement, Committee for Medicinal Products for Human Use may be called upon to arbitrate.
The Committee for Medicinal Products for Human Use will make a decision and inform the European Medicines Agency. The European Medicines Agency will send their decision to the European Commission's Enterprise Directorate-General. This mutual recognition process is applicable to most pharmaceuticals.
The third process is to apply for simultaneous authorization in multiple countries. The applicant may ask one of the countries to act as a reference country. After all the applications have been submitted, the reference country has seventy days to reach a preliminary decision.
The reference country will then forward a preliminary assessment on the application to the other countries to which an application has been submitted and to the applicant. The reference country will ask the other countries to give comments on the proposed authorization and return it. After one hundred-five days have passed, the reference country will send these comments to the applicant and may halt the application process if they need a response.
If a response is not necessary, the other countries have ninety days to approve the draft assessment report. Once they approve the report, the reference country and the other countries have thirty days to reach a final agreement. National marketing authorizations will then be issued in all applicable countries.This process is mostly used when a drug has not been previously marketed in any of the member countries.
Issues That May Arise
Manufacturers should be aware of some key differences between the Food and Drug Administration’s approval process and the European Medicines Agency’s approval process.
One difference that can affect approval is a difference in the structure of the European Medicines Agency compared with the Food and Drug Administration.
For instance, the Food and Drug Administration is responsible for both scientifically reviewing the application and making decisions as to whether to approve the drug. However, the European Medicines Agency is only responsible for approving the application and defers the scientific review to Committee for Medicinal Products for Human Use.
They then make a recommendation to the European Committee as to whether to approve the drug.
As such, the Food and Drug Administration tends to approve drugs faster than the European Medicines Agency does.
Thus medications tend to be marketed in the United States sooner than in the European Union. When a manufacturer uses either the mutual recognition process or seeks simultaneous authorization in multiple countries, the manufacturer should also be aware the application may have to go through several local agencies, because each country has a different approval process.
Manufacturers should be aware of the policies in the applicable countries. Understanding these issues will help manufacturers expedite the approval process for their products in the European market.