Phase I Unit Inspection & Accreditation Programme

Phase I Unit Inspection & Accreditation Programme

Definition of Phase I Clinical Trial

Phase 1 clinical trial is the first stage in the clinical trial process to evaluate the safety, tolerability, and pharmacokinetics of a new drug or treatment in human subjects after preclinical testing. The primary objective of phase 1 clinical trials is to determine the maximum tolerable dose (MTD) or the recommended phase 2 dose (RP2D) of the drug or treatment.

Importance of First in Human Trials

First-in-human trials play a crucial role in the drug development process, providing valuable information that aids in developing new treatments, vaccines, and therapies for various diseases. These trials mark the first time a new drug or treatment is administered to humans, and they carry significant risks compared to other stages in clinical development. Typically conducted in healthy volunteers, the dose is gradually increased until the maximum tolerated dose is reached. The trial aims to determine the safety and tolerability of the drug or treatment in humans and to establish its pharmacokinetics and pharmacodynamics. Safety monitoring is a critical aspect of first-in-human trials, involving close observation of participants for adverse events and side effects.

Phase I Unit Inspection & Accreditation Programme

As part of the Malaysian Economic Transformation Program (ETP), which aims to boost economic growth through clinical research, the National Pharmaceutical Regulatory Agency (NPRA) has expanded the scope of its Good Clinical Practice (GCP) inspections to include Phase 1 Units. This initiative establishes a safe regulatory environment for conducting Phase I Clinical Trials in Malaysia.

The Phase I Unit inspection process is designed to ensure that these units meet high standards for preventing harm to clinical trial subjects and managing medical emergencies effectively. Beyond adhering to basic GCP requirements, units listed under the NPRA Phase I Program must implement additional best practices that uphold the highest standards for participant safety and emergency response.

This program provides assurance to sponsors that accredited units listed can significantly enhance volunteer safety and are recognized as centers of excellence for Phase I research. Phase I Units that comply with the Malaysian Guideline for Good Clinical Practice, the Malaysian Guideline for Phase I Unit Inspection and Accreditation Program, and all applicable regulatory requirements will be listed in the “National Pharmaceutical Regulatory Agency Phase I Unit Inspection and Accreditation Program.”


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