NPRA Product Registration: Translating Documents and Labels
Short answer: NPRA's Drug Registration Guidance Document (3rd edition, 12th revision, July 2026) says: "All data and information including supporting documents for product registration such as certificates, letters and product labels shall be in English or Bahasa Malaysia." A CPP or GMP certificate issued in Chinese, Korean or Japanese therefore needs an English translation. Labels and package inserts must be in Bahasa Malaysia or English, with other languages allowed in addition; "Keep medicine out of reach of children" must appear in both; and the consumer leaflet (RiMUP) is submitted "in both English and Bahasa Malaysia". Cosmetic labels must be in Bahasa Malaysia and/or English. NPRA's own letters and GMP reports are usually in Malay, and its GMP section "only accepts translations performed by an authorized / professional translator or translation body", verified through form BPFK-505.
What we do: English translations of foreign CPPs, GMP certificates, manufacturing licences and letters for NPRA dossiers; Malay translations of labels, package inserts and RiMUP; and English translations of NPRA letters and GMP inspection reports for submission on form BPFK-505. Our team is certified by ITBM, DBP and the Malaysian Translators Association, includes Kuala Lumpur and Sarawak High Court interpreters and NAATI-certified translators, and works with Notaries Public in Malaysia, Singapore and Australia. Send the documents on WhatsApp for a quote.
Last reviewed: October 2026.
Documents coming in: foreign certificates for registration
Language: certificates, letters and labels must be in English or Malay (DRGD section 7.13).
CPPs: "Both original and electronic CPPs issued by the NRAs are acceptable", but a "CPP issued by the manufacturer is not acceptable" (Appendix 29).
OTC products, health supplements and some natural products need a CFS and GMP certificate "from the relevant competent authorities".
Typical translations: Chinese, Korean, Japanese, Thai, Vietnamese and European-language CPPs, GMP certificates, manufacturing licences, letters of authorisation and stability or batch certificates.
Labels, package inserts and RiMUP
Labels and package inserts: "must be in Bahasa Malaysia or English", and translation into another language is allowed in addition (Appendix 19).
Mandatory bilingual phrase: "Keep medicine out of reach of children" in both Bahasa Malaysia and English.
RiMUP: the draft "in both English and Bahasa Malaysia shall be submitted for evaluation" (section 7.11(b)).
Cosmetics: label information "shall be in Bahasa Malaysia and/or English", and the product information file "shall be in Bahasa Malaysia or English".
A RiMUP is read by patients, so its Malay must be plain and consistent with the approved English text and the package insert.
Documents going out: translating NPRA's Malay documents
NPRA says its official documents "are usually in national language". When a foreign partner, regulator or auditor needs a GMP inspection report or an NPRA letter in English, NPRA's GMP section accepts translations only from an authorised or professional translator or translation body, submitted "for verification and endorsement" with form BPFK-505. We prepare those translations with the translator's details NPRA needs.
How we work on NPRA files
Send the documents and the product type (pharmaceutical, health supplement, natural product or cosmetic).
We translate with a pharmaceutical glossary, keeping product names, strengths, batch numbers and dates exactly as in the source.
We check numbers, units and regulatory terms against the source.
You receive the translation with a signed translator's certificate, ready to upload to QUEST3+ or submit with BPFK-505.
Maklumat dalam Bahasa Melayu
Garis Panduan Pendaftaran Ubat (DRGD) NPRA menetapkan semua data dan dokumen sokongan, termasuk sijil, surat dan label produk, hendaklah dalam bahasa Inggeris atau Bahasa Melayu. RiMUP mesti dikemukakan dalam kedua-dua bahasa, dan amaran supaya ubat dijauhkan daripada kanak-kanak mesti dicetak dalam Bahasa Melayu dan Inggeris. Terjemahan dokumen rasmi NPRA hanya diterima daripada penterjemah atau badan terjemahan profesional melalui borang BPFK-505. Kami menyediakan terjemahan ini. WhatsApp: +60 17-227 9378.
中文说明
马来西亚药品管理局（NPRA）规定，产品注册的所有资料和证明文件，包括证书、信函和标签，必须为英文或马来文。中文、韩文或日文的药品证明（CPP）及GMP证书须附英文翻译；患者用药说明（RiMUP）须同时提交英文和马来文版本。我们提供药品注册文件及标签翻译。WhatsApp：+60 17-227 9378。
Common questions
Does NPRA require certified translations of foreign certificates?
The DRGD requires documents in English or Malay but does not set a translation format. A translation with a signed translator's certificate is the safe choice. For translations of NPRA's own documents, the GMP section accepts only authorised or professional translators.
Can product labels be only in English?
Yes, labels and package inserts may be in Bahasa Malaysia or English, but "Keep medicine out of reach of children" must appear in both languages, and the RiMUP must be submitted in both.
Do I need a consultant to register on QUEST3+?
NPRA says registering for QUEST3+ "is straightforward, and you do not need to hire a regulatory consultant or agent". You need a USB token from MSC Trustgate.
Do you translate cosmetic labels?
Yes. Cosmetic labels must be in Bahasa Malaysia and/or English; we translate them and the product information file.
Related guides
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