Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory considerations, opportunities and challenges for pharmaceutical companies in developing a multi-vitamin/mineral product ***

Michael Kravzow (Abschlußjahr: 2018)

Summary:
Language: English
Text of the abstract: The global sales of consumer healthcare products were estimated to US$217 billion in retail value in 2016. The business is divided in different product categories. One of the largest categories is the Vitamins, Minerals & Supplements (VMS) which represents products that may contain vitamins, minerals, botanical or herbal ingredients, amino acids, enzymes, among other substances. People use VMS products for e.g. maintaining their general health, to support mental and sports-related performance, and to provide immune system support. An important sub-segment in the VMS category is Multivitamin/Mineral (MVM) products. They contain a combination of vitamins and minerals, and sometimes other ingredients as well. Some of the biggest MVM brands are marked by pharmaceutical companies like Centrum® by Pfizer, Berroca® and Supradyn® by Bayer.
MVM products can be legally classified either as medicinal products (OTC) or as food supplements depending on their nature, composition, properties, intended use and presentation. For pharmaceutical companies, the marketing of MVM products under the regulatory framework of food supplement in the European Union (EU) has some advantages like shorter time-to-market or less time and cost intensive maintenance work compared with the requirements set for medicinal products. This opportunity might complement the product portfolio for a pharmaceutical company in their consumer healthcare business and contributes for further growth.
However, the development of a MVM product is not trivial. This is on the one hand due to the complex nature of vitamins/minerals, their sources and other substances used. Vitamins tend to react with e.g. other vitamins and/or minerals under certain conditions and differently depending on the dosage form, and the stability behavior of vitamins/minerals are different and difficult to predict. On the other hand, non - EU harmonised measures for food supplements like minimum and maximum dosage amounts of vitamins and minerals, their purity criteria and the use of other substances need to be taken into consideration.
The present work describes the challenges pharmaceutical companies may face in developing, controlling and marketing of MVM products and to compare the regulatory frameworks which need to be considered, when the product is placed on the market either as a medicinal product (OTC) or as a food supplement in the European Union (EU). It focuses on the product development and quality standards mainly under the EU and Community legislations. It shows that the regulatory framework for food/food supplements is similar complex but different compared to the regulatory framework for medicinal products. Therefore, it is important to understand that medicinal product legislations cannot be automatically applied to MVM products under the legal scope of food supplements and the knowledge and implementation of food/food supplement legislations are a prerequisite in the development, production and marketing of food supplements in the EU.
Pages: 63