New Drug Product Registration

Expert management of New Chemical Entities (NCE), Biologics, and New Drug Products dossier submissions to the Drug Control Authority (DCA).

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Service Overview

Registering a New Drug Product or biological substance in Malaysia involves a complex evaluation process by the National Pharmaceutical Regulatory Agency (NPRA). Submissions must adhere to the ASEAN Common Technical Dossier (ACTD) or ICH Common Technical Document (CTD) standards.

ARCI provides end-to-end support, from gap analysis of clinical and non-clinical data to dossier compilation, submission, and correspondence with the ARCI provides end-to-end support, from gap analysis of clinical and non-clinical data to dossier compilation, submission, and correspondence with the NPRA to secure your product registration.

Who This Is For

  • Global pharmaceutical innovators.
  • Biotechnology firms.
  • Local representatives of foreign license holders.

Registration Process

1. Pre-Submission Strategy

Evaluations of dossier readiness and classification verification (Standard vs Priority Review).

2. Dossier Compilation

Structuring administrative, quality, non-clinical, and clinical data into compliant ACTD/CTD formats.

3. Monitoring & Response

Active monitoring of the evaluation status and expert drafting of responses to Quest3+ queries.

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

New Drug Registration FAQs

What is the standard timeline for New Drug approval? ▼
The NPRA client charter for full evaluation of New Drug Products is typically 245 working days, excluding stop-clock time for applicant queries.
What happens after approval? ▼
The registration of a product shall be valid for five (5) years or such period as specified in the Authority database (unless the registration is suspended or cancelled by the Authority). Any change to your registered product requires regulatory oversight. While Minor Variation Notifications (MiV-N) follow a simpler process, most modifications need NPRA approval before being enacted. We ensure your variation applications are prepared and submitted correctly, in full alignment with NPRA guidelines, to avoid delays and maintain compliance.