Localization
Nishimura & Asahi / Japan
The key facts about localization in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 75.
1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?
No, there are no rules or regulations requiring and/or encouraging localization in Japan. This means that the decision about whether to import and sell pharmaceuticals made in foreign countries or sell domestically manufactured ones is generally left to the judgement of distributors.
Please note that no person other than one who has obtained marketing authorisation from the Minister of Health, Labour and Welfare (“MHLW”) may engage in the business of marketing pharmaceuticals in Japan; this regulation is provided in the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices. In relation to obtaining such license, this law requires that the applicant should have methods for quality control for pharmaceuticals which comply with the standards specified by the Order of MHLW for the purpose of obtaining such license, and one such order is the Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices. According to this order, a marketing authorisation holder shall have a person designated beforehand in its quality assurance department or manufacturing department who evaluates the results of the manufacturing control and quality control and makes decisions concerning the market release for each lot. This rule applies to distributors (marketing authorisation holders) who sell pharmaceuticals imported from foreign countries.
2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?
N/A
3. Is the process of obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
N/A
4. Is the pricing process for pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
N/A
5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
N/A
6. Is the access to public or public tenders of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?
N/A
7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?
N/A
8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?
N/A
9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?
There is no current discussion about the possibility of implementing localization policies in Japan.
