Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparative review of prescription drug labeling requirements across various regions and considerations for managing Company Core Data Sheet

Dr. Qiaoqian Luethi-Peng (Abschlußjahr: 2011)

Language: English

Availability of product labeling, also regarded as product information, for medicinal products is a regulatory requirement in all countries. Product labeling comprises of types of documents such as prescribing information, patient information leaflet which is derived from the prescribing information. Product labeling provides information about a products intended use, its expected benefits and potential risks to the users (e.g. healthcare professionals, caregivers and patients).

Product prescribing information requires approval from the appropriate National Competent Authority (NCA) before the medicinal product can be placed on the market. The approved product prescribing information forms the basis for product safety surveillance, serves as the prime reference for patient information and for the control of promotional activities.

Country specific regulations may lead to the fact that the NCA approved product labeling potentially varies from country to country. The differences can be expected in the product labeling concerning the effective (therapeutic indication and dosing) and safe (contraindications, warning and precaution for use, adverse drug reactions) use of a medicinal product for the intended use (therapeutic indication).

The Company Core Data Sheet (CCDS) concept has increasingly become the approach to strive for harmonized product labeling across countries, where CCDS is used as a vehicle to ensure consistent information regarding effective and safe use of a medicinal product be included in the local prescribing information.

In contrast to the product labeling approved by individual NCAs and valid in a given country/region, a CCDS is an internal reference document prepared by the pharmaceutical company. It displays the companys up-to-date position on essential characteristics of the product, while complying with recognized scientific standards as well as with applicable laws, regulations and regulatory requirements.

This master thesis is intended to provide a comparative review of regulatory requirements in major countries for product labeling of prescription drugs used in human, with focus on the sections concerning effective and safe use. The selection of the countries or region (Australia, Canada, European Union, Japan, Switzerland and United States of America) takes into consideration of the potential regional or global impact. The thesis attempts also to provide points to consider and best practice for companies to prepare and maintain CCDS.

In summary, as there are no international standards valid for all countries concerning the format and content of product labeling, the status-quo that the NCA approved product labeling potentially varies from country to country will remain. A regulatory compliant, data-driven and up-to-date CCDS, as a vehicle, plays a key role in ensuring the effective and safe use of a medicinal product, in ensuring timely and appropriate labeling for patient safety, as well as in reducing product labeling related litigation or reputational risks by efforts in the avoidance of unjustified local product labeling deviations across countries.

Pages: 76