Drug safety regulations in the CPMP

Abstract

Regulation of drug safety (in the context of the overall assessment of Safety, Quality and Efficacy) is required by the Committee on Proprietary Medicinal Products (CPMP) to try to ensure that any medicinal product which is granted a Marketing Authorisation by any Member State of the EU has been adequately examined for possible adverse effects to patients or to the environment. Until the end of 1994, the actual granting of a licence to market a medicinal product was entirely under the control of individual EU Member States, but with the possibility to accept the opinion of the CPMP regarding the suitability, including safety, of a product to be a marketed medicine. In fact Member States have brought their domestic legislation into line with that of the European Commission, so that safety testing has been required to a common standard based on the EC Directives, Notices and Notes for Guidance that have been published from time to time over the last 30 years (see Appendix). From 1995 onwards, it has been possible for pharmaceutical companies to obtain a binding opinion from the CPMP, which will translate (for centralised applications) into a European Licence intended to be valid and identical in every Member State in terms of the Summary of Product Characteristics, which gives clinical indications, contra-indications, warnings, etc. The safety data needed to support the European Licence (Marketing Authorisation) is not very different from the previous requirements. Thus it remains necessary to produce convincing preclinical (non-clinical) and clinical safety information before an authorisation is agreed and to submit all relevant data on safety issues to the Regulatory Authorities after marketing in any part of the ED. In this way, the CPMP can act on behalf of the EU to ascertain whether sufficient work on safety aspects of drug development has been conducted Pre-licensing and whether prompt an effective monitoring of the Post-licensing situation is in place. Under this new centralised system (obligatory for biotechnological products and optional for new active substances or advances in technology) the CPMP appoints a Rapporteur from among its committee members to organise the assessment of the data submitted with a Marketing Authorisation Application. The CPMP will receive this assessment in the form of an Assessment Report (AR) which will be accepted, or modified in the light of further questions and answers, to generate the final AR the basis of the decision on whether to grant the Marketing Authorisation. Parts of this AR will relate to the safety of the product. To try to ensure that each assessment is universally comprehensible, a guidance document, addressed to the regulatory assessors, has been released. The guidance proposes a list of subjects that should be covered, the order in which they should be discussed and lists of issues that have been of frequent interest to regulators in the past. This presentation concentrates on the advice to regulatory assessors as to what they should look for in a submission and what quality they should expect from the safety data presented to support the application. The advice is a distillation from the Directives, Notices and Notes for Guidance already mentioned.