Guidelines for Medical Writers: recent news from the European Agency for the Evaluation of Medicinal Products (EMEA)

By Alison Rapley

Those amongst you who regularly write documents for regulatory submissions will need no introduction to the invaluable list of EMEA guidelines available at http://www.eudra.org. They cover a very wide area and can also provide useful information to those writers outside the regulatory scene, particularly if you need to discover what is accepted practice in an unknown area. These guidelines are now available at the new EMEA web site, http://www.emea.eu.int. This article reviews the latest guidelines released by the EMEA. It is not a comprehensive list of new guidelines, but a review of those considered most useful to medical writers. You can access the full text of all the guidelines at the new EMEA site. This site will replace the old EUDRA site, and new guidelines will be available only at the EMEA site. They can be found at “Human Medicines/Regulatory Guidance and Procedures/Notes for Guidance”, and are arranged into files on blood products, biotechnology, efficacy, general guidance, herbal medicines, ICH, orphan medicinal products, pharmacovigilance, quality, and safety. "Concept Papers" and "Points to Consider" provide preliminary guidance before release of a full guideline. If you are interested in peripheral arterial occlusive disease, epilepsy, irritable bowel syndrome or diagnostic agents you should check out the following. They give background information on the disease and incidence as well as providing guidance on the recommended drug development programme, including the type of trials that should be carried out, patient population, trial design, recommended efficacy and safety assessments, and type of analysis. Note for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Epileptic Disorders (CPMP/EWP/566/98) Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (CPMP/EWP/714/98 DRAFT) Concept Paper on the Development of a CPMP Points to Consider on the Evaluation of Drugs for the Treatment of Irritable BowelSyndrome (CPMP/EWP/785/97) Points to Consider on the Evaluation of Diagnostic Agents (CPMP/EWP/1119/98) The guidance on bioavailability and bioequivalence studies is essential reading for those of you involved with generic compounds. It provides a clear definition of the two terms and explains how these studies should be conducted and analysed, and the acceptance criteria for the pharmacokinetic parameters tested: Note for Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP/EWP/QWP/1401/98 DRAFT). There are also new safety guidelines relating to safety pharmacology studies and non-clinical local tolerance testing. Note for Guidance on Safety Pharmacology Studies for Human Pharmaceuticals (CPMP/ICH/539/00 ICH Topic 57A) discusses what safety pharmacology studies are, why they are needed and how they should be designed. It provides a useful overview of such pharmacology studies. Note for Guidance on Non-clinical Local Tolerance Testing of Medicinal Products (CPMP/SWP/2145/00) covers the design of local tolerance tests and the type and extent of testing required, with specific information for the ocular, dermal, parenteral, rectal and vaginal routes of administration. New quality guidelines cover metered dose inhalation products, herbal drugs and even the grade of pharmaceutical water to be used! These quality guidelines relate to the methods of preparation and stability and, as such, are probably less relevant to medical writers in general. Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products (CPMP/QWP/2845/00 DRAFT) Note for Guidance on Specifications:Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products (CPMP/QWP/2820/00 DRAFT) Concept Paper on the Development of a CPMP/CVMP Note for Guidance on the Quality of Water for Pharmaceutical Use (CPMP/QWP/1676/00 DRAFT) The guidance paper on tradenames has also been revised. This details situations where a proposed tradename may be refused for reasons of confusion with an existing product or misleading therapeutic or pharmaceutical connotations. Revised Guidance Paper on the Acceptability of Tradenames for Human Medicinal Products Processed through the Centralised Procedure (CPMP/328/98 rev. 2 DRAFT) For those of you involved in producing regulatory documents, the ICH guideline on the common technical document gives an idea of how things will be organised in the future: Common Technical Document for the Registration of Pharmaceuticals for Human Use: Organisation of Common Technical Document (CPMP/ICH/2887/99 ICH Topic 4) The majority of these guidelines are written in a clear, easy to understand way - perhaps they have employed a few medical writers! They can provide a good overview of a particular therapeutic area or type of study. There is also a lot of other useful stuff on this web site, but that’s another article, for another issue of TWS - any volunteers? Alison Rapley PAREXEL INTERNATIONAL, 50 Occam Rd Guildford, Surrey GU14 8LU, UK Tel (+44) 1483 255117 alison.rapley@parexel.com