Japan Regulatory Issues
Japan Regulatory Issues
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Historically Japan has been plagued with delays, with new drug approvals sometimes taking three or four years longer than in the US and EU.
Publisher: Datamonitor Healthcare
- Description
- Contents
- Samples
Historically Japan has been plagued with delays, with new drug approvals sometimes taking three or four years longer than in the US and EU. However, following the staff expansion at the Pharmaceuticals and Medical Devices Agency, the key Japanese regulator, review times have been slashed.
In 2009 new rules were implemented which allowed the Japan Patent Office to grant a patent for medicinal inventions with new dosages, dosage intervals, administration routes, or administration sites of known compounds. This has broadened the scope of patentable subject matter and will stimulate R&D in the industry.
Table of Contents
4 EXECUTIVE SUMMARY
5 DRUG APPROVAL PROCESS
6 The MHLW is the key regulatory decision-maker in Japan
7 The PMDA conducts scientific reviews of Marketing Authorization Applications
8 The PAFSC reviews pharmaceutical sanitation-related matters prior to new drug approvals
9 Marketing Authorization Applications and the evaluation process in Japan
13 Measures taken by Japan to reduce the drug lag period are showing results
16 References
18 INTELLECTUAL PROPERTY PROTECTION
18 The JPO provides IP protection
19 Patent term extensions
22 Data exclusivity
23 Drug counterfeiting in Japan
24 References
27 APPENDIX
27 Scope
27 Methodology
LIST OF FIGURES
5 Figure 1: Japanese drug approval authorities and their responsibilities
5 Figure 2: Structure of the regulatory system in Japan
6 Figure 3: Organization of the Ministry of Health, Labour and Welfare
8 Figure 4: Services of the PMDA
9 Figure 5: The drug approval process in Japan
12 Figure 6: Procedure for manufacturing and marketing of drugs for foreign manufacturers
14 Figure 7: Drug approval lag in Japan, 2006–10
15 Figure 8: Median review time and approved applications for standard review and priority
review products, 2012
18 Figure 9: Organization of the Japan Patent Office
20 Figure 10: The patent extension period in Japan
LIST OF TABLES
10 Table 1: Priority review and other special review systems in Japan
22 Table 2: Re-examination, data protection, and market exclusivity periods in Japan, US, and EU
Figure 1: Japanese drug approval authorities and their responsibilities
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