Pharma Regulatory Affairs Consulting Services in Japan

Artixio supports pharmaceutical companies in Japan with practical regulatory affairs consulting services to meet PMDA and MHLW requirements. Our team helps manage product registration, clinical submissions, and ongoing updates with local insight. We make the regulatory process clearer and more manageable for global and domestic pharma businesses.

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Artixio has collaborated with over 50 global pharma companies and have delivered strategic market entry to their products. With 30+ years of hands-on experience, we offer pharmaceutical regulatory affairs consulting services in Japan that fits the needs of both new market entrants and established brands.

Right from development to registration and post approval support, Artixio provides comprehensive, integrated, regulatory and market intelligence driven services across strategy, writing, dossier preparation, publishing, labelling, artwork, ad-promo and regulatory information management.

Pharmaceutical Registration in Japan (PMDA)

The regulatory body looking for the pharmaceuticals is Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It is responsible for the evaluation and approval of the drug products, medical devices and other related products. In addition, they also monitor clinical trials ensuring the product safety and later on conducts the post marketing surveillance. To effectively navigate Japan’s regulatory framework, companies generally engage local legal experts or regulatory consultants who are specialized in pharmaceutical compliance.

Classification of Pharmaceuticals in Japan

The pharmaceutical drug products in Japan are classified as-

General drugs– these are standard drug products like the over the counter (OTC) medicines. Usually the safety track records of these drug products are maintained.

New Drugs– They are the recent innovations and contain the active pharmaceutical products that are not approved in Japan.

Quasi Drugs– These are the entities that are considered as drugs but have some medicinal values.

Pharmaceutical Regulatory Affairs In Japan

Pre-Registration process

The companies that want to launch their product in Japan have to go through extensive research as non-clinical and clinical trials and followed by market authorization procedure.

Registration Process

For registering the pharmaceutical products in Japan either one can apply for new drug application or general drug application to PMDA. The application must include the information regarding manufacturing process, safety, quality and labelling. The application gets reviewed by the PMDA thoroughly. Before granting approval, on-site inspection by PMDA will also be there for the verification of regulatory compliance.

Registration Process for Pharmaceuticals in Japan (PMDA)

The Market Authorization Holder in Japan is usually a distributer, or a third party organisation from Japan only or the foreign pharmaceutical company have its own office in Japan or GQP/GVP Conformity.

Post Marketing Surveillance

After approval, the parent company must have systems to maintain the safety reports and adverse effect reports. If any amendment is there, the company needs to inform the PMDA. Besides, MAH and licenses needs renewal within every 5 years. The PMDA also conducts regular audits for ensuring the regulation compliance as well.

Foreign Manufacturer Registration (FMR) in Japan

A foreign manufacturer if planning to manufacture and import any drug product or API overseas they have to get registered with MHLW this is known as FMR or Toroku.

Artixio offers a range of services to assist pharmaceutical companies with product registration in Japan:

Medical & Technical Writing
Due Diligence and Gap Analysis
Dossier Preparation and compilation
Dossier Publishing & Submission
Product Registration
Marketing Authorization Holder (MAH/LR)
Investigation New Drug Application (IND) / Clinical Trial Application (CTA)
New Drug Application (NDA) / Marketing Authorization Applications (MAA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
Distributor and Import Assistance

Collaborate with Artixio’s Japan Expertise with Seamless Global Delivery

Successful Approvals and Product Lifecycle Maintenance for 300+ products
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expert with 30+ years of experience
Proven Experience in End-to-End Product Value Chain from Concept to Commercialization
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Regulatory functions

FAQS About Regulatory Affairs

1. What act governs the drug product registration in Japan?

The Pharmaceuticals and Medical device act (PMD Act) governs the drug product registration in Japan.

2. For drug registration, does any local representative is required?

Yes, in Japan the market authorization holder (MAH) must have office in Japan or any pharmaceutical company must have a Designated Market authorization holder (DMAH) if they do not have any legal entity in Japan.