##  [What are the Language Requirements for Pharmaceutical Regulatory Submissions in Malaysia?](/index%2ephp/what-are-the-language-requirements-for-pharmaceutical-regulatory-submissions-in-malaysia) 

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## Regulatory Authority:

The [National Pharmaceutical Regulatory Agency](https://www.freyrsolutions.com/what-is-the-national-pharmaceutical-regulatory-agency-npra-in-malaysia) (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](https://www.freyrsolutions.com.my/pharmaceutical-product-registration-in-malaysia) 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)](https://www.freyrsolutions.com/blog/drug-registration-malaysia-6-key-steps-to-prepare-a-compliant-npra-submission-dossier) 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.