The new article highlights the aspects related to approvals for clinical trials, as well as pharmacovigilance practices.
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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 the application of reliance mechanisms in regulatory processes and Good Reliance Practice. The document is intended to provide additional clarifications regarding the approach the authority intends to apply when relying on regulatory decisions taken by other national regulating authorities with respect to healthcare products intended to be marketed and used in the country. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
According to the guidance, the reliance approach is intended to streamline and facilitate the regulatory procedures associated with placing new healthcare products on the market by reducing the regulatory burden for all the parties involved. When applying the respective mechanisms, the authority relies on the decision taken by a trusted foreign national regulatory agency with respect to a medical device in question.
The scope of the document covers, inter alia, the aspects related to the application of the reliance approach to specific areas, such as clinical trials or pharmacovigilance activities.
Clinical Trials Approval
Under the general rule, the requirements for clinical trials are set forth by the Bio-study Rules 2017, according to which the Clinical Study Committee (CSC) is authorized to grant approvals necessary to conduct clinical investigations in the country. The aforementioned regulation also contains special provisions related to the application of the reliance mechanism, namely:
- In accordance with sub-rule 08 of Rule 13, “The CSC shall also consider relevant clinical trial decisions, reports or other information from stringent regulatory authorities and regional or international bodies like WHO, ICH, and others. Any application for approval or registration of clinical trial will not undergo in 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”.
- Furthermore, Rule 12(1) of the said Rules states that an interested party is obliged to review and communicate to the Commission all the information relevant to risk-benefit assessment, as well as the safety of a healthcare product subject to investigation, which becomes available to such party from any source. As explained by the authority, this applies to information derived from any clinical or epidemiological investigations, animal investigations, commercial marketing experience, reports in the scientific literature, and unpublished scientific papers, as well as reports from foreign regulatory authorities that have not already been previously reported to the DRAP”.
According to the guidance, the general list of reference regulatory authorities should be applied with respect to the matters related to clinical investigations and approval thereof. The authority additionally emphasizes that in case a clinical trial has been rejected, suspended, or put on hold for any reason and at any stage by a foreign national regulating authority, it will not be considered for assessment.
The document further outlines the elements of a reliance mechanism applied with respect to clinical trials. According to the guidance they include the following:
- Review of approval or rejection of clinical trials in reference to regulatory authorities;
- In case information is not available on the official website, the reference regulatory authority is contacted directly via electronic mail for a query or clarification on a particular issue under consideration;
- Regulatory status or any other regulatory information available in the public domain through their website;
- Reports in the scientific literature, and unpublished scientific papers, as well as reports from foreign regulatory authorities.
Pharmacovigilance Activities
The scope of the guidance also covers the regulatory aspects related to pharmacovigilance activities subject to regulation under the Pharmacovigilance Rules 2022. The latter empowers the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) to conduct continuous monitoring of adverse events and incidents associated with healthcare products, as well as the assessment of the respective data.
When applying the reliance approach, the PRAEC may consider or recognize and if deemed appropriate shall implement within Pakistan, the pharmacovigilance relevant decisions of other countries and of regional and international bodies. As further explained by the authority, the aforementioned approach applies with respect to the decisions related to:
- Changes to the indications based on safety concerns;
- Addition of new contraindications;
- Initiation of additional post-marketing studies based on safety reasons;
- Significant changes to warnings and precautions;
- Special actions taken with respect to the products placed on the market in other countries, such as withdrawal or suspension when such actions are taken to address safety concerns;
- Any other decision or information relevant to ensuring public safety.
As explained by the authority, its National Pharmacovigilance Center (NPC) is responsible to ensure the safety of marketed products through signal detection and initiation of necessary risk minimization measures. When making the relevant decisions, the NPC may rely on the respective regulatory decisions taken by other national authorities conducting similar functions.
In summary, the present DRAP guidance describes in detail the way the reliance approach should be applied with respect to clinical trial approval and pharmacovigilance. In particular, the document outlines the relevant provisions of the underlying regulations and provides additional clarifications regarding their application when making regulatory decisions on the products intended to be marketed and used in the country.
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