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There is no U S FDA law in Japan. In Nara, regulatory compliance for pharmaceuticals, medical devices, foods and cosmetics is governed by Japanese statutes administered by the MHLW and PMDA. People and companies in Nara seeking regulatory clarity should focus on Japan's Pharmaceuticals and Medical Devices Act and related laws rather than U S FDA requirements.
For cross-border matters when Japanese entities sell products in the United States, U S FDA compliance may still apply to those products entering the U S market. In such cases, you will need U S counsel in addition to Japanese regulatory counsel. A local attorney in Nara can coordinate with U S counsel to align both regimes and avoid conflicts.
PMD Act reforms introduced a unified framework for marketing authorizations, post-market surveillance, and safety actions for medicines and medical devices in Japan.
Source: PMDA and MHLW regulatory resources discuss the PMD Act framework and its implementation in Japan. See PMDA English resources and MHLW English guidance for cross-border regulatory planning.
Key references:
A Nara-based company plans to bring a new drug to market. A regulatory attorney can identify whether you need PMD Act marketing authorization, target review pathways, and prepare a compliant submission package for PMDA.
A local distributor faces a post-market safety issue or a product recall. An attorney can help navigate mandatory safety actions, corrective measures, and communication with PMDA and authorities.
An importer wants to bring a U S or other foreign device into Japan. A lawyer can guide the import licensing process, labeling requirements, and conformity assessment under PMD Act and related laws.
A Nara hospital or clinic plans to conduct a clinical trial or regenerative medicine study. Legal counsel helps with trial approvals, ethics committee alignment, and PMDA interactions.
A startup considers regenerative medicine or advanced therapies. An attorney can explain the Regenerative Medicine Act pathways and how to structure safety protocols and facility designations.
Existing product labeling or advertising raises questions about compliance with PMD Act and Food Sanitation Act. A lawyer can assess claims, labeling, and disclosures to avoid violations.
The regulatory environment in Japan features several core laws that govern FDA-like concerns for products and devices. Below are two to three key statutes with context on their scope and recent developments.
The PMD Act provides the current framework for marketing authorization, quality control, safety surveillance, and post-market actions for medicines and medical devices in Japan. It superseded the Pharmaceuticals Affairs Law and established new pathways for review and post-market oversight.
Effective dates and notes: The PMD Act was enacted in 2013 and effective reforms began in 2014, aligning practices across drug and device regulation. The law continues to evolve with amendments aimed at safety and efficiency in approvals and post-market actions.
Source: PMDA and MHLW guidance discuss the PMD Act’s structure, scope, and regulatory responsibilities. See PMDA English materials for overview and procedures.
“The Pharmaceuticals and Medical Devices Act introduces a unified framework for regulatory review, post-market safety, and compliance for medicines and devices.”
This Act governs the safety, oversight, and implementation of regenerative medicine and cell-based therapies in Japan. It provides special pathways for innovative therapies and outlines requirements for facilities, consent, and post-market safety management.
Effective context: Enacted in 2014 as part of the regulatory modernization alongside PMD Act, with subsequent updates to clarify protocols and oversight. The law affects Nara-based research institutions and healthcare providers engaging in regenerative medicine activities.
Source: PMDA and MHLW explain the framework for regenerative medicine oversight and approvals. See PMDA English resources for regenerative medicine guidance.
“Regenerative medicine safety and oversight are structured to enable innovation while protecting patients.”
The Food Sanitation Act governs safety, labeling, and import restrictions for foods and beverages, including dietary supplements and related products that may bear health or safety claims. While not a medical product law, it intersects with FDA-like concerns in labeling and consumer safety.
Context: The act has been amended multiple times since 1947, with important updates to labeling, ingredient disclosures, and import controls. In practice, firms in Nara must ensure that product labels and claims comply with this Act when selling food or supplement items in Japan.
Source: Official Japanese texts and guidance outline labeling and safety requirements. See e-Gov and MHLW resources for details.
The PMD Act regulates marketing approvals, safety surveillance, and post-market actions for medicines and devices in Japan. In Nara, manufacturers and distributors must obtain PMDA authorization and comply with ongoing safety obligations.
Timeline varies by product class and data. Typical timelines range from several months to over a year, with expedited routes available for innovative therapies under Sakigake Designation.
Marketing approval submissions go to the PMDA. You may need to work with a local regulatory affairs professional in Nara to prepare and coordinate with PMDA review teams.
A local attorney understands prefecture-level health authority expectations and can manage timelines, communications, and documentation with PMDA more efficiently.
Yes, for substantive filings, translations, and cross-border considerations. A local lawyer can help with Japanese language submissions and regulatory nuance.
Sakigake is a fast track designation for innovative therapies to accelerate regulatory review. Eligible products are typically high-innovation medicines or devices with substantial clinical promise.
No. Importing regulated products into Japan requires compliance with PMD Act and related regulations, regardless of U S FDA status.
Costs vary by firm and scope. Expect initial consultations to range from a few tens of thousands to several hundred thousand yen, with larger projects priced by scope and complexity.
The PMD Act took effect in 2014, consolidating and updating previous pharmaceutical and medical device regulations. It introduced unified review pathways and post-market oversight controls.
Yes. The PMD Act replaces the old Pharmaceutical Affairs Law with a broader framework for medicines, medical devices, and safety oversight, including post-market actions.
The Regenerative Medicine Act provides oversight for cell-based therapies and promotes safe clinical use. Nara startups pursuing regenerative therapies should plan for facility requirements and patient safety measures.
Yes, if your products are foods or supplements marketed in Japan. The Food Sanitation Act governs labeling, safety, and import compliance for such items.
Define your product category and regulatory path. Identify if PMD Act, Food Sanitation Act, or other law applies in your case, and determine whether cross-border U S considerations exist.
Gather documents and create a regulatory dossier. Include data, quality controls, labeling samples, and safety evidence needed for PMDA submissions or inspections.
Engage a Nara based regulatory attorney or consultant with PMD Act experience. Confirm language capabilities, timelines, and fee structures before starting.
Schedule an early consultation with PMDA or local health authorities. Prepare questions about routes, data requirements, and post-market obligations.
Prepare your submission or compliance plan with a clear timeline. Build a post-market surveillance plan and labeling strategy aligned with PMD Act requirements.
Execute the filing and respond promptly to requests for information. Maintain ongoing documentation and monitor for any regulatory changes affecting your product.
Review cross-border considerations with U S counsel if you plan to enter the U S market. Align Japan and U S regulatory strategies to avoid delays.
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