Regulatory Affairs Consulting Services for Pharmaceuticals 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.
Services We Offer
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
Why Choose Artixio for Regulatory Affairs in Japan?
- 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.
3. What is the timeline for drug registration in Japan?
The review process after submission of application usually takes 12-18 months.
4. What are the accelerated approval frameworks in Japan?
There are 3 such frameworks- Sakigake which is used for innovative/new drugs, priority review and orphan drug registration.
5. What is the language used for submitting the application to PMDA?
PMDA only accepts the applications that are in Japanese language.
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Medical & Technical Writing
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Investigation New Drug Application (IND)
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Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review
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