Guidelines Related to BEEC Inspection
This page serves as a consolidated reference for guidelines related to bioequivalence studies, bioequivalence centres and ethics committee oversight under the scope of the Bioequivalence Centre & Ethics Committee Section. It is intended to assist stakeholders in identifying current guidance documents issued or recognised by NPRA for regulatory reference, operational use and inspection preparedness. For regulatory compliance purposes, users are advised to refer to the most recent and applicable guideline.
Please select the relevant tab below to view the applicable documents.
Click on the document title to access a brief description and the hyperlink to the published document.
+ Malaysian Guideline for BE Inspection
This guideline explains the overall framework used by NPRA for bioequivalence inspection activities. It helps applicants and BE centres understand the inspection process, the main areas that may be reviewed, and the expectations for demonstrating compliance. It also serves as a practical reference for preparation before, during and after inspection.
- View / Download Second Edition [latest published edition]
- Public consultation: 8 April 2024 - 6 May 2024 [CLOSED]
+ Malaysian Guideline for Application of CTIL and CTX
This guideline describes the requirements and process for applications involving CTIL and CTX in Malaysia. It helps applicants understand the regulatory pathway, the supporting information expected by NPRA, and the obligations that apply to trial-related submissions. It is intended to promote complete applications and smoother regulatory review.
+ Application Manual for the Evaluation on the Need for Bioequivalence Study Inspection (BEDE)
This manual explains the process for requesting NPRA’s assessment on whether a bioequivalence study requires inspection. It guides applicants on submission flow, required documents and administrative steps for BEDE-related applications. It is intended to support more standardised submissions and more efficient screening and evaluation.
+ Malaysian Guideline for Good Clinical Practice
This guideline sets out the core principles and expectations for the ethical and scientific conduct of clinical trials in Malaysia. It is intended to protect trial participants while supporting the generation of credible and reliable clinical data. It serves as a foundational reference for investigators, sponsors, ethics committees and regulators involved in clinical research.
+ Malaysian Guideline for Good Clinical Practice (GCP) Inspection
This guideline provides the reference framework for the planning, conduct and reporting of GCP inspections in Malaysia. It helps inspection parties understand the scope of review, the inspection approach and the expectations for compliance with GCP-related requirements. It also promotes consistency and transparency in how GCP inspections are carried out.
+ Malaysian Guideline for Independent Ethics Committee Registration and Inspection
This guideline explains the requirements for registration and inspection of Independent Ethics Committees within NPRA’s regulatory scope. It helps ethics committees understand the standards, documentation and inspection considerations relevant to their oversight role. It is intended to strengthen the quality and consistency of ethics review and related compliance activities.
Last updated: 26 March 2026
+ FAQs for ASEAN MRA for Bioequivalence Study Reports [external link]
This document provides frequently asked questions on the ASEAN Mutual Recognition Arrangement for Bioequivalence Study Reports. It is intended to clarify key concepts, processes and practical issues relating to implementation of the ASEAN MRA for applicants and other stakeholders. It also serves as a quick reference to support a more consistent understanding of the ASEAN MRA framework.
+ Procedures and Manual of Joint Sectoral Committee (JSC) and Annexes [external link - ASEAN website]
This document provides the procedural framework and operational guidance for the Joint Sectoral Committee under the ASEAN Mutual Recognition Arrangement for Bioequivalence Study Reports. It explains the roles, responsibilities and processes used in coordinating implementation and decision-making among ASEAN Member States. It also serves as a reference for the annexes and supporting procedures applied under the ASEAN MRA framework.
+ Operation Manual of the Panel of Experts (PoE) and Annexes [external link - ASEAN website]
This manual sets out the operational guidance for the Panel of Experts involved in the ASEAN MRA for Bioequivalence Study Reports. It outlines the technical review processes, roles and responsibilities of the Panel of Experts, and the relevant annexes supporting its work. It is intended to promote consistent, transparent and efficient expert evaluation within the ASEAN framework.
+ Manual for Application of Bioequivalence (BE) Centre to be listed under ASEAN MRA BE and Annexes [external link - ASEAN website]
This manual explains the application process for a Bioequivalence Centre seeking listing under the ASEAN MRA for Bioequivalence Study Reports. It describes the submission requirements, assessment flow and supporting annexes relevant to the listing process. It serves as a practical guide for BE centres preparing applications and for stakeholders involved in evaluation under the ASEAN arrangement.
Original documents can be accessed at: https://asean.org/our-communities/economic-community/standard-and-conformance/
Key Documents and Publications > Policy & Guidelines > 8. Pharmaceutical Product Working Group (PPWG)
Last updated: 26 March 2026