Asian Animal Health Regulations

Publication Date	January 2007
Publisher	Animal Pharm
Product Type	Report
Pages	57
ISBN Number	not applicable
Product Code	ANP00011

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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.

Content

CHAPTER 1 LEGAL FRAMEWORK
- 1.1 Japanese Ministry of Agriculture, Forestry and Fisheries guidelines
CHAPTER 2 DETAILED DATA REQUIREMENTS
- 2.1 Data on details or origin or discovery (development) of the
- product and the status of its use in foreign countries
- 2.2 Data on physical, chemical and biological properties, specifications
- and testing methods
- 2.3 Data on stability
- 2.4 Data on safety
- 2.5 Data on clinical studies
- 2.6 Residue studies
CHAPTER 3 REGULATORY PROCEDURES IN JAPAN FOR APPROVAL AND
- LICENSING
CHAPTER 4 WHERE TO FIND GUIDANCE ON JAPANESE REGULATORY
- REQUIREMENTS
CHAPTER 5 REGULATIONS IN CHINA
- 5.1 Chapter I General Provisions
- 5.2 Chapter II Research and Development of New Veterinary Drugs
- 5.3 Chapter III Manufacture of Veterinary Drugs
- 5.4 Chapter IV Distribution of Veterinary Drugs
- 5.5 Chapter V Import and Export of Veterinary Drugs
- 5.6 Chapter VI Use of Veterinary Drugs
- 5.7 Chapter VII Supervision and Administration of Veterinary Drugs
- 5.8 Chapter VIII Legal Liability
- 5.9 Chapter IX Supplementary Provisions
CHAPTER 6 PRODUCT REGISTRATION AND REGULATION IN INDIA
- 6.1 Introduction
- 6.2 Controlling bodies for product approval
- 6.2.1 Central Government
- 6.2.2 State Government
- The Food and Drug Administration
- 6.3 Procedures for registration
- 6.3.1 Key registration requirements for a new product
- 6.3.2 Application procedure
- 6.4 Product Patent Protection
- 6.4.1 Background
- 6.4.2 Current Situation
- 6.5 Harmonization
- 6.6 Price control
- 6.6.1 Pricing norms for scheduled formulations
- 6.6.2 The Third Schedule
- 6.6.3 Drug Policy, 1994
- 6.7 Implications for the animal health industry
- 6.8 Drugs and Cosmetics Act, 1940
- 6.9 Drugs and Cosmetics Rules, 1945
LIST OF TABLES
- Table 1.1: Safety and efficacy data requirements for veterinary products in Japan
- Table 6.1: Effect of branding on pricing52
LIST OF FIGURES
- Figure 3.1: Approval procedure in Japan (1)
- Figure 3.2: Approval procedure in Japan (2)
- Figure 6.1: Pricing illustration