Reporting to regulatory authority procedure.pptx

Regulatory reporting is a fundamental aspect of scientific research and is crucial for ensuring compliance with legal and ethical standards. It involves the systematic documentation and communication of research findings, methodologies, and compliance with safety protocols to regulatory authorities. These authorities, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, play a pivotal role in overseeing the safety, efficacy, and quality of medical products and research processes. Their mandate includes the protection of public health by ensuring that scientific studies, especially those involving human and animal subjects, adhere to stringent ethical and procedural guidelines.

In the context of preclinical and clinical research, regulatory reporting serves multiple purposes. It provides a transparent account of the research conducted, facilitating the review and approval process for new drugs, therapies, and medical devices. Reports submitted to regulatory bodies typically include detailed information on study design, methodologies employed, results obtained, and any adverse events observed. This comprehensive documentation helps regulators assess the potential risks and benefits associated with new interventions, thereby informing decision-making processes related to product approvals, market authorizations, and post-marketing surveillance.

Preclinical study reports are a critical component of regulatory submissions, particularly for studies involving organoids and spheroids. These advanced 3D cell culture models are increasingly used as alternatives to traditional animal testing, offering more accurate and ethical ways to study human biology and disease. Regulatory reports for such studies must include detailed descriptions of the organoid and spheroid models used, experimental protocols, data on viability and functionality, and any observed effects on cell behavior. The inclusion of such detailed information is essential for demonstrating the validity and reliability of the research findings to regulatory authorities.

In addition to preclinical reports, clinical trial reports are another vital element of regulatory reporting. These reports document the conduct and outcomes of clinical trials involving human participants. They must include comprehensive details on trial design, participant demographics, interventions administered, endpoints measured, and statistical analyses performed. Ethical considerations are paramount in clinical trial reporting, and researchers must ensure that their studies comply with the principles outlined in the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. This includes obtaining informed consent from participants, ensuring confidentiality, and promptly reporting any adverse events.
Post-marketing surveillance reports are crucial for ongoing monitoring of the safety and efficacy of approved products.

1. Reporting to Regulatory Authority By Vaishnavi Gohri Roll No: 4 F. Y. M. Pharm

2. ADR or adverse event reporting involves the triage, receipt, data entering, distribution, assessment, archiving and reporting of adverse event data and documentation Information collected during premarketing phase of drug development is incomplete with regard to possible ADR After drug approval in market over a wide range of population using medicines, evaluation of ADR is done know as Post marketing surveillance In order to maintain safe use of medicines & Public welfare Pharmacovigilance programme started in India Adverse Drug Event This are any adverse outcomes caused by medication used or by other factors An AE is a harmful and negative outcome that happens when a patient has been provided with medical care. This activity reviews the evaluation and management of an adverse event Highlights the role of interprofessional team members in collaborating to evaluate and manage the AE An adverse drug reaction is a harmful, unintended result caused by taking medication

3. CDSCO Working for Reporting ADR

4. Benefits It helps in evaluating the safety of drug therapies , especially of those drugs that are approved It offers updated drug safety information to health care professionals and other stakeholders It aids in evaluating the economic impact of ADR inhibition by reducing hospitalization, using optimal & economical drug, & by minimizing organizational liability It ensures patient’s safety by carrying out following regulatory action on the basis of ADR reports: Advancing Inserting package Marketing Authorization Recall (withdrawal) Recalling batch on the basis of ADR cluster Classification changes such as: a) From over the counter to prescription only medicines b) Special prescription c) Restricted prescription

5. Life-threatening events or deaths. Hospitalization of the patient. Congenital anomalies. Medically significant events (if considered serious by a physician). Lack of efficacy related to the use of a medical device or drug product. All suspected drug interactions. All known or unknown, serious, non-serious, frequent, or rare reactions by vaccine or drug What to Report?

6. Spontaneous cases should be reported within  10 days . Suspected ADRs should be reported as soon as possible B ecause overreporting is better than underreporting. Death events must be reported promptly, while other serious ADRs/events within  7 days . Non-serious cases should be reported within  30 days . When to Report?

7. Professionals working in healthcare teams are the preferred sources of information for pharmacovigilance (PV) Medical specialists Pharmacists Dentists Midwives P atients, patient relatives, witnesses, or any common person can report after medical confirmation Who Can Report?

8. Fill out the  ADR reporting form  and send it to the nearest Adverse Drug Reaction Monitoring Center (AMC) or directly to the National Coordination Centre (NCC) for Pharmacovigilance in India. Dial the toll-free helpline number  1800 180 3024  to report ADRs. Alternatively, email the filled ADR reporting form directly to  [email protected]  or  [email protected] . V isit the  Indian Pharmacopoeia Commission (IPC) website  or the  PvPI portal  for a list of authorized AMCs in India. How to Report?

9. Peripheral PV Center : Primary ADR information gathering centers, including small medical centers, private hospitals, dispensaries, nursing homes, and pharmacies. Regional PV Center : Secondary centers located in medical colleges with larger facilities, They are identified and coordinated by zonal centers There are five such regional centers in India. Zonal PV Center : Tertiary PV Centre generally located in metro city’s medical college having attachment of sufficient facility. It is identified by CDSCO and act as first ADR data collection center. Zonal center for North and East zone is AIIMS Where to Report?

10. List of Central Drug Standard Control Organization (CDSCO) Zonal and Sub-Zonal Offices Dr.  Rajeev Singh Raghuvanshi

11. Processing of ADR

12. The communication of drugs safety information among HCPs, patients, MAHs, and PV officials is essential for ADR Reporting. To ease this process, NCC- PvPI , IPC has developed several tools for ADR-reporting. For the convenience of Indian citizens, NCC- PvPI has launched ADR reporting forms Posted on the website of IPC (www.ipc.gov.in). The forms can be downloaded, filled, scanned, and sent to AMC or directly to NCC by post, mail, fax. If the forms are received directly at the NCC, they are first sent to the nearby AMC where the PV associate gets in touch with the person who has reported the AEs. The PV associate then takes sufficient information from the patient and then after filling the necessary information sends the report back to NCC as ICSRs.

13. Council for International Organizations of Medical Sciences (CIOMS) reporting form is the only internationally recognized format, which was designed in 1990 Providing ADR information on the new molecules which are under clinical trial by Marketing Authorization Holders (MAH) to regulatory body

14. Argentina Brazil Australia New Zealand United States Canada India Malaysia Singapore United Kingdom Sweden Kenya South ADRs forms of various countries (13 in the present case) were selected from six continents.

15. Considering the existing variability in ADR forms, the proposed generic ADR form is comprehensively designed to report information for correct causality as

16. THANKYOU..!!