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Medicinal Products Regulatory Support in Japan

Overview

Japan is one of the largest pharma markets in the world. As per the resources, Japan imported 24% of its medicinal needs in the year 2020.

The Pharmaceuticals and Medical Devices Agency (PMDA), working under the Ministry of Health Labour and Welfare (MHLW), regulates the medicinal product registration in Japan. The registration of medicines is done under the Pharmaceuticals and Medical Devices Act (PMD Act).

With exceptional knowledge of pharmaceutical Regulatory Affairs in Japan & PMDA regulations, Freyr assists foreign manufacturers with medicinal products Regulatory support in Japan. To expedite your drug’s Japan market entry, Freyr offers comprehensive Regulatory services right from Regulatory intelligence to dossier preparation and submissions for drug approvals.

Drug Classification

For the registration of medicines, it is very crucial to identify the category of the product, as the Regulatory approval process totally depends on that. Based on the Pharmaceuticals and Medical Devices Agency (PMDA) regulations, drugs are classified as follows:

  • Generic Drugs
  • Prescription Drugs
  • OTC Drugs
  • Orphan Drugs

We, at Freyr Japan, help you identify the appropriate category, the respective Regulatory approval process, and the overall medicinal products Regulatory support in Japan.

Drug Registration

Based on the PMDA regulations, the registration of medicines in Japan depends on the classification of the drug product. A typical drug approval process in Japan with the Pharmaceuticals and Medical Devices Agency (PMDA) looks like such:

To import and sell drugs in the Japanese market, an entity must be registered with the Ministry of Health, Labour, and Welfare (MHLW). All manufacturers, foreign and domestic, must assign a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH).

For the pharmaceutical product registration, a foreign manufacturer must also be registered with the MHLW. The PMDA regulations state this process as “Foreign Manufacturer Registration (FMR).” The Pharmaceuticals and Medical Devices Agency (PMDA) then investigates and confirms whether the manufacturing site complies with the standards of the PMDA regulations through Good Manufacturing Practice (GMP) inspections. This PMDA inspection determines the GMP conformity. Other drug quality standards include Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP).

An application for approval is submitted to the PMDA, which conducts a review with the help of expert committees to determine the quality, efficacy, and safety of the drugs. Documents and reports required to be submitted with the application vary based on the categories. A foreign manufacturer of an Active Pharmaceutical Ingredient (API) is required to submit a Japanese Drug Master File (Japan DMF). He must appoint an in-country representative to submit the Japan DMF. After reviewing the Japan DMF, the PMDA provides a DMF registration certificate.

Once the positive results of GMP conformity and Regulatory review of the application are processed by the PDMA and MHLW, the product receives approval. The information on approved products is displayed on the Pharmaceuticals and Medical Devices Agency (PMDA) website.

We, at Freyr Japan, help you classify your drug and choose the respective Regulatory approval process, strategic planning, and execution of market entry with our overall medicinal products Regulatory support in Japan.

Important Validities

The Pharmaceuticals and Medical Devices Agency (PMDA) issues the Registration Certificate (RC) for five (05) years.

Frey Japan supports you with post-approval life cycle management of your product with overall pharmaceutical Regulatory Affairs in Japan.

Freyr Expertise

  • Regulatory Intelligence
  • Regulatory Due Diligence
  • Drug Registration
  • FMR
  • DMAH – MAH
  • DMAF Filing and In-country caretaking
  • GMP Conformity
  • Submission Management to PMDA or Notified Bodies
  • Translation Services
  • Data Reliability Inspection
  • QMS Inspection
  • Reimbursement Application Submission
  • Labeling and Artwork support
  • Distributor Identification and Qualification
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