Pakistan’s clinical trial approval process is administered by the Drug Regulatory Authority of Pakistan (DRAP), the country’s national regulator for pharmaceuticals, biologicals, medical devices, and other health products. DRAP was established on November 12, 2012 under the DRAP Act 2012 as a self-governing federal authority, consolidating drug-regulatory functions that had previously been split across provincial and federal bodies. Clinical trial oversight sits within DRAP’s Division of Pharmacy Services, and the substantive rules governing how a trial is authorized, monitored, and registered are set out in the Bio-Study Rules, 2017 — the framework that gives DRAP’s clinical-trials mandate its legal teeth.
For sponsors and research institutions used to a single-agency model (as in the United States) or a single-portal model (as in India’s CDSCO pathway), the Pakistani system has a similar two-track structure: a national regulatory authorization from DRAP, running in parallel with independent ethics review, both of which must be in place before enrollment can begin.
The regulatory and legal framework
- DRAP Act, 2012 — the parent legislation establishing DRAP as Pakistan’s federal drug regulator, consolidating authority previously distributed across the Ministry of Health and provincial health departments.
- Bio-Study Rules, 2017 — notified by DRAP specifically to regulate clinical trial (bio-study) activity in Pakistan. These rules define what a clinical trial site license and a Clinical Trial Authorization (CTA) require, set out ethics-committee composition and function, and establish the national clinical trials registry.
- DRAP has also issued more detailed operational guidance building on the Bio-Study Rules — including published guidelines on the conduct of clinical research and on clinical trial site licensing — available on DRAP’s own site (dra.gov.pk). Sponsors and CROs should treat DRAP’s published guidance documents, not third-party summaries, as the current operative reference, since regulatory guidance is revised periodically.
Who reviews and approves a trial: the Clinical Studies Committee
Applications for a clinical trial site license and for authorization to conduct a specific clinical trial are submitted to the Clinical Studies Committee (CSC), which sits within DRAP’s Division of Pharmacy Services. The CSC’s role under the Bio-Study Rules is to evaluate whether a proposed trial adequately protects the rights, safety, and well-being of participants, and whether the trial is designed to generate reliable, robust data — the same core evaluative questions a national regulator asks anywhere, applied here through Pakistan’s own statutory process rather than a foreign one.
A trial cannot proceed on DRAP authorization alone. Independent ethics review is a separate, parallel requirement.
Ethics review: the IRB / IRC / ERC requirement
Rule 9 of the Bio-Study Rules, 2017 requires review by an independent ethics body — referred to interchangeably in Pakistani practice as an Institutional Review Board (IRB), Institutional Research Committee (IRC), or Ethics Review Committee (ERC) — composed of both medical professionals and non-medical (lay) members. This body’s function mirrors IRB/ethics-committee review anywhere: independently verifying that participant safety, integrity, and human rights are protected before a trial begins and throughout its conduct, separately from DRAP’s own regulatory assessment of the trial’s scientific and safety justification.
The Clinical Trials Registry
Rule 20 of the Bio-Study Rules obligates DRAP’s Division of Pharmacy Services to maintain a national Clinical Trials Registry covering approved trials involving human subjects conducted in Pakistan. DRAP operates this registry at ctr.dra.gov.pk. Registration in a recognized primary registry is consistent with the broader international norm — reflected in ICMJE policy and the WHO International Clinical Trials Registry Platform (ICTRP) network of primary registries — that a trial be registered in a public registry before or at the start of enrollment as a condition of later publication and public accountability. Sponsors running multi-country trials that include a Pakistani site should confirm whether DRAP’s registry participates in the WHO ICTRP network and plan dual registration (e.g., alongside ClinicalTrials.gov) accordingly, verifying current requirements directly with DRAP rather than assuming parity with other national registries.
What a sponsor should plan for
Because DRAP has not published a single, universally fixed statutory timeline or fee schedule that applies identically to every trial type on its public guidance pages, sponsors and research administrators should treat the following as a planning checklist rather than a fixed procedural script, and confirm current timelines, fees, and document checklists directly against DRAP’s own published guidance before submission:
- Site licensing. A clinical trial site typically needs its own DRAP license before it can host trial activity — a step distinct from, and generally required in addition to, authorization for the specific trial protocol.
- Clinical Trial Authorization (CTA). A written DRAP authorization for the specific protocol, submitted to the Secretary of the Clinical Studies Committee, is required before trial-related activity involving human subjects can begin at a given site.
- Parallel ethics approval. IRB/IRC/ERC review runs alongside — not sequentially after — DRAP’s regulatory review in most practical workflows, and both approvals need to be in hand before enrollment.
- Registry entry. The trial must be entered in DRAP’s Clinical Trials Registry once authorized, consistent with Rule 20.
- Import of investigational product. Importing an unregistered investigational drug, biologic, or device for trial use in Pakistan is a regulated activity in its own right, separate from trial authorization itself, and sponsors should confirm the applicable import/no-objection process directly with DRAP before shipping study supplies.
How this differs from India’s CDSCO pathway
Pakistan and India are both large South Asian markets with their own national drug regulators, but the two systems are not interchangeable, and sponsors running trials across both countries should not assume a single regulatory strategy applies to each. India’s Central Drugs Standard Control Organisation (CDSCO) operates under India’s New Drugs and Clinical Trials Rules, 2019, with its own timelines, ethics-committee registration regime, and its own trial registry (the Clinical Trials Registry – India, CTRI). DRAP’s authority derives from a distinct statute (the DRAP Act, 2012) and a distinct rule set (the Bio-Study Rules, 2017), administered through the Clinical Studies Committee rather than CDSCO’s structures. Treat each as a separate national submission requiring its own protocol package, ethics review, and registry entry — not a shared regional filing.
Not to be confused with: HEC Pakistan
Pakistan’s Higher Education Commission (HEC) is a research-funding and higher-education body, not a clinical-trial regulator — see CASRAI’s HEC Pakistan research funding overview. A Pakistan-based investigator or institution may need to engage both bodies on a given study (HEC for grant funding or academic research support, DRAP for regulatory authorization to actually conduct a clinical trial), but they are separate agencies with separate mandates, and neither substitutes for the other.
Frequently asked questions
Which body approves clinical trials in Pakistan?
DRAP (the Drug Regulatory Authority of Pakistan), specifically through its Clinical Studies Committee within the Division of Pharmacy Services, authorizes clinical trial sites and specific trial protocols under the Bio-Study Rules, 2017.
Is ethics committee approval required in addition to DRAP authorization?
Yes. Rule 9 of the Bio-Study Rules, 2017 requires independent review by an IRB/IRC/ERC composed of medical and non-medical members, running alongside DRAP’s own regulatory review — neither approval substitutes for the other.
Does Pakistan have its own clinical trial registry?
Yes. DRAP maintains the Clinical Trials Registry under Rule 20 of the Bio-Study Rules, 2017, operated at ctr.dra.gov.pk. Sponsors running multinational trials should confirm current dual-registration expectations (e.g., alongside ClinicalTrials.gov or the WHO ICTRP network) directly with DRAP.
Is DRAP the same as Pakistan’s HEC?
No. DRAP is the drug and clinical-trial regulator; HEC (the Higher Education Commission) is a research-funding and higher-education body. See CASRAI’s separate HEC Pakistan funding overview for that distinct topic.
What is the legal basis for DRAP’s clinical trial authority?
DRAP was created by the DRAP Act, 2012. Its clinical trial-specific authority is exercised through the Bio-Study Rules, 2017, which it notified under that Act.
DRAP publishes and periodically updates its own clinical-trial guidance directly at dra.gov.pk; sponsors and research administrators should confirm current fees, document checklists, and timelines against DRAP’s published guidance rather than third-party summaries before submitting an application.
