Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The regulatory environment and requirements for biological and biotechnology-derived medicinal products in Japan

Renzo Wolbold (Abschlußjahr: 2006)

Language: English

Japan is one of the world´s largest pharmaceutical markets. Being a highly developed country with a population of roughly 130 millions and a population age structure with a high and increasing proportion of elderly people, Japan continues to be one of the very important regions for the large global players and international companies in the pharmaceutical industry with respect to sales opportunities as well as drug development and regulatory requirements, second only to the United States.

Medicinal products developed and manufactured on the basis of biological source materials have always been subject to distinct problems and challenges concerning their quality, efficacy and safety because of the underlying natural variability in content and quality of pharmacologically active substances and contaminations in the source materials and are therefore often regulated using stricter or additional regulatory guidance and legislation. In addition, recent scientific advance and developments in the area of biotechnology and life sciences have brought about tremendous possibilities to invent, develop and market medicinal products with potent drug substances possessing highly specific modes of action and pharmacological effects or interfering with complex biological regulatory networks but also with previously unknown and/or severe potential problems and dangers from the standpoint of drug safety inherent due to the very nature or manufacturing processes of these new drugs.
The Japanese pharmaceutical and healthcare industry as well as regulatory and administrative institutions recognize and prepare for the current and growing importance and success of biological and biotechnology-derived medicinal products in the pharmaceutical market and specific legislation and guidance for those products as well as for advanced therapy and cell- and tissue-based medicinal products has been and will be prepared and issued by the organisations responsible in order to cope with the new opportunities and dangers. In particular, the latest revision of Japan´s Pharmaceutical Affairs Law introduced additional measures to strengthen the safety of medicinal products manufactured from source materials of biological origin.

Japan´s pharmaceutical market and regulatory system has often been perceived as an exceedingly complicated system lacking transparency and was at times even described as a “mysterious and incomprehensible maze” [1]. This lack of accessibility is based on several factors some of which are rather objective and hard, e.g. a complex regulatory legislation and practice due to the history and evolution of the related laws and involved institutions and a lack of timely available and well translated important legislation and guidance documents, while others are more subjective and soft, e.g. socio-cultural differences between Japan and the Western world including the particular Japanese way of thinking and acting and a differing perception of the relationship between governmental authorities and industrial companies or of the healthcare professional-to-patient relationship in Japan.

To increase the mutual accessibility to the respective pharmaceutical markets with the aim of a faster access of Japanese patients to newly developed advanced medicinal products developed by foreign pharmaceutical manufacturers as well as an easier access to non-Japanese pharmaceutical markets for medicinal products developed by Japanese pharmaceutical companies, considerable efforts have been made from within and outside of Japan during the last decade in order to reduce the regulatory effort and burden necessary for the development, authorisation and marketing of pharmaceutical products for the involved parties and to further and achieve harmonisation of the regulatory requirements with the other two regions, the European Community and the United States, e.g. through the ICH process.
Although the harmonisation efforts were successful in many respects they have also brought about many new challenges for the involved parties mainly due to the fast pace of the recent evolution of regulatory legislation, guidance and institutions. In addition, differences regarding basic definitions of pharmaceutical regulatory terms and thus applicability of the respective laws and guidance as well as regulatory procedures still persist keeping the challenge of developing and marketing medicinal products in Japan alive.

This thesis gives an overview of the regulatory environment and requirements for biological and biotechnology-derived products in Japan with a focus on the regulatory authorities and institutions involved and the pharmaceutical legislation and regulatory guidance documents relevant and applicable for biological and biotechnology-derived medicinal products. Special emphasis is put on the recent developments and changes connected with the latest revision of the Pharmaceutical Affairs Law of Japan.

Pages 47,
Annexes: 10