Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Intelligence in the Development of OTC Products ***

Kolmal Musa (Abschlußjahr: 2014)

Summary
Language: English
The process by which a prescription medication moves from prescription to over-the-counter (OTC) status for either the same or a related use is called Rx-to-OTC switch.
The reclassification of a drug and / or the associated indication (s) of Rx OTC status presents, in general, a scientific data-driven and highly regulated process.
OTC medicines are strictly regulated and a number of regulatory processes have meanwhile been developed to allow for new and approved products to be reviewed and approved in a clear and transparent manner. For a medicinal product to be issued OTC status, it must possess both a proven adequate safety margin and corresponding effectiveness. Consumer friendly and understandable labeling to ensure self-diagnostic in the absence of medical guidance must be secured.
The pharmaceutical industry is facing many challenges such as rising drug development costs, increased competition and shorter periods of market exclusivity to maximize their return on investment (ROI). Therefore, life cycle management strategies must be re-examined and established through the pharmaceutical industry in order to proactively overcome these challenges and optimize revenue stream. Product life cycle management (PLM) can encompass many ways including reformulations, advanced delivery formulations, expanded indications, fixed dose combinations as well as the assessment of opportunities to switch Rx drugs to OTC or develop pre-authorized or branded generics.
However, one of the alternatives to extend brand life cycle of a Medicinal Product (MP) is to develop a switch strategy of the MP from Rx-to-OTC. The timing of Rx-to-OTC switching will depend on many external factors: These include patent expiration and generic erosion of the parent compound, new Rx technologies to optimize delivery and line-extensions as well as the OTC competitive environment and product labeling.
Depending on the regulatory switch strategy chosen the process can result in a successful switch, it might take several months or years. But it might also completely fail. To be considered, different types of Procedures result in the development of various strategies!
However, developing a switch strategy should be based on regulatory data to support the switch process. Regulatory Intelligence (RI) data sources play a crucial role throughout the whole life cycle of a medicinal product with regard to procedural, technical, scientific and strategic input. This key role includes general data gathering and tracking legislation, followed by information dissemination and utilization. Therefore, the use of all possible available sources for Monitoring of Regulatory environment such as Guidelines and Directives and the legal requirements as well as all other publicly available regulatory data at both national and international level is of importance in order to achieve a successful European and global business.
In the context of Regulatory Intelligence in the development of OTC product strategy the sources mentioned previously in section 4 should be well monitored, implemented and applied. Since the Regulatory framework covers all phases of the product life cycle and considered to be the key success driver, RI sources remain as the most important business success factor (e. g. Switch Guidelines: Classification Guidelines; “Guideline on Legal Status for the Supply to the Patient of Centrally Approved Medicinal Products” etc.).
In order to develop a switch strategy there are some issues that need to be verified in advance. These include among others selecting the type of procedure (CP/MRP/DCP NP), Competitor Analysis and applying the assessment framework. Different types of Procedures result in the development of different strategies.
Data transparency plays a key role in facilitating the tracking and monitoring of regulatory data besides competitive/competitor strategies to complete the planning of a regulatory strategy. Publicly available information sources became more valuable through strong transparence of available databases such as the EMA- new database “Eudra Vigilance Medicinal Product Database Extended (EVMPD)” on EU-level as well as on national level e.g. the German new AMANDA-database.
The target subject of this master thesis is to present a general overview about possible approaches based on possible regulatory intelligence sources, for developing a successful switch strategy of the legal basis of medicinal product that has been recognized as a potential switch candidate in respect to similarities, despite differences and challenges within the European Union. Through the three mentioned study cases it has been confirmed that selecting of the right regulatory pathway is an important strategic factor in order to achieve the success. Good knowledge in regulatory framework including Directives, Guidelines, and amendments, as well as competitor’s strategies, are considered to be essential as they play a decisive role in taking decisions regarding business strategy.
Pages: 61