Future perspectives of regulations — harmonization of data requirements

Autor:	B. A. Gennery
Rok vydání:	1989
Předmět:	Documentation Risk analysis (engineering) Order (exchange) Control (management) Member state Legislature Harmonization Business Marketing authorization
Zdroj:	International Medicines Regulations ISBN: 9789401068734
DOI:	10.1007/978-94-009-0857-4_22
Popis:	1. Current EEC Directives provide good general guidance on the format of documentation while specific Directives aid the planning of drag development programmes. 2. The conditions under which clinical research programmes can be started still vary considerably and require harmonization. 3. To aid harmonization scientific issues must be separated from economic ones. 3. Adverse event reporting for products already on the market still lacks uniformity. 3. The highly complex area of biotechnology products is changing rapidly and requires careful attention in order to avoid unnecessary obstruction through legislative control.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::c7ea89b5cb25416766de9bc18323fe55 https://doi.org/10.1007/978-94-009-0857-4_22 Zobrazit plný text záznamu