U.K. Applications Submitted to the CPMP

Abstract

Since the multistate procedure for obtaining marketing authorizations in the EEC was established there have been 38 such applications. All have been referred to the CPMP since there have been objections from one or more member states in every case. Of these 38 applications, IS have been forwarded from the UK. Although this represents 40% of the total and is greater than the experience of any other member state, it is still a small sample and caution is therefore required in interpreting the results. The products and recipient member states concerned with these outgoing UK applications are summarized. The dates on which applications were forwarded by the UK were not the starting dates for the “120 day clock.” There were often clerical or administrative difficulties in submitting the applications to different states. This was particularly noticeable for the first few applications but was later corrected. In all cases the CPMP opinion was delivered within the 60-day period permitted in the Directives. These 15 applications represent a large range of medicines: single new chemical entities (Benoxaprofen, Flenac), combination products (Prestim, SCH 286), and new formulations of established ingredients (Nicorette, Bidocyl). The fate of these applications in the CPMP is outlined. In only a few cases were there clear YES/NO opinions. Divided or qualified opinions occurred commonly. In nearly all cases there were reservations or requests for clarification on analytical issues or on the prescribing literature. Alone these were never sufficient to merit refusal of the application. The clear refusals (four in number) were based on major objections relating to safety and/or efficacy from several member states. Although the outcome at national level of several of the later applications is not yet decided, in those cases where qualified or divided CPMP opinions were given several member states have granted authorizations. It is clear that the grant of a UK license is not automatically recognized by other member states. The large number of minor objections on analytical or pharmaceutical points is not particularly worrying. These objections did not determine the fate of the applications and the recently established working party on pharmaceutical quality may make this even less of a problem in the future. The major objections on grounds of safety or efficacy pose a greater problem for harmonization. We all use the same guidelines yet different opinions are reached on the same preclinical or clinical data. The new multistate procedure that comes into operation later this year gives applicants the right to make representations to the CPMP. This may encourage member states to adopt a more harmonious approach to the data.