Safety assessment reevaluation of Biotechnology-Derived Pharmaceuticals as the imperative for getting renewed Marketing Authorisation Approval (MAA) Experience from Medicies and Medical Devices Agency of Serbia-Alims

摘要

According to DIRECTIVE 2001/83/EC and Amendment of the DIRECTIVE 2003/63/EC a biologicalmedicinal product is a product, the active substance of which is a biological substance. A biological substance isa substance that is produced by or extracted from a biological source and that needs for its characterisation andthe determination of its quality a combination of physicochemical-biological testing, together with theproduction process and its control. The following shall be considered as biological medicinal products:o immunological medicinal productso medicinal products derived from human blood and human plasmao medicinal products falling within the scope of Part A of the Annex to Regulation (EEC) No 2309/93;o advanced therapy medicinal products as defined in Part IV of this Annex.The complex structural and biological characteristics of biotechnologically derived pharmaceuticals,dictate that different approaches to their safety evaluation are needed.Initial MAA of Gardasil?- the HPV Vaccine (types 6,11,16 and 18) (recombinant, adsorbed), has beenperformed in Serbia on 2006.year.According to related EU guidelines, and Law on medicines and medical devices of Serbia("The Official Gazette of the Republic of Serbia", 30/2010), biologics license application implied evaluation theclinical, non-clinical, product, and manufacturing data, as well as review the pharmacovigilance plan anddetermines need for post-marketing studies.On November 2011.year, Expert of ALIMS gave the negative opinion related to 5 years duration ofrenewed MAA .