本報告已在2011年08月03日停止出版。
Abstract
"Historically, getting products approved in Japan has been slower than in
other regions … However there has been some change in this recently
‘foreign’ data is becoming more acceptable."
This single volume report, is a concise summary of the legislative framework
and the filing procedure for achieving product approval in Asian markets.
Key coverage
- 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.
Key findings
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.
Chapters include
Legal framework, detailed data requirements, regulatory procedures in Japan
for approval and licensing, where to find guidance on regulatory requirements,
regulations in China, product registration and regulation in India.
Who should read this report?
This report will be an ideal guide for:
- Newcomers to the regulatory profession
- Generics manufacturers in or outside of Asia
- Or drug developers wanting to market their products in Asia
Table of Contents
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 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
