Types of Registration Application for Pharmaceuticals in Japan: In a nutshell

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Pharmaceuticals and Medial Device Agency is the is the regulating Authority for Pharmaceuticals in Japan. This Agency came to force on 1/04/2014.

The various registration Application are as follows:

1.Clinical Trial Notification for New drug development (IND).

2.New Drug Approval Application.

3.Generic Drug Approval Application.

4.Orphan Drug Application.

5.Priority review.


1. Clinical Trial Notification for New drug development (IND):

Ø  This Application is important if the company intends to conduct clinical trial for a drug and to collect data for applying for manufacturing/marketing.

Ø  The Clinical trial should be conducted as per Good Clinical Practice.

Ø  If the Clinical trial is conducted for drugs with new APIs, Drugs with new route of administration, or if the drug is a new combination product, the clinical trial protocol has to be submitted.

Ø  The review of application till takes 30 days after start of clinical trial.

Ø  The documents required for application are clinical study protocol, Consent form, Sample of Case report form, Latest Investigators Brochure.

2.New Drug Approval Application:

Applicant files New drug Application to PMDA—PMDA will review the Application and report shall be submitted to MHLW.

Ø  Later, MHLW consults Pharmaceutical Affairs and Food Sanitation Committee and PAFSC will submit the report and advice to MHLW.

Ø  If the application meets the requirements, the Approval shall be given to Applicant

Ø  Review timeline is 12 months.

Ø  The Application shall be submitted in eCTD format.

Ø  On site inspection is conducted by PMDA for checking the quality.

Documents required are: Stability data, origin/background of study, manufacturing methods information, clinical trial results.

3.Generic Drug Approval Application:

Ø Application for generic drug cannot be filed until the completion of reexamination.

Ø   Branded products are protected under patents.

Ø  PMDA review data like, specifications and test methods, stability test, BA&BE data of generic drug to original drug

Ø  Review timeline is 10 months.

Ø  Documents required: Origin, purity, strength, dosage form.

4.Orphan Drug Application:

Ø  MHLW, PMDA and National Institute of Biomedical Innovation are responsible.

Ø  After consultation, Applicant submit original and copy of application fir designation to evaluation and licensing division under Pharmaceutical and Food Safety Bureau.

Ø  Application should be in Japanese language.

Ø  After review, the designation notice shall be sent to applicant. The designation name of drug, Indications, Name and address of applicant will be published in the gazette notification.

Ø  Few documents required are: Data on number of patients, data on medical needs, development plan, data on draft dossier.

Ø  The review timeline is 9 months

      5.Priority review Criteria:

Ø  For Orphan drugs and other drugs considered important from a point of view which is used to treat serious diseases.

Ø  These drugs are evaluated/Approved on priority basis.
Ø  The step follows like:
The drug designated for priority review—Expert opinion by PMDA—Based on report, Evaluation and Licensing Division notifies the decision if to apply or not—PAFSC consulted and final decision is made.
Ø  Criteria for designation:
·       Seriousness of Indicated diseases (Fatal/Progressive and irreversible/Others).
·       Overall Assessment of Therapeutic usefulness (There is no existing methods of treatment, Efficacy, Safety).

Ø  The review timeline for Application is 9 months.

The PDF can be accessed from below.


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