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revisions to the Pharmaceutical Affairs Law [35]. The company must submit all efficacy and safety data gathered since approval in a prescribed manner [36]. Drugs with an active ingredient or a combination prescription medicine not already approved underwent reexamination after 6 years from approval; however, since April 1, 1994, this has been extended to 10 years for many new medicines. Reexamination is necessary after 4 years for a product having the same active ingredient and route of administration as an already approved drug but with an additional indication or in a different dosage. As noted, it is difficult to register a drug that is a copy of a product in the original's reexamination period; thus, the extension of the period to 10 years is of distinct commercial value. |
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As occurs in many other markets, Japan requires all pharmaceutical products to undergo a periodic reevaluation of efficacy and safety every 5 years. For products requiring reexamination, reevaluation begins after that process has been completed. A reevaluation subcommittee advises the company when reevaluation is required, and the company has 4 months to submit the data for assessment. It is unusual for a drug to be removed from the market as a result of periodic reevaluation. Ad hoc reevaluation is conducted when a potential problem arises requiring urgent resolution. |
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A review of the Japanese approach to drug development and regulatory approval demonstrates significant differences from that in the United States and EU. Given the sensitivity surrounding the subject of public safety and medicines and the cultural variance between nations, it should be no surprise that Japan, the EU, and the United States have developed different approaches to the achievement of the same goal. A desire for harmonization of drug development and regulatory requirements and thus for the facilitation of regulatory acceptance of foreign data is not a new topic between the United States and Japan. The cooperative study for health and welfare that began in 1974 involved the exchange of information on pharmaceutical affairs, GMP, and GLP. This was followed by the MOSS discussions about acceptance of foreign data and aspects of harmonization that have been taken up by the tripartite endeavor of the ICH. Harmonization is not a one-way street and requires giving as well as receiving; with regard to Japan the will is there, at least in the Koseisho, but the rate of progress will be influenced by the senior Japanese physicians who sit on the decision-making committees of the CPAC. Although laws and guidelines may read alike, harmonization will require all parties to interpret the words similarly. History teaches us that the achievement of the latter is likely to require much longer than the agreement about the written word. |
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1. Pharmaceutical Industry in Japan 1992. Japan Pharmaceutical Manufacturers Association, July 1992. |
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