The article provides an overview of Pakistan’s regulatory framework for clinical trials and applications to be submitted by interested parties.
The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency responsible for healthcare products, has published a guidance document dedicated to clinical trial applications. The document is intended to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be considered by study sponsors, researchers, investigators, clinical research organizations (CRO), and other parties involved in clinical trials. In particular, the document describes the aspects associated with applying to conducting a clinical trial, and regulatory procedures associated thereto. The scope of the guidance covers the regulatory requirements to be followed, the procedure itself, and also the way the application will be reviewed, evaluated, and approved by the authority. Recommendations provided in the guidance are based on the Bio-Study Rules 2017, Drug Act 1976, and DRAP Act 2012. The authority additionally emphasizes that provisions of the guidance are non-binding, so in the case of any discrepancies with the provisions of the current legislation the latter should prevail. Furthermore, the DRAP is entitled to make changes to the guidance, should it be necessary to reflect the respective changes to the underlying regulations. The document constitutes the initial version of the guidance.
According to the Bio-Study Rules 2017, the DRAP is entitled to regulate and oversee the clinical trials conducted in Pakistan. This includes investigational studies involving human subjects (study participants) intended to collect clinical data raiding the product in question, especially in terms of its safety and performance (e.g., to assess clinical effectiveness or identify adverse reactions). The products that could be subject to the investigation include, inter alia, the ones that are registered in Pakistan, as well as unauthorized products. The present guidance provides recommendations to be considered when filing applications for clinical trials and describes the approach to be followed to accelerate and streamline the process. Under the general rule, it is required that all the therapeutic goods and health products used in Pakistan are registered with the Drug Regulatory Authority of Pakistan and any clinical trial using such registered or unregistered products must receive written approval from DRAP, under the Bio-Study Rules 2017 for that purpose.
As further explained by the authority, the approval itself does not release the applicant from ensuring compliance with any applicable regulatory requirements set forth under the existing regulatory framework. Moreover, the clinical trial application will be assessed separately from the application for marketing approval of the product itself, so even upon approval of the clinical trial application, a separate marketing approval would still be required.
As it was mentioned before, the DRAP is entitled to conduct oversight concerning medical devices and other healthcare products intended to be used in the context of clinical trials, including the aspects related to their safety and effectiveness. Once the approval for a clinical trial is granted, the authority issues a certificate that specifies the particular product covered.
Terms and Definitions
The document also provides definitions of the most important terms and concepts used in the context of clinical trials including, inter alia, the following ones:
- Audit – a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.
- Blinding/Masking – a procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
- Case Report Form (CRF) – a printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
- Clinical Trial Import License (CTIL) – a license issued by DRAP authorizing the licensee to import any registered or unregistered product for purposes of clinical trials.
- Clinical Trial/Study Report – a written description of a trial/study of any therapeutic, prophylactic, diagnostic agent conducted on human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.
Apart from defining the main terms in concepts, the guidance also describes the main phases of a medicine investigation process, since the scope of the guidance covers not only medical devices but drugs and biological products as well. According to the document, the main stages are:
- Phase I – the initial studies are conducted by engaging healthy volunteers to collect basic information about the safety of the product and the impact it causes.
- Phase II – a study involving a limited number of participants in a form of a placebo-controlled study to evaluate the actual therapeutic activity.
- Phase III – trials in larger (and possibly varied) patient groups to determine the short- and long-term safety/efficacy balance of formulation(s) of the active ingredient, and of assessing its overall and relative therapeutic value.
- Phase IV – is the only stage that takes place after placing the product in question on the market and making it available to healthcare professionals and patients. Usually, such trials are carried out in the course of post-market surveillance activities.
Roles and Responsibilities
The document further outlines the main roles and responsibilities of the parties involved in clinical trials and the approval process. According to the guidance,
- DRAP is responsible for ensuring the overall safety, quality, and effectiveness of healthcare products allowed for use in clinical trials to ensure the public health protection and the safety of the patients. As was mentioned before, any clinical studies cannot be carried out in Pakistan, unless a formal approval from the authority is granted.
- The study sponsor is responsible for all the aspects related to the trial and overall process. According to the applicable legislation, it is allowed to delegate some of the functions to third parties, however, the sponsor remains to be solely responsible for the outcomes of a study in general.
In summary, the present guidance provides an overview of existing regulatory requirements in the sphere of clinical trials. The document highlights the key aspects to be considered and also outlines the responsibilities of all the parties involved.
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