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Life Science Compliance Services in Japan
From mind to market with timely strategic solutions, faster approvals and end-to-end regulatory support services.
Arixio provides you with comprehensive regulatory services in Pharmaceuticals, Medical Devices, Cosmetics, Biologics, Nutrition and Animal health & Welfare sectors. Compliance with the regulatory requirements is a complex process but is the foundation for a successful regulatory product approval. Collaborate with Artixio for absolute regulatory compliance and solutions, product registration, market entry and ongoing product support services.
Regulatory Authority of Japan
The Pharmaceuticals and Medical Devices Agency (PMDA) holds the responsibility for regulating the pharmaceuticals and medical devices in Japan. The PMDA, established in April 1, 2004, works together with the Ministry of Health, Labour and Welfare (MHLW) in controlling these products. The other pharmaceutical and healthcare products including biologics, cosmetics and food supplements are regulated by PMDA, MHLW and the Department of Food Safety respectively. The Ministry of Agriculture, Forestry and Fisheries (MAFF) holds the authority to regulate veterinary products in Japan.
The PMDA reviews the data submitted to the MHLW for the products that PMDA governs and is then approved for commercial distribution if it is of safety, quality and efficacy. GLP (Good Laboratory Practice) /GCP (Good Clinical Practice) /GPSP (Good Pharmacovigilance System Practice) compliance assessment and GMP (Good Manufacturing Practice) /QMS (Quality Management System) /GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practice) inspections are included in the PMDA review system.
PMDA provides relief compensation for the public suffering from adverse drug reactions and infections acquired by pharmaceuticals or any biological products. The PMDA also performs scientific review of the medical devices and pharmaceutical’s marketing authorization application, their post marketing safety monitoring.
All in One, Here at Artixio
With all these safety regulations, compliance assessments and stringent requirements, it is a complex process to take a product from its testing phase to the marketing phase. This can be more challenging when new to PMDA regulations. Artixio provides regulatory intelligence, customized solution services and provides step by step guidance and checklists to be satisfied at each regulatory stage. Our regional experts with 15 -35 years of experience have guided and helped clients new to the Japan health authority to gain product registration and approvals. We have achieved 5000+ successful approvals with our 20+ years of experience.
Our regional experts in Japan are focused on being up to date with the evolving regulatory requirements and are dedicated in providing pre and post registration services. Our professional network with PMDA health authority facilitates faster approvals by avoiding any incomplete submissions to the authority. Artixio’s team of experts, local, regional and global regulatory professionals not only help with publishing and submission services but also offer testing, regulatory operation services, labeling and artwork, gap assessment, pharmacovigilance and other comprehensive regulatory services as well.
Why is Artixio the Best?
A misconception is that after product approval or licensing, there isn’t much left to do or to be compliant with. But the truth is that, even after market entry, the product is still under regulatory observation and noncompliance with the post marketing requirements and submissions can lead to product recalls/ cancellation from the market. Artixio provides PMS, product lifecycle management and other ongoing support services for your product. Artixio is well equipped with the knowledge of region-specific pre-registration, registration and post registration activities to be followed to maintain the product in the market. Ensuring safe, quality & effective functioning of the product in the long run is another area of expertise for Artixio.
Our Regulatory Services in Japan
Pre-registration
Market research, Regulatory intelligence and strategy, Technical due diligence, Product development services, Technical and medical writing and other pre-registration services.
Registration
Product registration (IND, NDA), Artwork and labeling, Publishing and submission services, PMDA liaison and MAH services, testing, PMDA/ MHLW audit support, product approval services, and all other registration associated services.
Post registration
Market entry services, Post market Surveillance, Product lifecycle management services, performance evaluation reports, Advertisement and promotional material review, Digital marketing and other ongoing support services.
Services through all phases
Regulatory solutions and strategies, Response to regulatory queries, Market access, Gap assessment, Pharmacovigilance, Quality services.
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Why Partner with Us?
Successful approvals and ongoing product lifecycle maintenance for 200+ products.
Diverse products experience across complex products categories and therapeutic areas.
Strong regional expertise, experts with 15-35 years of experience.
Proven experience in end-to-end product value chain from concept to commercialization.
PMDA experience in navigating through complex, often ambiguous regulations.
Intelligence driven, global regulatory services supported by Dvarka.
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 all PMDA functions.
Industries We Serve in Japan
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
What is the SAKIGAKE Designation System in Japan?
The SAKIGAKE designation system was developed by MHLW in 2014. This was launched with an aim for early practical application for innovative medical products which are effective treatment for severe illness or rare diseases. This system offers several advantages like rapid review, prioritized consultation, premium drug pricing and extended data protection period. The designation criteria for a product to undergo SAKIGAKE system are: i) Primarily developed in Japan and must be planned for an application for approval, ii) depending on the mechanism of action, non-clinical study and early phase of clinical trials data, prominent effectiveness can be expected.
What is the application review time for products under PMDA?
If the product is subjected to a priority review process, then the target time is 9 months. If the product is going through a standards regulatory review process, then it is 12 months. The PMDA has set targets aiming to complete at least 80% of the applications (priority or standard) to be reviewed within the mentioned time frame. This is done to streamline the process of product approval. It can vary according to the complexities of the dossiers provided.
Does PMDA offer consultation meetings?
Yes, PMDA offers consultation meetings to provide guidance and advice on the clinical trials of the products and regarding the data for regulatory submission. In the clinical trial consultations, the PMDA checks whether the trial is in compliance with the standards of regulatory submissions. Ethical and scientific aspects, reliability of the trial, safety of the subjects are also taken into consideration. Moreover, PMDA provides advice to promote so as to improve the clinical trial.
Are there any consultation fees?
Yes, a fee is to be paid for consultation meetings. The consultation meeting regarding R&D or regulatory submissions must be paid but the same topics can be clarified free of cost in a pre-consultation meeting. Here is the link for the fees to be paid for face-to-face advice, safety test inspections and other services. https://www.pmda.go.jp/files/000272392.pdf
What are the sections that do not come under the control of PMDA?
Patents on medical products, Food products including supplements, cosmetics, pricing and reimbursement of medical products, medical products for animal use, Japanese Pharmaceutical Excipients and Japanese Pharmaceutical Codex, distribution, import of and marketing license of medical products, licensing for wholesale distribution are the areas which are not under the control of PMDA.
Our Global Reach: Serving Life
Sciences Clients Worldwide
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Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
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Japan
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