The article highlights the critical points associated with clinical practice inspections in Pakistan.
Table of content
The Drug Regulatory Authority of Pakistan (DRAP), the country’s regulating agency in healthcare products, has published a guidance document dedicated to conducting and reporting good clinical practice inspections.
The document provides an overview of the applicable regulatory requirements and additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance with them.
The authority also reserves the right to change the guidelines and recommendations provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the document describes the critical aspects of the inspections, including their purpose and types.
Also, it highlights the primary considerations to be taken into account by the parties involved to ensure the requirements set forth by the relevant legislation are followed to the letter.
Application of Guidelines
The present guidelines are addressed for individuals and organizations involved in clinical research concerning therapeutic goods.
This covers a wide range of stakeholders, including Sponsors, Principal Investigators (PI), Site Investigators (SI), Contract Research Organizations (CROs), Clinical Trial Sites, BA/BE Study Centers, and Bio-Analytical Laboratories.
Additionally, they serve as a procedural guide for CSC-nominated experts, Clinical Research Evaluators/Assessors and the GCP inspectorate under the Drug Regulatory Authority of Pakistan to standardize the conduct and reporting of GCP inspections in the context of clinical research related to therapeutic goods, including medical devices intended to be marketed and used in the country.
Purpose and Introduction
As stated by the authority, the primary aim of the document is to provide comprehensive guidance to entities engaged in clinical research, highlighting regulatory mandates for conducting and reporting GCP inspections.
These guidelines align with the Bio-Study Rules of 2017, ensuring that all therapeutic goods and health products used in Pakistan receive proper registration or listing with DRAP.
The document also stipulates the need for written approval for clinical trials, emphasizing the DRAP’s authority to monitor and inspect research sites to enforce best practices and ensure adherence to ethical and regulatory standards.
Inspection Basis and Criteria
According to the existing legislation, GCP inspections are crucial for safeguarding study subjects’ rights and ensuring data integrity.
These inspections are subject to various criteria, including the trial phase, nature of the intervention, involvement of vulnerable populations, and risk assessments conducted by the CSC-DRAP.
Factors such as multi-centre study size, reported deviations, adverse drug reactions (ADRs), and complaints can also influence the selection of sites for GCP inspection.
Objectives and Nature of GCP Inspections
The DRAP may initiate GCP inspections under several circumstances, among other things, such as verifying trial accuracy, investigating complaints, assessing ongoing research, monitoring adverse event reporting, and evaluating investigational product handling.
Inspections can be protocol-specific, focusing on the trial/research protocol’s compliance with GCP standards, or system-specific, examining clinical trial/research systems like informed consent processes and pharmacovigilance.
Ensuring Compliance and Integrity in Clinical Research
The guidelines emphasize the critical role of GCP inspections in maintaining the integrity of clinical research in Pakistan. Through detailed procedural guidance, these regulations are intended to facilitate compliance with the relevant ethical principles, GCP guidelines, and regulatory requirements set forth under the existing legal framework, ensuring the protection of participants and the credibility of clinical research data.
Conclusion
By the present document, the authority intends to provide a comprehensive overview of the relevant regulatory requirements the parties involved should follow.
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