Clinical Trials

Last Updated on July 5, 2022

The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules, 2017.

What are Clinical Trials?

A clinical trial is a research study of therapeutic products in human to investigate any of the following:-

-To discover or verify the clinical, pharmacological, or other pharmacodynamic effects of an investigational product

-To identify any adverse reactions to an investigational product, (i.e. Phase I to Phase IV studies)

–To study absorption, distribution, metabolism and excretion of an investigational product with the object of ascertaining its safety and efficacy.

What is an Investigational Product?

Investigational products are experimental therapeutic goods with any type of active substance, including pharmaceutical, biological, herbal and homeopathic products, medical devices, etc, , or may be a registered drug or enlisted product, or a placebo. Authorized products (registered / enlisted) may be used in accordance with the terms of the registration or enlistment as applicable, or used in a different way, e.g., at a higher dose, for a new indication or when packaged in a different container closure system.

Regulation of Clinical Trials

The conduction of clinical trials in Pakistan is subjected to various regulatory control to ensure the safety of participants, and to ensure that experimental design of clinical study is appropriate to obtain valid data without exposing participants to unnecessary risks. Drug Regulatory Authority of Pakistan (DRAP) is mandated to regulate the clinical trials and to implement international recognized standards as adopted by the World Health Organization and International Conference on Harmonization. The Authority with approval of Federal Government, has notified the Bio-study Rules, 2017 for regulation of the clinical trials activities in the country.

Clinical Studies Committee (CSC)

The regulatory oversight is mandated to Clinical Studies Committee (CSC) under the Bio-Study Rules, 2017. The CSC is responsible to assess that rights, safety and well-being of trial participants is protected before start of clinical trials, and data generated will be reliable and robust. This committee reviews the clinical studies protocols and monitor the compliance to Good Clinical Practices (GCP) for conduction of clinical trial and can cause inspections of clinical trial site and CROs.

In addition to CSC, Division of Pharmacy Services, Division of Quality Assurance & Lab Testing, and National Bioethics Committee of Pakistan are also involved in regulatory oversight of various activities of clinical trials.

Authorization for Conduct of Clinical Trials

The application for approval of Clinical Trial Site(s) (CTS) should be from the Principal Investigator (PI) or Co-Principal Investigator (Co-PI) working at the applied site. Whereas for Clinical Trials Sponsor or the Principal investigator of the study may apply to seek authorization to conduct a clinical trial in Pakistan. Application for approval of Clinical trial site and conduct of clinical trials are required to be submitted to the Secretary, Clinical Studies Committee, Division of Pharmacy Services, DRAP.

DRAP has also published a Guidance on Clinical Trials Application to assist applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions and to explain the regulatory requirements to be fulfilled during the clinical trials. This Guidance document also explain the procedure for submission, review, evaluation and approval of applications for the conduct of clinical trials. In addition, Applications Forms and checklists to fill out the requirements and documentations to be submitted by the applicants for clinical trials are also available on our website .

Ethical Approval of Clinical Trials

National Bioethics Committee is a notified body on bioethics working under Ministry of National Health Services, Regulation and coordination. NBC is mandated to uphold bioethical principal in all sectors of healthcare in the country. All application for authorization of conduction of clinical trials are required to seek prior approval from the National Bioethical Committee under the Rules 9 of Bio-Study Rules, 2017. The primary scope of information assessed by the NBC relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their
participation in a clinical trial, in accordance with the requirements set forth in the Declaration of Helsinki. NBC also assess the scientific basis and ethics of clinical trials, qualifications of researchers, and other relevant consideration to the corresponding ethical issues, laws, and regulations

Flow Charts
1. Grant of License to act as Contract Research Organization, Clinical Trial Site, BA/BE Studies Center & Bio analytical Lab.

2. Renewal of License to act as Contract Research Organization, Clinical Trial Site, BA/BE Studies Center & Bio analytical Lab

3. Grant of Registration to conduct Clinical Trial Studies or Bioavailability /Bio Equivalence Studies