The new article describes in detail the regulatory approach to be followed when reviewing the applications related to clinical investigations to be conducted in Pakistan.
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The Drug Regulatory Authority of Pakistan (DRAP), the country’s agency in healthcare products, has published a guidance document dedicated to clinical research.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance to them.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
According to the guidance, the process for the review and approval of clinical trial applications is a structured and detailed procedure designed to ensure the safety, efficacy, and reliability of clinical research activities.
The present DRAP guidance delineates the key components and stages involved in the submission, review, and approval process.
Application Submission and Initial Screening
As explained by the authority, applicants must submit a complete application form along with supporting documentation, as specified in Forms I, II, IIA (Amended), and III of the Bio-Study Rules, 2017.
The Division of Pharmacy Services, DRAP, is responsible for screening applications within 30 working days for completeness.
This encompasses applications for licensing of Clinical Research Organizations (CROs), BA/BE Study Centers, Bio-Analytical Laboratories, or Clinical Trial Sites, as well as the registration of Clinical Trials or BA/BE Studies.
The aim is to ensure that applications are complete in their first submission to facilitate a smooth review process.
Review and Evaluation Process
The Pharmacy Services Division conducts a thorough review and evaluation of applications submitted by the interested parties.
Any observed shortcomings or the need for clarifications are communicated to the applicant through a letter of shortcoming.
Upon resolving these issues, the application is then forwarded to the Chairman of the CSC for the constitution of an inspection panel.
This panel conducts inspections and submits a report based on approved checklists, which are reviewed by the Pharmacy Services Division.
Subsequently, an agenda item is prepared for the CSC’s consideration and final decision. The entire process for Form-I applications is aimed to be completed within 90 working days from the receipt of the application.
Application Reference Number and Supplementary Information
Upon receipt of an application, an acknowledgment along with a reference number is issued, which should be used in all future correspondence.
Applicants are required to report any new information relevant to the product, such as adverse effects or changes in formulation.
Amendments to the trial, such as protocol changes or additional trial sites, must also be promptly communicated to the DRAP.
Expert Review and Approval
In accordance with the applicable legislation, technical documents and Summary Evaluation Reports are shared with CSC members or designated experts for technical evaluation.
The evaluation may lead to queries for the applicant, which should be addressed through the Pharmacy Services Division. Expert review reports are then compiled and discussed in CSC meetings for final decision-making.
The approval of clinical research applications hinges on completeness, adherence to guidelines, and prior approvals by ethical review committees.
Reliance on Decisions from Other Regulatory Authorities
The CSC considers clinical trial decisions, reports, or information from Stringent Regulatory Authorities (SRAs) and international bodies like WHO and ICH. Favorable decisions from these authorities can benefit the approval process.
However, any application previously rejected or suspended by these bodies will be automatically rejected during the screening process.
In general, the reliance approach is intended to streamline the regulatory processes and procedures while reducing the burden for applicants.
Import of Investigational Medicinal Products (IMPs)
Following approval for clinical research, applicants may apply for an import license for the investigational medicinal products required for the study.
The Quality Assurance and Lab Testing Division of DRAP handles the approval for importation under the Bio-Study Rules 2017. Import licenses have a two-year validity, with provisions for renewal if the clinical research extends beyond this period.
Post-Trial Review
According to the guidance, a Final Report/Clinical Study Report must be submitted to the DRAP for review upon completion of the clinical trial.
This post-trial review assesses the conduct and compliance of the clinical research with established guidelines and regulations.
Conclusion
In summary, the process outlined in the present guidance underscores the comprehensive and meticulous approach adopted by the DRAP when it comes to the review and approval of clinical trial applications. It emphasizes the importance of complete and accurate submission of applications, adherence to regulatory guidelines, and proactive communication of any amendments or new information related to the clinical trial. This structured framework ensures that clinical research is conducted in an appropriate way, also ensuring the accuracy and reliability of its results.
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