On May 16, 2025, Pakistan’s Drug Regulatory Authority (DRAP) published the third edition of its Guidelines for the Conduct and Reporting of GCP Inspections, offering a more structured, risk-based, and globally harmonized framework for evaluating clinical trials.
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This release marks a strategic evolution toward aligning with international best practices, such as ICH E6(R2/R3), and reinforces Pakistan’s regulatory credibility in global research.
For sponsors, CROs, investigators, and associated entities, this updated guidance offers both clarity and a call to action. Below is a comprehensive breakdown of what’s new, what matters, and how to prepare.
Who Needs to Comply? Expanding the Scope of Applicability
The updated guidelines extend DRAP’s inspection scope beyond traditional clinical trial sites to encompass a broader network of stakeholders. These include sponsors of clinical research, principal and sub-investigators, contract research organizations (CROs), bioavailability/bioequivalence (BA/BE) study centers, and bio-analytical laboratories.
This expanded reach reflects the increasingly decentralized and outsourced nature of modern clinical trials, where critical activities like data analysis, investigational product handling, and subject safety oversight may occur outside the physical trial site. If your organization performs any function tied to trial conduct, regulatory documentation, or subject safety in Pakistan, it is likely subject to inspection under the 2025 framework.
A Risk-Based Strategy: Prioritizing Inspections with Purpose
In line with ICH E6(R2/R3) principles, DRAP now employs a risk-based model to prioritize which entities are inspected and when. Factors influencing selection include the inherent risk of the investigational product (e.g., novel biologics or gene therapies), trial complexity (multi-arm, adaptive designs), population vulnerability (e.g., pediatric, terminally ill), and historical performance of a site or CRO.
Additionally, past regulatory findings, unresolved complaints, and even signals from ongoing safety reporting can trigger inspections. This tiered approach allows DRAP to focus its inspection resources where potential non-compliance could have the highest impact on subject safety or data integrity.
For sponsors and CROs, this underscores the importance of robust risk assessment, quality management systems, and early identification of performance outliers well before DRAP steps in.
Inspector Expertise: Qualified Eyes on Compliance
The updated guidelines emphasize the qualifications, training, and competencies required for GCP inspectors. Inspectors are expected to possess a deep understanding of both ICH GCP standards and national regulations, coupled with hands-on experience in clinical trial oversight.
Beyond theoretical knowledge, inspectors must demonstrate the ability to assess complex trial systems, verify data integrity across decentralized processes, and evaluate the effectiveness of sponsor oversight. Their skill sets must also include detailed documentation analysis and the ability to conduct investigative interviews that elicit reliable insights into trial conduct.
This elevated bar signals that inspections are no longer mere box-checking exercises, they’re comprehensive audits led by professionals trained to identify systemic issues.
Inspection Process: What to Expect When DRAP Visits
A DRAP GCP inspection follows a structured, transparent approach designed to evaluate every critical component of trial conduct. The process typically begins with a review of ethics committee approvals and informed consent documentation, confirming that subject rights were adequately protected from the outset.
Inspectors will then examine:
- The Trial Master File (TMF) and Investigator Site File (ISF)
- Cross-verify source data with Case Report Forms (CRFs)
- And evaluate documentation related to adverse events (AEs) and serious adverse events (SAEs)
Special attention is paid to investigational product handling (storage conditions, temperature logs, dispensing records) and how deviations are documented and managed. Personnel interviews are also standard, often focusing on training adequacy, delegation of trial responsibilities, and the site’s familiarity with trial protocols and regulatory obligations.
For international sponsors, especially those operating via CROs or third-party labs, it’s crucial to ensure that quality documentation is complete, centralized, and inspection-ready.
Post-Inspection Reporting & CAPA Expectations
Following an inspection, DRAP issues a detailed report that categorizes findings based on their severity, typically as critical, major, or minor. Sponsors or responsible parties must respond by developing a Corrective and Preventive Action (CAPA) plan that addresses the root causes of deficiencies.
These CAPA plans should be well-structured, including timelines, designated responsible persons, and preventive strategies that address systemic vulnerabilities. DRAP reviews these submissions carefully and may conduct follow-up inspections to verify that commitments have been fulfilled.
Failure to implement effective CAPA plans could result in escalated enforcement, including restrictions on trial activity or license revocation. That makes proactive planning, documentation, and real-time issue resolution non-negotiable elements of any trial team’s SOP.
Global Implications and the Role of RegDesk
As Pakistan continues to grow as a destination for clinical research, regulatory transparency and oversight rigor are essential. DRAP’s 2025 guidelines demonstrate its intent to integrate more fully with global regulatory expectations, therefore, enhancing sponsor confidence and trial data credibility.
For global sponsors navigating multi-country trials, tools like RegDesk provide critical infrastructure to streamline compliance.
RegDesk’s platform can help:
- Centralize and automate documentation tracking (e.g., TMFs, ethics approvals, AE reports)
- Monitor compliance indicators and detect potential inspection triggers early
- Manage CAPA plans across sites with real-time progress updates
- Ensure alignment with other global standards (FDA, EMA, CDSCO) to reduce redundancy
Conclusion
The 3rd edition of DRAP’s GCP Inspection Guidelines marks a significant milestone in Pakistan’s regulatory landscape. With a more expansive scope, risk-prioritized site selection, elevated inspector qualifications, and stricter follow-up expectations, stakeholders must embrace a culture of continuous readiness.
Organizations that treat compliance as a dynamic, systems-driven function supported by digital tools like RegDesk will not only meet inspection requirements but thrive under them.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System (RIMS) designed to simplify global compliance for medical device companies. With regulatory intelligence covering 120+ markets, RegDesk helps you prepare and publish global submissions, manage standards, conduct impact assessments, and stay ahead of regulatory changes all from a single, centralized platform. Expanding into new markets has never been easier.
