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Regulatory Authority:
The National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health Malaysia is responsible for the screening, evaluation and approval of pharmaceutical Regulatory submissions in Malaysia.
1. Primary Language for Regulatory Submissions
- All Regulatory dossiers, technical documentation, and application forms for pharmaceuticals must be submitted in English.
- The expectation is that scientific and technical documents—including the ASEAN Common Technical Dossier (ACTD) and relevant Module sections—are provided in English to facilitate review by the NPRA.
2. Product Labeling and Package Insert Requirements
- Labeling (including the package insert, outer packaging, and inner packaging):
- Must be provided in both English and in Bahasa Malaysia (Malay) for certain specific statements as per labeling requirements
- All medicinal products marketed in Malaysia require bilingual labels to ensure that healthcare professionals and consumers understand usage instructions and warnings.
- Patient Information Leaflet (PIL):
- Should be available in both English and Bahasa Malaysia, ensuring accessibility and patient comprehension.
3. Application Forms and Administrative Documents
- Most administrative forms can be submitted in either English or Bahasa Malaysia.
- Any official correspondence with government ministries or certain notifications might be required in Bahasa Malaysia, depending on the context.
4. ASEAN Harmonization
- Malaysia adheres to the ASEAN Common Technical Dossier (ACTD) format, in which English is the required language for all technical data and supporting scientific information.
5. Exceptions and Translations
- If a document is originally written in another language, an accurate certified English translation must be provided.
- The NPRA reserve the right to request translation of any submitted documents into English or Bahasa Malaysia if necessary for the assessment process.
Summary Table: Language Requirements by Document Type
Document Type | Language |
| Dossier (all modules/ACTD) | English |
| Scientific/Technical Data | English |
| Application Forms | English/Malay |
| Package Insert & Labels | English & Malay for certain specific statements as per labelling requirements |
| Patient Information Leaflet (PIL) | English & Malay |
| Official Correspondence (as needed) | English/Malay |
| Certificates/Supporting Documents | English* |
*If originally in another language, a certified English translation is required.
Key Points to Remember:
- Use English for all technical, scientific, and main Regulatory submission documentation.
- Ensure bilingual labelling and patient information materials.
- Translations must be accurate and, where required, certified.
Conclusion
Understanding Malaysia’s language requirements is essential for ensuring smooth NPRA submissions and avoiding compliance delays. From English-only technical dossiers to mandatory bilingual labeling, alignment with these standards is key to successful market entry.
Freyr supports pharmaceutical companies with end-to-end Regulatory documentation, translation readiness, and compliant ACTD submissions for the Malaysian market.