The new article describes in detail the procedure to be followed when applying for permission to conduct clinical trials in Pakistan.
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 and the way they should be conducted. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, so in case of any discrepancies with respective provisions of the underlying legislation, the latter should prevail. The authority also reserves the right to amend the guidance and recommendations provided therein, should it be necessary to reflect the respective changes in the applicable regulations. The scope of the guidance covers, inter alia, the procedure of applying for permission to conduct clinical trials.
Application for Clinical Trial: Key Points
According to the guidance, an application related to a Clinical Trial Site (CTS) should be filed either by a Principal Investigator (PI) or by Co-Principal Investigator (Co-PI); while an application for conducting a clinical trial in the country should be submitted by a Clinical Trials Sponsor or Principal Investigator. The document also provides contact details to be used to apply. It is also stated that there is a non-refundable fee to be paid for each application. The amount to be paid will be calculated on a case-by-case basis. The applicant will be able to generate the fee itself via the special tool provided by the authority. Then the said fee could be paid using the invoice that will be generated automatically.
The types of applications to be submitted include, inter alia, the following ones:
- Application for approval of Clinical Trial Site;
- Application for authorization of the conduct of a Clinical Trial;
- Application for Renewal of License of the Clinical Trial Site.
The forms to be used for the aforementioned applications could be downloaded from the authority’s official website. The should be filled in properly by the applicant and submitted in writing, accompanied by the necessary diagrams and drawings. The applications could also contain references to other documents related to the request, and all the documents should be submitted together. The applicant may also provide copies of the relevant publications to support the claims and statements made in the documents. However, the authority reserves the right to request additional information and data, should it be reasonably necessary to review the application. The authority also mentions that some of the documents, such as the protocol, investigator’s brochure, and reference publications could be provided in electronic format.
Under the general rule, all information should be provided in English, including all the data, supporting documentation, and labeling. Should any of the documents be initially issued in a language other than English, a certified translation should be duly provided as well.
The authority also mentions that it will take all the steps necessary to ensure the confidentiality of the documents submitted by the applicant.
Applications: Review and Approval
The document further describes the approach the authority applies when reviewing and approving the applications for clinical trials.
First of all, the authority will assess the completeness of the application received. Such a review will take up to 30 business days to be calculated from the date the application will be initially submitted by the applicant. At this stage, the authority will review the documentation and information provided to ensure it is sufficient to proceed with a review. Once the authority will confirm that the application is complete, and all the information is in place, it will proceed with the substantial review. At this stage, the application will be assigned with an application reference number to be used to identify the application in further interactions between the authority and the applicant.
The authority additionally emphasizes that in case the applicant becomes aware of any important information regarding the device – for instance, about adverse events associated with the product subject to review – such information should be communicated to the authority without undue delay. As was mentioned before, the authority is also entitled to request additional information to be provided.
During the next stage, the application would be subject to review by an expert to be designated by the authority. An expert will provide the comments the authority will take into consideration when making a regulatory decision. At this stage, the authority may also request additional information and data. As a result, an appropriate report will be generated.
The final decision regarding approving or rejecting the application for clinical trials will be taken by the Clinical Studies Committee (CSC). Apart from that, the protocol should be approved by the National Bioethics Committee. Once the decision will be taken, the applicant will be duly notified. In case of rejection, a detailed justification of the decision taken will be provided. In such a case, the applicant is also allowed to appeal against the decision taken.
The authority also mentions that when making a decision, it will also consider the information available about similar clinical trials. In particular, it is stated that any application for approval or registration of a clinical trial will not undergo the assessment process, if the same at any stage, has already been rejected, suspended, or put on hold due to any reason, in ICH member countries or stringent regulatory authorities and shall be rejected during the process of screening.
For the abovementioned rule, the following regulating authorities are considered to be reputable enough:
- The US Food and Drug Administration;
- The UK Medicines and Healthcare Products Regulatory Agency;
- The European Medicines Agency;
- Health Canada;
- The Therapeutic Goods Administration, Australia;
- Pharmaceutical & Medical Devices Agency, Japan.
In summary, the present DRAP guidance provides an overview of the current regulatory requirements related to applying for approval of clinical trials. The document describes in detail the way the application should be submitted and also outlines the scope of information to be provided by the applicant.
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