< previous page	page_440	next page >
Page 440 Table 3 Factors Influencing Choice of Procedure Type of Product Biotechnology Centralized NASa/High Tech Decentralized or centralized Others Decentralized Does it classify as ''High Technology''? Previous submissions on same product if it is a line extension Previous submissions by other companies in same therapeutic area Performance of Procedures Marketing needs (e.g., marketing foreseen in all of Europe or only selected countries) Involvement with other companies (codevelopment, comarketing) Medical practice differences? Acceptance of indications in all countries? Internal work load / allocation of dossiers between procedures Implication of protection from second applicant aNew Active Substance. be published by the Agency but probably with some delay so it will be essential for each company to have its own network of information from colleagues. Once the dossier is filed it will go through a check in process to ensure completeness. This is not as detailed as the Refusal to File process in the FDA but nevertheless incomplete applications will not be accepted into the process for evaluation. During the evaluation process questions should arrive at the company in a more coordinated, concentrated fashion than now and there will be defined time frames for answering these. It will be important therefore that possible queries have been identified beforehand and some pre- Table 4 Factors Influencing Choice of Originating Member State Experienced Health Authority as first country Health Authority experienced with indication Opinion leaders present in the country Clinical trials conducted in the country Time to approval Good appeal system Possibility of presubmission dialogue and good liaison during the procedure Experience of Drug Regulatory Affairs Department in the subsidiary Pricing and other marketing considerations Obtaining good quality postmarketing information quickly.
< previous page	page_440	next page >