Asian Animal Health Regulations

• Take a detailed look at the legislative and regulatory framework in place — particularly for Japan and China
• Understand the filing procedures required to bring an animal drug product to market in Asia effectively and efficiently
• Use the report to plan a submission and to help you discuss your plans with your chosen local collaborator
• Discover the problems faced by the Chinese veterinary medicines industry and the recent regulations implemented that could mean opportunities for your business

• 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 Chinese industry has an urgent need for standardization. As the market opens, China will be flooded with imported products. For domestic producers to be able to compete, the regulatory system needs urgent improvement.
• Find out the main acts and regulations as well as guidance on getting approvals and practical tips to speed up the approval process.
• Examine the regulatory culture in the rapidly expanding Indian market, which has been reluctant to adopt global policies due to the nature of that particular market. Changes since the last Animal Pharm report on the Indian animal health market are listed and discussed.

• Newcomers to the regulatory profession
• Generics manufacturers in or outside of Asia
• Or drug developers wanting to market their products in Asia.

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 41 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 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