Licensing Guidelines and Regulations

First posted: 27/01/2012

The healthcare system in Japan provides healthcare services including screening examinations, prenatal care and infectious disease control, with the patient accepting responsibility for 30% of these costs while the government pays the remaining 70%.

Enrolment in one of Japan’s health insurance programmes is compulsory for residents of Japan. People without insurance through employers can participate in a national health insurance programme administered by local government.

Drug products may be placed on the market in Japan after approval by the competent authority. The legal basis for drug approval is based on Article 14-11-1 of Pharmaceutical Affairs Law (R-PAL) of 1 April 2005 [1].

The regulatory body for Japan is the Ministry for Health Labour and Welfare (MHLW). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs.

All companies marketing originator drugs in Japan must perform post-marketing surveys on new drugs so that efficacy and safety can be reconfirmed by re-examination by the MHLW for a specified period of eight years since 1 April 2007. Applications for generic drugs cannot be filed until completion of the re-examination and expiration of patents, which last for 20 years in Japan. Brand-name products are protected from generics during this period.

Approval of medicines for human use is the responsibility of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. Equivalency of generic drugs that are supposed to be equivalent to new drugs are examined by the MHLW through the PMDA based on the drug organisation’s research on equivalency to already approved items [2].

Within the PMDA, the office for OTC and generic drugs is responsible for review of generic drug applications [3].

The Japanese government has set a target to raise the share of generic medicines per unit to 30% or more by 2012. The MHLW established the ‘Action Programs for Promoting Safe Use of Generic Medicine’ in October 2007 and efforts have been made in accordance with this programme to gain the trust of patients and medical professionals with regard to generic medicines.


1. Japan Generic Medicines Association. Drug master file application procedures in Japan. 2009 Apr 22.

2. Pharmaceuticals and Medical Devices Agency (PMDA), Japan. [homepage on the Internet]. Japan, PMDA [cited 2012 Jan 27]. Available from:

3. Japan Pharmaceutical Manufacturers Association (JPMA), Japan. Pharmaceutical administration and regulations in Japan [monograph on the Internet]. Japan, JPMA [cited 2011 Nov 17]. Available from:

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