Economic and Legal Framework for Non-Prescription Medicines. Brussels: Association of the European Self-Medication Industry, 2003. This textbook assembles background information on various aspects of production, registration, and marketing of OTC medications worldwide. In chapters for each of 32 countries, topics addressed include: advertising to the general public, patient information, pricing, import restrictions, use of trademarks, training and attitudes of pharmacists and doctors, market data, and the "switch climate'' (potential for—and constraints upon—migration of products from prescription to OTC status).
Russell KB, Bremer M. New Drug Approval in Japan. Waltham, MA: PAREXEL International, 2002. The authors provide a thorough analysis of Japan's reorganized regulatory agency structure, its streamlined NDA process, and its rapidly evolving policies toward the acceptance of foreign clinical data.
Kong L. How to Register Drugs in China. Richmond, Surrey, U.K.: PJB Publications, 2003. Subtitled A Guide to China's New Drug Registration Procedures, this Scrip Report explains approval procedures for new drugs and biological products. China's entry into the World Trade Organization led to sweeping changes in regulatory protocols, effective in December 2002. The author provides a step-by-step guide to compliance, including discussion of imports, technology transfers, reregistrations, and supplementary applications. PJB offers both hardcopy and electronic (HTML or PDF) subscriptions to this publication.
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