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.
March 28, 2025
Approximately 5 minutes
Standards for Marketing Approval of Antitussives and Expectorants in Japan
Standards for Marketing Approval of Antitussives and Expectorants (Japan)
The Standards for Marketing Approval of Antitussives and Expectorants were issued by Japan’s Pharmaceuticals and Medical Devices Agency as Notification PB No.26 (with partial revision dated March 28, 2016). These standards set regulatory criteria for oral remedies intended to treat cough and sputum in Japan. Remedies not conforming to these standards require submission of supporting data for efficacy and safety. (PMDA, 000272490.pdf).
Scope
These standards apply to oral antitussives and expectorants, including tablets, capsules, pills, granules, powders, troches, drops, oral solutions and syrups. Remedies based on Kampo formulas or crude drugs alone are excluded. (PMDA, 000272490.pdf).
Active Ingredients
The standards include a Table 1 listing permitted active ingredients and their maximum single and daily doses. Combinations of active ingredients are allowed within defined limits, but some combinations are restricted or require justification. (PMDA, 000272490.pdf).
Quantities of Active Ingredients
Requirements specify:
- Maximum single and daily doses for each ingredient.
- Limits on combined doses when multiple ingredients are used.
- Lower limits for active ingredient amounts in combinations.
- Special provisions for ingredients in troches and drops. (PMDA, 000272490.pdf).
Dosage Forms
Approved dosage forms include tablets, capsules, pills, granules, powders, troches, drops, oral solutions and syrups; elixirs are excluded. (PMDA, 000272490.pdf).
Dosage and Administration
The general regimen is 3 to 4 times per day, with up to 5–6 doses per day for troches, drops, oral solutions and syrups under specified conditions. Age‑based restrictions apply: some formulations are not approved for young children or infants, and doses for children under 15 are adjusted by age coefficients. (PMDA, 000272490.pdf).
Indications
Indications include cough, cough associated with wheezing, and sputum. Additional symptom claims (e.g., sore throat or throat discomfort) may be allowed for troches and drops meeting specified ingredient criteria. Correspondence between active ingredients and allowable indications is defined in the standards. (PMDA, 000272490.pdf).
Packaging Units
The maximum container volume for oral solutions and syrups must provide no more than a four‑day supply at the adult maximum daily dose. (PMDA, 000272490.pdf).
Summary
These standards form the regulatory framework for antitussive and expectorant OTC drugs in Japan. Conformance with ingredient lists, dose limits, dosage forms, administration regimens, indications and packaging rules is essential for marketing approval. (PMDA, 000272490.pdf).
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