Current guidelines applicable for the approval of topically applied dermatological drugs in the EU.
Dermatologicals as well as other medicinal products are submitted to the rules governing medicinal products in the European Union (EU) (Directive 2001/83/EC). With appreciation of the EU enlargement those regulatories deserve a recent consideration with special regard to the peculiarities of external dermatological therapy, recently passed novel and future guidelines. As regards the criteria for authorization of a medicinal product it is set out in Regulation (EEC) 2309/93 Article 11(1) that a marketing authorization shall be refused if it appears that the quality, the safety or efficacy of the medicinal product have not been adequately or sufficiently demonstrated by the applicant. Article 26(1) of Council Directive 2001/83/EC is worded a little differently but the criteria are the same irrespective of the procedure for the marketing authorization. For the final evaluation of the benefit/risk profile of a topically applied dermatological medicinal product not only the active agent but the whole galenic formulation as well has to be taken into account as the extent of penetration of the active compound might be influenced by changing the non-active substances. Furthermore the vehicle itself - independent of the active agent - influence the dermatological disorder, often in dependence on the stage of the dermatopathy. With special concern to safety/tolerability the (photo)toxic and (photo)allergic potential of the dermatological drug have to be taken into consideration too. In case of total body therapy in children the differing percutaneous resorption due to another body surface/body weight relation deserves special concern. The following review gives a survey of the current most important EU-guidelines for the evaluation of the benefit/risk profile of topically applied dermatological medicinal drugs and an outlook on further developments. As systemically applied dermatological medicinal products are assessed like other systemically applied drugs they are not treated in the following contribution.
Federal Institute for Drugs and Medical Devices, Bonn, Germany. straube@bfarm.edu
Myrjam Dorothea
MD
Straube
Achim
A
Zesch
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D002648:Child; D002986:Clinical Trials as Topic; D003879:Dermatologic Agents / Q000009:adverse effects / Q000592:standards / Q000627:therapeutic use*; D004338:Drug Combinations; D004348:Drug Labeling; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D011565:Psoriasis / Q000188:drug therapy
D000305:Adrenal Cortex Hormones; D003879:Dermatologic Agents; D004338:Drug Combinations