Local Regulatory Experts
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.
October 25, 2025
Approximately 5 minutes
Standards for Marketing Approval of Cold Remedies in Japan
Standards for Marketing Approval of Cold Remedies in Japan
The Standards for Marketing Approval of Cold Remedies were issued by Japan’s Pharmaceuticals and Medical Devices Agency as Notification PB No.28 on March 25, 2015. This provisional English translation is for reference; the Japanese original is authoritative. The standards specify criteria for the approval of over‑the‑counter (OTC) cold remedies in Japan. (PMDA, 000272504.pdf).
Overview
Cold remedies are regulated as OTC drugs and must conform to detailed criteria related to active ingredients, dosage forms, dosing and administration, indications and packaging to obtain marketing approval in Japan. (PMDA, 000272504.pdf).
Active Ingredients and Maximum Daily Doses
The standards include a comprehensive Table 1 listing active ingredients and their maximum daily doses across categories such as analgesics, antihistamines, cough suppressants and expectorants. For example, acetaminophen, ibuprofen and aspirin are assigned specific upper limits. When components are combined, total exposure is constrained by combination rules. (PMDA, 000272504.pdf).
Dosage Forms
Approved dosage forms include tablets, capsules, pills, granules, powders and syrups. Each form must meet the standards’ specifications. (PMDA, 000272504.pdf).
Dosage and Administration
Oral products, except syrups, are taken three times a day within 30 minutes after meals. Syrups are taken after meals and, when necessary, before going to bed or up to six times a day with at least four hours between doses. Age‑based restrictions apply, e.g., most oral forms are not approved for children under certain ages (e.g., under 3 or 5 years) depending on dosage form and ingredients. (PMDA, 000272504.pdf).
Indications
Cold remedies are indicated for symptomatic relief of common cold symptoms: runny nose, stuffy nose, sneezing, sore throat, cough, phlegm (sputum), chills, fever, headache, joint pain and muscle pain. Certain symptom claims depend on inclusion of relevant active ingredients listed in the standard’s tables. (PMDA, 000272504.pdf).
Packaging Units
For syrups, the maximum container volume is limited to a two‑day supply at the maximum daily dosage for children aged 6 years, ensuring appropriate pediatric supply and safety. (PMDA, 000272504.pdf).
Conclusion
These standards provide a clear regulatory framework for developers and manufacturers of OTC cold remedies in Japan. Conformance with the active ingredient limits, dosage forms, administration requirements, indication definitions and packaging rules is essential for marketing approval. (PMDA, 000272504.pdf).
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