Regulatory authority (RA) plays a very significant role in Clinical research; they would be involved in all stages of the clinical development of a medicinal product. Regulatory authorities’ involvement in a Clinical Trial generally starts before conducting the clinical research, extends during the clinical research operations when RA plays the important role of interim monitoring of the trials and finally lasts till the end of the trial when they will be involved in providing a final approval of the marketing authorization of the particular product. Clinical Trials are generally conducted by different biopharmaceutical companies who have developed a new medicinal product/medical device, vaccines etc. and before application for the marketing authorization of their product/s they have to conduct clinical trials, to demonstrate the efficacy and safety of their product.
Application to the Regulatory Authorities for approval to start a clinical trial
Before conducting a Clinical Research, an application for the permission to start conducting a clinical Research must be sent to the corresponding Regulatory authorities by the sponsor.US-FDA (USA),DCGI (Drug Controller General of India) are the regulatory authorities in USA and India respectively. Applications for conducting clinical trials are generally submitted to the RA in the form of a Investigational New drug (IND) application. The IND application should include the pre-clinical study data, clinical trial data till date (if any), information about other properties of the Investigational product, a detailed study Protocol etc. Objectives of this application to the Regulatory authority (RA) is to ensure (i) Verification of patient safety and integrity,(ii) Verification of data, (iii) Adherence to laws and regulations, (iv) local and international level ethical guidelines compliance etc. Compliance with GCP standard provides public assurance that the rights, safety and the well-being of the trial subjects/participants are protected and that the clinical trial data are credible. The approval of the regulatory authority provides assurance that the proposal of the clinical trial is verified by a third neutral authority that is not related to the Sponsor Company or their business of drug development (which finally has goal of marketing the new drugs and generate revenues). They are neutral and regulatory authority of a particular region which would reassure the subject, subject’s family and public that participation in the clinical trial would be safe.
Clinical development monitoring through interim reports
After the receiving the approval from the corresponding RA, clinical trials could be started at different sites. Sponsor companies are liable to send to the regulatory authorities’ interim reports of the clinical trials which are known as DSUR (Development Safety Update Report). Also as part of post marketing surveillance (PMS), they have to send Periodic Safety Update Reports (PSURS) at regular intervals to the RA. The interim reporting review is also equally important to the reviews conducted before starting the Clinical trial. The interim reporting’ should help the RA to analyze the reports and safety concerns of an ongoing clinical trial or PMS before the completion of the respective studies. This analysis would prompt them to take the decision if the study could be given the permission to continue in future or they should be stopped before more people get affected from adverse events and toxic effects of the drug.
Application to Regulatory Authorities to obtain registration
After completion of a trial, a final clinical study report should be submitted to the regulatory authorities. This report must include the safety and efficacy related detailed information that has been collected during the clinical trial.
After completion of all the pre-marketing stages of development like phase I, phase II and phase III, all the preclinical study as well as all the clinical study data has to be compiled to form the New Drug Application (NDA) application. NDA application is submitted to the regulatory authorities to get marketing authorization of a particular medicinal product.
Thus regulatory authorities in different countries play a signification role in protection of the safety, well being and the rights of the human subjects who have participated in the Clinical Research.
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