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Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
January 19, 2025
Approximately 5 minutes
Standards for Marketing Approval of Nasal Drops for Rhinitis in Japan
Standards for Marketing Approval of Nasal Drops for Rhinitis (Japan)
The Standards for Marketing Approval of Nasal Drops for Rhinitis were issued by Japan’s Pharmaceuticals and Medical Devices Agency as Notification PB No.109 on February 1, 1991, with final revision on January 19, 2012. These standards define criteria for intranasal preparations intended for the relief of symptoms due to rhinitis. Preparations that do not conform to these standards must be supported by efficacy and safety data and justification for combinations. (PMDA, 000272499.pdf).
Scope
These standards apply to intranasally‑applied liquid medicines formulated for alleviating symptoms of acute rhinitis, allergic rhinitis and sinusitis. (PMDA, 000272499.pdf).
Active Ingredients
- Permissible active ingredients are listed in Table 1, including vasoconstrictors and other agents.
- Preparations must include at least one active ingredient from Column I of Table 1.
- Active ingredients from different columns may be combined, but only one ingredient per column I–IV is permitted when used together. (PMDA, 000272499.pdf).
Quantities of Active Ingredients
- Maximum concentrations for each ingredient are specified in Table 1.
- Minimum concentrations for Column I ingredients are half of the respective maximum; for other columns, minimum concentrations are one‑fifth of the respective maximum. (PMDA, 000272499.pdf).
Dosage Form
The dosage form covered by these standards is intranasally‑applied liquid preparations intended for nasal use. (PMDA, 000272499.pdf).
Dosage and Administration
- Preparations are to be applied intranasally no more than six times a day.
- Application method and intervals must be clearly stated, with intervals of at least 3 hours between uses.
- Dosages for infants under 2 years of age are not approved.
- For children under 7 years, the maximum concentrations may be half of the standard maximum concentrations. (PMDA, 000272499.pdf).
Indications
Indications must fall within relief of symptoms due to acute rhinitis, allergic rhinitis or sinusitis: stuffy nose, runny nose (excess nasal discharge), sneezing and dull headache (heaviness in head). (PMDA, 000272499.pdf).
Packaging Units
The maximum volume of containers for intranasal liquids is limited to 30 mL. (PMDA, 000272499.pdf).
Summary
These standards provide the regulatory framework for approval of nasal drops for rhinitis in Japan, covering ingredient types, concentrations, dosage forms, dosing instructions, indications, and packaging limits to ensure safety and efficacy. (PMDA, 000272499.pdf).
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