Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)

Overview

Good Clinical Practice (GCP) is an internationally recognised ethical and scientific quality standard for the design, conduct, documentation, and reporting of clinical trials involving human participants. Compliance with GCP is essential to protect the rights, safety, and well-being of trial participants, while ensuring the reliability and integrity of clinical trial data.
A GCP inspection is an official review of documents, facilities, records, and other resources related to the conduct of clinical trials. Inspections may occur during an ongoing clinical trial or after its completion. In some instances, for-cause inspections may be initiated in response to reports or concerns of serious non-compliance, such as data integrity issues or ethical/scientific misconduct.
NPRA GCP Inspections
In Malaysia, GCP inspections are primarily conducted by the National Pharmaceutical Regulatory Agency (NPRA), with additional oversight provided through compliance audits by the Medical Research and Ethics Committee (MREC). While NPRA typically conducts on-site inspections, remote inspections may be carried out when deemed necessary, especially in situations where on-site inspections are not feasible due to public health emergencies, travel restrictions, or other extraordinary circumstances.
Foreign regulatory authorities, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (USFDA), may also conduct inspections in Malaysia as part of the registration or marketing authorisation process for investigational products intended for their respective markets. NPRA inspectors may participate as observers or be involved in inter-agency joint inspections as part of international regulatory collaboration, as well as enhancing the transparency in global clinical research oversight of clinical trials.
The primary objective of GCP inspections is to verify compliance with regulatory and ethical standards, particularly those outlined in the Control of Drugs and Cosmetics Regulations 1984 and the Malaysian Guidelines for Good Clinical Practice (GCP). The Drug Control Authority (DCA) officially endorsed the Malaysian Guidelines for Good Clinical Practice Inspection at its 221st meeting on 29 October 2009, in accordance with Regulation 29 of the Control of Drugs and Cosmetics Regulations 1984. These guidelines establish a structured framework for the planning, execution, and reporting of GCP inspections in Malaysia.
In addition, NPRA has also expanded the scope of the GCP inspection to encompass Phase 1 Unit Inspection, creating a safe regulatory environment for the Phase 1 clinical trials in Malaysia. The Phase 1 Unit Inspection is designed to give assurance that the units listed in the NPRA Phase 1 Programme not only meet but surpass basic requirements under the Principles of GCP. TheMalaysian Guideline for Phase 1 Unit Inspection and Accreditation Programme was issued by the Director of Pharmaceutical Services under Regulation 29, CDCR 1984. Protocol Deviation
Protocol Deviation Submission

The Clinical Trial Import Licence (CTIL) or Clinical Trial Exemption (CTX) holder is responsible for reporting any updates or information relevant to the product or application, including protocol deviations. Detailed requirements are outlined in the Malaysian Guideline for Application for Clinical Trial Import Licence and Clinical Trial Exemption (refer to the List of Guidelines) Important Protocol Deviation: a subset of protocol deviations that may significantly impact the completeness, accuracy and/or reliability of the trial data or that may significantly affect a participant’s rights, safety or well-being. Minor Protocol Deviation:does not impact participant’s safety and data integrity but still requires documentation. Submission Requirements:

• Format: All protocol deviation submissions must be made electronically. Hard copy submissions will not be accepted.
• Cover Letter: Each submission must include a cover letter on the company’s official letterhead.
• Report File: The protocol deviation report must be submitted in Excel format and renamed using the relevant reference number.
• Template Compliance: Reports must follow the structure outlined in Form N3-FR-27: CTIL/CTX Protocol Deviation Report Template.
• Submission Email: All correspondence and submissions should be directed to mygcp@npra.gov.my.
• No Deviations: If no protocol deviations occur during the reporting period, notification to NPRA is not required.

Serious Breach

Serious Breach Submission

Serious Breach:Any deviation(s) from the approved clinical trial protocol, Principles of GCP, or any clinical trial-related regulations that is likely to have a significant impact on:

1. The safety, rights or well-being of any trial participants; or
2. The reliability and robustness of the data generated in the trial.

Submission Requirements:

• All serious breach submissions and correspondences must be made electronicallyto the Head of Good Clinical Practice and Good Laboratory Practice Sectionvia mygcp@npra.gov.my.
• Reporting Form: Please submit the serious breach report using this form N3-FR-82 Serious Breach Report, along with a cover letter on the company’s official letterhead.
• The Clinical Trial Import Licence (CTIL) or Clinical Trial Exemption (CTX) holder of the clinical trial is legally responsible for the reporting of serious breach to NPRA.
• All serious breaches should be reported without undue delay and at the latest within seven (7) calendar daysof the sponsor becoming aware of a serious breach. If the reporting responsibility is delegated to a contracted service provider such as a Contract Research Organisation (CRO), the 7-day timeline applies to the delegated party.
• Updates on the serious breach can be made whenever further information becomes available.
• If the investigation or corrective and preventive actions (CAPA) are ongoing at the time of reporting the serious breach, it is acceptable to outline the plans with projected timelines for completion. In such cases, the initial report should include an impact assessment and a summary of the root cause analysis.

• Please refer to the Frequently Asked Questions (FAQ) tab for information regarding the serious breach reporting process.

The Malaysian GLP Compliance Monitoring Authority

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environment safety studies are planned, performed, monitored, recorded, archived and reported. The purpose of the Principles of GLP is to promote the development of quality data.

The Principles of GLP should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetics products, veterinary drugs, medical devices as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms. The purpose of testing these items is to obtain data on their properties and/or their safety with respect to human health and/or the environment. Non-clinical health and environmental safety studies covered by the Principles of GLP include work conducted in laboratory, greenhouses, and in the field.

The National Pharmaceutical Regulatory Agency (NPRA) (previously known as National Pharmaceutical Control Bureau,NPCB) and Department of Standards Malaysia (DSM) had been appointed as the Malaysian Compliance Monitoring Authorities (CMAs) by the Malaysian Government. NPRA is the CMA for the non-clinical safety testing of test items contained in pharmaceutical products, cosmetics products, veterinary drugs, food additives and medical devices. Whereas DSM is the CMA for the non-clinical safety testing of test items contained in industrial chemicals, pesticides, feed additives, and biotechnology (non-pharmaceuticals). For NPRA, the decision by the Government of Malaysia is enforced by the issuance of a Directive under Regulation 29 of the Control of Drugs and Cosmetics Regulations 1984 in June 2009.

The GLP Compliance Programme (CP) is intended to ascertain whether test facilities have implemented requirements as described in documents of Organisation for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring. Test facilities requesting for verification and certification of compliance to Principles of GLP, and subsequent inclusion into the CMAs GLP Compliance Programme need to make the relevant application to CMAs.

There is a close cooperation between NPRA and the DSM. Joint inspections of test facility will be carried out together at the request of test facilities. If a test facility conducts studies that fall under the scope of NPRA and also studies which fall under the scope of DSM, a test facility may request a joint inspection by both CMAs by putting a parallel application to both CMAs for GLP Certification. In other occasions, NPRA may also invite inspectors from DSM to participate in their inspections from time to time and vice versa.

The NPRA GLP Compliance Programme includes pre-inspections, inspections, surveillance and extra-ordinary inspections. Pre-inspection is carried out for the first time to familiarize and verify that the test facility has the resources to undertake GLP studies in respect of management structure, physical layout of buildings and ranges of studies. The test facility inspections shall be a full inspection that involves both test facility and study audit (completed studies and/or on-going). Surveillance inspections will be conducted annually for the first two years and subsequent surveillance inspections in every two years at least three months from the date of the compliance certificate expires. Extra-ordinary inspection shall be carried out in situation not covered by pre-Inspections, inspections and surveillance inspections. Test facilities complying with requirements as described in documents of Organisation for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring shall be listed in the NPRA GLP Compliance Programme.

Effective from 29th March 2013, Malaysia is officially a non-member with full adherent to the Organisation for Economic Cooperation and Development (OECD) Council Acts related to Mutual Acceptance of Data (MAD) in the Assessment of Chemicals on Good Laboratory Practice (GLP). At present, thirty-eight (38) OECD countries and seven (7) non-member countries i.e. Argentina, Brazil, India, Malaysia, Singapore, South Africa and Thailand adhere to the system.

The GLP Compliance Programme will help our test facilities gain the acceptance of their non-clinical health safety studies into OECD countries and others members who adhere to OECD, thus reducing duplicative testing and shortening time-to-market for new products.

It will also provide assurance to both local and overseas regulators that the non-clinical studies from test facilities is a true reflection of the results obtained from the studies. With GLP recognition, health and environment non-clinical safety studies conducted locally will enjoy greater access to international market.

Currently, the NPRA GLP Compliance Programme is applicable only to test facilities located within Malaysia. Applications from foreign test facilities are not accepted at this time.

Beginning 1 January 2026, NPRA will also conduct study-specific GLP inspections at overseas test facilities to support product registration in Malaysia. Detailed information regarding these overseas inspections can be found here. Detailed information and condition regarding procedures under which test facilities inspections and study audits are performed can be found in the NPRA GLP Compliance Programme Manual.