The European Community has long been concerned with the issue of creating a policy for the control of drugs, that adequately reflects the reality of the economic and political integration process. Accordingly, it has been concerned with creating a common political ground for the control of drugs; it has issued a series of directives to harmonize the procedures of drugs approval, and others which seek to standardize some very specific principles for drug use. But perhaps the most significant progress has been the setting up of common «supranational» institutions for the control of drugs, in particular the European Agency for the Evaluation of Drugs and the Committee of Pharmaceutical Products.
The establishment of these common and stable organizational institutions, allows to have analysis and decision-making bodies with resolutive capacity and direct communication channels with the highest decision-making levels of political power in the Community.
• Mutual acceptance of National Regulatory Authorities: The Community has made significant progress in the coordination of Approval procedures. In brief, we could say that the applicant goes to the country's authorities to apply for regulatory approval; the applicant presents the required documentation and notifies the other countries where he also wishes to obtain approval. The authorities of the first country study the application, make a decision and notify their decision to the interested party and to the other countries; in turn, these would evaluate the application based on the study conducted by the first country, and make a pronouncement in a brief and previously established period of time. If the applicant does not agree with the decision made by the first country, he may appeal to other instances, such as the Committee and the Agency, which will study the case and decide on the agreement procedure to be followed.
This avoids the duplication of efforts resulting from the various national (non communitary) schemes for pre-marketing evaluation of products, and also enables the concentration of technical resources.
• Approval of similar drugs: Progress has also been made to simplify the approval of similar products, which facilitates a better supply to the market and avoids complex evaluations for products already known and evaluated.