The new article provides additional details regarding the regulatory requirements for the importation of investigational products, as well as other aspects.
The Drug Regulatory Authority of Pakistan (DRAP), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical trials. The document describes the approach to be followed by the study sponsors when applying for approval for a planned clinical investigation. The guidance provides clarifications regarding the existing regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. However, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the respective amendments to the underlying legislation.
The document also states that any clinical trials should be followed by the appropriate reports to be submitted by the study sponsors to the authority.
Import of Investigational Medicinal Products
The scope of the guidance covers, inter alia, the aspects related to the import of investigational medicinal products (IMPs). As described in the guidance, once the initial application for clinical trials has been approved by the authority, the interested party may apply for an import permit. In such a case, the name and quantity of medicinal products to be imported should correspond to the products needed to conduct the appropriate clinical trials. According to the guidance, Form-4 should be filled in and submitted to the authority. The latter will review the request and if it meets all the conditions, a 2-year import license will be granted. In the case the intended duration of a corresponding clinical trial exceeds the said period, the sponsor may apply for an import license renewal.
The document also describes the non-routine procedures for clinical trials in a public health emergency. According to the applicable legislation, the situation of a public health emergency is defined as “an emergency need for health care [medical] services to respond to a disaster, a significant outbreak of an infectious disease, bioterrorist attack or another significant or catastrophic event”, routine procedures for clinical trial application may not be followed. It is further explained that the application for a clinical trial could be subject to review on a fast-track basis, should it be in the best public interest or public health emergency cases. Under the aforementioned fast-track procedure, the authority may waive certain requirements, e.g., the ones related to the documents to be submitted by the applicant, such as non-clinical data or labeling samples. Should the applicant be interested in applying for a clinical trial under the emergency pathway, it should duly notify the authority about such intent.
Flow and Timelines
The document also provides clarifications regarding the timelines and process flow for routine and non-routine clinical trial applications. As explained by the authority, the applications are processed under the “first-in, first-out” basis. Once the application has been received by the authority, it will be subject to the initial review which should last for 30 business days. Should any deficiencies be identified at this stage, the authority will notify the applicant accordingly. Once the deficiencies have been resolved, the application review process will commence from the very beginning. Upon completion of the review, the authority will notify the applicant within 10-15 business days about the decision taken.
As was mentioned before, in case of public health emergencies, a fast-track procedure could be applied. According to the said procedure, the application review should take up to 7 business days or less, if this will be feasible. The decision taken by the authority will be communicated to the applicant within 7 business days.
According to the guidance, the whole review process is comprised of the following steps:
- Receipt of Clinical Study Application to Division of Pharmacy Services;
- Initial scrutiny/evaluation (within 30 working days),
- In case pre-requisites for application are incomplete, shortcomings communicated to the applicant within 5-10 working days,
- Receipt of reply regarding shortcoming from the applicant (then the whole process starts from the step 1);
- In case pre-requisites for application are complete, the application should be forwarded to Chairman CSC for approval as an agenda item for the CSC meeting;
- Complete applications placed before CSC in its forthcoming meeting;
- After consideration of CSC & finalization of minutes, License/Registration letters, or decisions issued (within 10-15 working days).
Ethical Approval of the Clinical Trial
According to the applicable regulatory requirements, and ethical clearance certificate should be included in the clinical trial application. As described in the document, ethical approval of the Clinical Trial / Studies Protocol, Protocol Amendments, and the methods and materials to be used in obtaining and documenting informed consent of the trial subjects, is required to be sought from Institutional Review Committee (IRC) or Institutional Review Board (IRB), and National Bioethics Committee (NBC).
The document further describes the scope of responsibilities of the said bodies, their goals, structure, and functions.
Amendments and Urgent Safety Measures
The document also highlights the matters related to the amendments to the protocol of clinical trials already approved by the authority and the way they can be implemented without obtaining prior approval. According to the guidance, should the changes introduced be substantial, the entire application should be withdrawn and the new (amended) version should be submitted instead. The authority also states that the protocol should meet the applicable regulatory requirements, as well as recommendations provided in the respective guidelines issued by the said agencies.
However, should the amendments to the clinical trial protocol be intended to ensure the safety of study participants, such amendments could be implemented immediately, while the study sponsor will have to notify the authority about the amendments within 48 hours from the moment they have been implemented. At the same time, all the amendments impacting the safety of study participants should be subject to prior approval, unless the immediate implementation is reasonably necessary due to the nature of such amendments.
In summary, the present document describes the approach to be followed when applying for an import license for the products to be used in clinical trials, provides clarifications regarding the timelines, and explains the whole application process step-by-step. The document also provides additional details regarding the ethical approval and the way it should be obtained in case of changes to the protocol of the clinical trial already approved by the authority.
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