Thinking Globally: Product Development, Registration, and Marketing in the New Millenium
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0092-8615/99 Copyright 0 1999 Drug
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THINKING GLOBALLY PRODUCT DEVELOPMENT, REGISTRATION, AND MARKETING IN THE NEW MILLENIUM KEIGO DANJOH Senior Adviser, International Affairs, The Proprietary Association of Japan,Tokyo, Japan
This paper covers the regulatory environment in Japan. The “Basic Policies for Approval to Manufacture Drugs”adopted by the Ministry of Health and Welfare in 1967 is described in detail. Pharmaceutical retail outlets in Japan are explained. Topics of interest: prescription to over-the-counter switches, Kampo or Chinese medicines, and consumer attitudes toward nonprescription medicines are covered. Key Words: Japan; Ministry of Health and Welfare; Prescription drugs; Over-the-counter drugs; Kampo or Chinese medicines
TWO MAJOR TRAGIC EVENTS, Thalidomide in 1961 and cold remedies in ampoules which caused several deaths in 1965, triggered the development of “Basic Policies for Approval to Manufacture Drugs” by the Japanese Ministry of Health and Welfare in October 1967. For the first time in the long history of pharmaceuticals in Japan, this document drew a clear distinction between prescription and nonprescription medicines. In the wake of the controversy over these severe adverse drug reactions, the Ministry of Health and Welfare attempted to establish a regulatory climate of conservative and stringent control over medicines, especially nonprescription medicines. In this context, “Basic Policies for Approval to Manufacture Drugs” demonstrated three basic concepts:
1. Classification of medicines, 2. A “dual” product registration system, and 3. A “you are no better” philosophy.
BASIC CONCEPT #1: CLASSIFICATION OF MEDICINES All prescription medicines fall under the drug tariff and are subject to reimbursement under the health insurance reimbursement system. Nonprescription medicines are not subject to reimbursement.
BASIC CONCEPT #2: A “DUAL” PRODUCT REGISTRATION SYSTEM
The registration system consists of two elements: approval and license. Approval is an official confirmation that the drug is both safe and effective. This is granted to a product and to an applicant. License is permission to do business, eiPresented at the DIA 34th Annual Meeting “Thinking Globally: Product Development, Registration, and Mar- ther manufacturing or importing a drug for keting in the New Millennium,” June 7-1 l , 1998, Bos- which approval has already been granted.The ton, Massachusetts. applicant must satisfy both personal requireReprint address: Keigo Danjoh, Senior Adviser, International Affairs, The Proprietary Association of Ja- ments and structural and operational requirements. Personal requirements mean that the pan, No. 17-20, I-chome, Kamikotoen, Nishinomiya, person who is fully responsible for either Hyogo prefecture 662-0813, Japan. 32 7 Downloaded from dij.sagepub.com at UNIV OF GEORGIA LIBRARIES on June 7, 2015
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Keigo Danjoh
manufacturing or importing the approved drug shall not be legally incompetent, or addicted to stimulants and the like. Structural and operati
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