Generic Product Registration

Accelerating market access for Generics (scheduled poisons) and OTC (non-scheduled poisons) through precise regulatory planning and compliant dossier compilation.

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Service Overview

Generic medicines play a vital role in Malaysia's healthcare system. Registration requires proving that the generic product is essentially similar to the innovator product. The NPRA evaluates quality, safety, efficacy including Bioequivalence (BE) where applicable.

ARCI helps generic manufacturers and importers navigate the specific requirements for Scheduled Poisons (Group B & C) and OTC (non-scheduled poisons) products, ensuring all relevant documentation standards are met.

Who This Is For

  • Generic drug manufacturers.
  • Pharmaceutical importers/distributors.
  • Contract Manufacturing Organizations (CMOs).

Key Considerations

Bioequivalence (BE)

Guidance on BE study protocols and reports for oral solid dosage forms to prove equivalence.

GMP Compliance

Ensuring overseas manufacturing sites are GMP compliant and acceptable to the NPRA.

Abbreviated Review

Strategic use of Abbreviated Review pathways for certain eligible generic categories.

4. Pharmacovigilance (PV) Support

Advisory and operational support to Product Registration Holders (PRH) in meeting pharmacovigilance obligations, including:

  • Adverse Drug Reaction (ADR) Reporting
  • Risk Management Plan (RMP) Support
  • Product Recall Management

Generic Registration FAQs

How long is the evaluation for generics? ▼
Full evaluation typically takes 210 working days. Abridged evaluation (only for non-scheduled poisons) can be faster, around 116 - 136 working days.
What is the core document required for registration? ▼
The foundation of your submission is a complete registration dossier, which must be prepared in the required ICH CTD or ASEAN CTD format.
What manufacturing and quality compliance documents are needed? ▼
You must provide:
  • GMP Certificates: Valid certificates from the manufacturer (NPRA-issued for local sites; PIC/S authority certificate or NPRA inspection for international sites).
  • API Information: Drug Master File (DMF), CEP Certificate, or full details within the dossier.
  • CPP Certificate: A WHO-format Certificate of Pharmaceutical Product for imported goods.
What specific data and validation reports are required? ▼
  • Stability Data: Minimum 12 months of Zone IVB real-time stability data (30°C/75% RH).
  • Validation Reports: Process Validation report (typically 3 commercial batches) and Analytical Method Validation report.
When is a Bioequivalence (BE) Study required? ▼
A BE study is mandatory for generic oral solid dosage forms. It must be conducted at an NPRA-accredited or accepted center and include a complete report with clinical, bioanalytical, PK, and statistical data.