Masterarbeit

Management of Worldwide Regional Regulatory CMC Requirements - An Approach by Creation of a CMC Database

Diana Jung (2014)

Summary:
Language: English
The pharmaceutical industry is one of the most highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public. Although worldwide regulators share the same goal, to ensure the quality, safety and efficacy of approved drugs, there is no unified approach for drug approval requirements. Regulatory requirements vary from country to country.
The pharmaceutical market covers more than 100 countries. The market can be divided, based on its regulatory diversity into the regulated and the emerging markets, the latter covers regional worldwide countries. Regulatory diversity is tremendous when comparing individual country requirements and it has become extremely complex to fulfill each country’s specific requirements. Having knowledge of the guidelines is a pre-requisite and basic tool for successful submissions.
Most international companies analyze the differences and similarities between the regulatory requirements and pharmaceutical legislations of regional countries to develop regulatory strategies in order to avoid submission surprises. However, in many international companies there is no robust process in place and heterogeneous approaches for regional submissions exist, e. g. what to be provided with the initial submission package. This not only consisting of the dossier but also including country specifics, the so called additional documents of proof such as declarations, certificates, raw data, or the like.
One of the major problems here is the management of the information overload and the establishment of a system from which the collected regulatory requirement information can be directly applied for successful submissions. Thereby, resulting in a scenario that proactive regional country specifics are assured.
The following thesis presents a proactive approach to understand regional requirements by the collection of information via a ‘Regional Regulatory CMC Requirement’ database. It goes beyond a simple description of a software tool. It appraises the situation by assessing what information should be collected and why, the focus only on the ‘Chemical, Manufacturing & Control (CMC)’ landscape in regional worldwide countries. The thesis also reflects the limits of information, how it should be used, as well as providing a potential problem analysis aimed to improve the information content by verification and what processes are needed in addition.
Pages: 49