Masterarbeit

Global Regulatory Registration Plan for a Fixed-dose Combination in the Indication of Hypertension in the European Union, the Unite States of America and selected Emerging Markets ***

Dr. Silvia Specker (2014)

Summary
Arterial hypertension is a frequent disease seen over the entire world and a key risk factor for cardiovascular diseases and stroke. Often monotherapy of different antihypertensive drugs cannot address the multifactorial disease and thus does not lead to sufficient lowering of the blood pressure. The combination of drug substances, especially as fixed dose combinations is an important contribution to the different treatment regimens for arterial hypertension. Fixed dose combinations can simplify the medication regimen and potentially improve compliance.
An invented case scenario for the therapy of essential hypertension with a fixed dose combination (FDC) of amlodipine and a new active pharmaceutical ingredient from the therapeutic class of the sartans was chosen to establish an example. The registration is planned in the following countries: All 28 European Union countries, United States, Australia, Brazil, China, India, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan, Thailand, and Turkey. The project is currently at the end of the clinical phase 2.
Such a registration of a medicinal product in the European Union, the USA and important emerging markets requires a precise regulatory development strategy and planning. In this thesis a regulatory development and submission plan is outlined. The focus of this work is on the specific guidelines for fixed dose combinations and the guidelines in the indication of hypertension in the targeted countries. This thesis comprises the clinical phase 3 program and the required local clinical data as well as the paediatric development plan in the European Union. The competitor analysis and sources of standard therapy information emphasizes a central element for the development of a new medicinal product. The registration timelines in the non-ICH countries depend mainly on the time when the following requirements are fulfilled: Reference approval in a recognized country, availability of global and local clinical data, specific stability requirements, GMP inspection, and registration sample availability. In the last part of this work, the regulatory risk assessment and possible risk mitigation measures are discussed.
Pages: 44, Annexes: pages: 10