Contents:

CHAPTER 1 LEGAL FRAMEWORK 9 1.1 Japanese Ministry of Agriculture, Forestry and Fisheries guidelines 9 CHAPTER 2 DETAILED DATA REQUIREMENTS 11 2.1 Data on details or origin or discovery (development) of the product and the status of its use in foreign countries 11 2.2 Data on physical, chemical and biological properties, specifications and testing methods 12 2.3 Data on stability 12 2.4 Data on safety 14 2.5 Data on clinical studies 15 2.6 Residue studies 16 CHAPTER 3 REGULATORY PROCEDURES IN JAPAN FOR APPROVAL AND LICENSING 17 CHAPTER 4 WHERE TO FIND GUIDANCE ON JAPANESE REGULATORY REQUIREMENTS 19 CHAPTER 5 REGULATIONS IN CHINA 21 5.1 Chapter I General Provisions 22 5.2 Chapter II Research and Development of New Veterinary Drugs 22 5.3 Chapter III Manufacture of Veterinary Drugs 24 5.4 Chapter IV Distribution of Veterinary Drugs 27 5.5 Chapter V Import and Export of Veterinary Drugs 29 5.6 Chapter VI Use of Veterinary Drugs 31 5.7 Chapter VII Supervision and Administration of Veterinary Drugs 32 5.8 Chapter VIII Legal Liability 34 5.9 Chapter IX Supplementary Provisions 39 CHAPTER 6 PRODUCT REGISTRATION AND REGULATION IN INDIA 41 6.1 Introduction 41 6.2 Controlling bodies for product approval 41 6.2.1 Central Government 41 6.2.2 State Government 41 The Food and Drug Administration 41 6.3 Procedures for registration 42 6.3.1 Key registration requirements for a new product 42 6.3.2 Application procedure 42 6.4 Product Patent Protection 43 6.4.1 Background 43 6.4.2 Current Situation 43 6.5 Harmonization 46 6.6 Price control 47 6.6.1 Pricing norms for scheduled formulations 48 6.6.2 The Third Schedule 49 6.6.3 Drug Policy, 1994 50 6.7 Implications for the animal health industry 51 6.8 Drugs and Cosmetics Act, 1940 52 6.9 Drugs and Cosmetics Rules, 1945 52 LIST OF TABLES Table 1.1: Safety and efficacy data requirements for veterinary products in Japan Table 6.1: Effect of branding on pricing LIST OF FIGURES Figure 3.1: Approval procedure in Japan (1) Figure 3.2: Approval procedure in Japan (2) Figure 6.1: Pricing illustration

Summary:

Historically, getting products approved in Japan has been slower than in other regions and there are two reasons for this. First, data requirements in Japan have been rather specialized, and certain key data (for example, clinical trials) have always had to be generated in Japan. There has been some change in this recently and the Japanese authorities are now more ready to accept ‘foreign’ data than before. However, there remain certain key studies that must always be carried out in Japan and this can mean, in many cases, that studies that have already been carried out elsewhere must be repeated for submission in Japan. The second reason why submissions have been slow to progress in Japan is because of the need to set up a collaborative framework with personnel in Japan who can advise on the preparation of the data and actually carry out the submission in Japan, liaising directly with the Japanese authorities. In multinational companies these arrangements are already established but outside these organizations the collaboration has to be set up, sometimes using consultants who are based in Japan. Despite the differences compared with the EU and the US, many products are successfully authorized for sale in Japan, which remains a major commercial potential for any veterinary medicinal product that can be sold throughout the world. The information and guidance in this report will give you the necessary background to permit you to plan a submission in Japan and to discuss your plans with your chosen local collaborator. This report discusses the legislative framework in quite some detail. This is followed by an in-depth look at the filing procedure and includes an explanation of how the Japanese system functions.