PMDA-Compliant Pharmaceutical Promotional Materials
Ensure your pharmaceutical promotional content meets PMDA Pharmaceuticals and Medical Devices Act, MHLW guidelines, and JPMA Fair Competition Code requirements. Streamline Japanese market compliance with automated claim extraction and reference validation.
The Challenge of Japanese Pharmaceutical Compliance
Key PMDA & JPMA Requirements
- • Pharmaceuticals and Medical Devices Act (PMD Act) Article 66-68 (advertising regulations)
- • JPMA (Japan Pharmaceutical Manufacturers Association) Fair Competition Code
- • MHLW (Ministry of Health, Labour and Welfare) advertising guidelines
- • Package Insert (PI) alignment and approved indication compliance
- • Japanese clinical trial data requirements (J-trial preference)
- • Pre-approval promotional material review by PMDA
How PromoPack Ensures PMDA & JPMA Compliance
Automated PMD Act & JPMA Code Compliance
Every promotional material is validated against PMD Act and JPMA Fair Competition Code requirements, ensuring compliance with Japanese advertising standards before PMDA submission.
Package Insert Alignment
Validates that all claims align with PMDA-approved Package Insert (Tenpu Bunsho) content.
Indication Compliance
Ensures promotional materials strictly adhere to approved indications—critical for PMDA review.
Japanese Trial Data Priority
Prioritizes Japanese clinical trial data per MHLW preference for domestic evidence.
Fair Competition Code
Validates compliance with JPMA Fair Competition Code for ethical promotional practices.
PubMed + J-STAGE Integration
Access 36M+ PubMed citations plus J-STAGE (Japanese Science and Technology Information Aggregator) to support claims with Japanese-language research meeting PMDA substantiation requirements.
Japanese Clinical Data Preference
PMDA requires Japanese clinical trial data when available. PromoPack automatically prioritizes J-trial data and Japanese medical journals in reference suggestions.
- ✓ J-STAGE database integration (Japanese biomedical literature)
- ✓ UMIN-CTR (Japan trial registry) integration
- ✓ Japanese-language abstract support
- ✓ Priority ranking for Japanese Journal of Clinical Oncology, etc.
PMDA Submission Packages
Generate submission-ready packages for PMDA promotional material review:
- Claims & References Report: Complete mapping of promotional claims to supporting literature (Japanese & English)
- Package Insert Alignment: Documentation showing consistency with approved Tenpu Bunsho
- Audit Trail: Complete documentation of review and approval workflow
- Japanese/English Documentation: Bilingual reference support for international companies
Why Japanese Pharma Teams Choose PromoPack
Ready to Streamline Your PMDA Submissions?
Join Japanese pharmaceutical companies using PromoPack to reduce PMDA review cycles and ensure PMD Act compliance.