DOI: http://dx.doi.org/10.18203/issn.2454-2156.IntJSciRep20175384

Overview of post marketing aggregate reports and global regulatory requirements

Paramaguru Rathinavelsamy

Abstract


Pharmacovigilance is the science that deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of pharmacovigilance has evolved over time. We now recognize the importance of a systematic approach for monitoring and improving the safe use of medicines. At the level of individual case safety reports, it is not possible for marketing authorization holders (MAH) to evaluate benefit/risk ratio profile and understand the detailed safety feature of a medicinal product. In addition to submission of individual case safety reports MAH also review periodically, cumulative safety information attained from various sources and submit the findings as aggregate reports to drug regulators. Aggregate reporting is a vital tool to study benefit/risk balance of a medicinal product throughout the product’s life cycle. The timelines, frequency and exact type of aggregate report required to be submitted for the approved product varies globally amongst various drug regulatory agencies. In this review the significance, background, objectives, scope, structural components, timelines for regulatory submissions of post marketing aggregate reports viz. PSUR, PBRER, and PADER have been discussed.

Keywords


Pharmacovigilance, Aggregate reporting, PSUR, PBRER, PADER, ADCO

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References


World Health Organization. Pharmacovigilance: Ensuring the Safe Use of Medicines - WHO Policy Perspectives on Medicines, 2004. Available at http://apps.who.int/medicinedocs/en/d/Js6164e/. Accessed on 17 November 2016.

World Health Organization. Safety of Medicines: A guide to detecting and reporting adverse drug reactions, 2002. Available at http://apps.who.int/ medicinedocs/es/d/Jh2992e/ Accessed on 17 November 2016.

Gagnon S, Gagnon S, Schueler P. Pharmacovigilance and Risk Management. In: Bairu M, Chin R, eds. Global Clinical Trials Playbook. 1st ed. United Kingdom, UK: Elsevier; 2012: 141-160.

The International Council for Harmonisation. Pharmacovigilance: ICH Topic E 2 C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, 1997. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002780.pdf. Accessed on 23 November 2016.

The International Council for Harmonisation. Pharmacovigilance: ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER), 2013. Available at: http://www.ich.org/products/ guidelines/efficacy/article/efficacy-guidelines.html. Accessed on 23 November 2016.

Committee for Human Medicinal Products (CHMP). Guideline on the processing of renewals in the centralized procedure, 2016. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/08/WC500211495. Accessed on 24 November 2016.

The Heads of Medicines Agencies (HMA). Human Medicines: CMDh best practice guide on the processing of renewals in the mutual recognition and decentralised procedures, 2015. Available at http://www.hma.eu/95.html. Accessed on 24 November 2016.

Food and Drug Administration (FDA). Post marketing reporting of adverse drug experiences, Code of Federal Regulations, 21CFR314.80, 2016. Available at https://www.gpo.gov/fdsys/granule/ CFR-2011-title21-vol5/CFR-2011-title21-vol5-sec314-80. Accessed on 06 December 2016.

Food and Drug Administration (FDA). Applications for FDA approval to market a new drug, Code of Federal Regulations, 21CFR314.80, 2016. Available at https://www.gpo.gov/fdsys/granule/CFR-2011-title21-vol5/CFR-2011-title21-vol5-sec314-80. Accessed on 06 December 2016.

Food and Drug Administration (FDA). Reporting of Adverse Experiences, Code of Federal Regulations, 21CFR314.80, 2016. Available at https://www.gpo. gov/fdsys/granule/CFR-2011-title21-vol5/CFR-2011-title21-vol5-sec314-80. Accessed on 06 December 2016.

Food and Drug Administration (FDA). Providing post marketing periodic safety reports in the ICH E2C(R2) format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry, 2016. Available at https://www.fda.gov/downloads/drugs/guidances/ucm346564. Accessed on 15 December 2016.

European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module VII - Periodic safety update report (Rev 1), 2013. Available at http://www.ema.europa.eu/ema/index .jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp. Accessed on 10 January 2017.

Health Canada. Drugs & Health Products: Guidance documents on Product Vigilance, 2013. Available on: http://www.hc-sc.gc.ca/dhpmps/prodpharma/ applic- demande/guide-ld/vigilance/index-eng.php; Accessed on 14 December 2016.

Therapeutic Goods Administration. Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines, 2014. Available on https://www.tga. gov.au/publication/australian-pharmacovigilance-requirements-and-recommendations-medicine-sponsors. Accessed on 18 January 2017.

Harvey B. Periodic Safety Update Reports - Some commonly asked questions, Association of Regulatory and Clinical Scientists (ARCS) Workshop, 2015. Available at: https://www.tga.gov. au/presentation-periodic-safety-update-reports-some-commonly-asked-questions. Accessed on 24 January 2017.

Health Sciences Authority, Singapore. Guidance for Industry – Post-marketing Vigilance Requirements for Medicinal Products, 2015. Available at: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Safety_Alerts_Product_Recalls_Enforcement/Guidance%20for%20Industry_Post-marketing%20Vigilance%20Req%20for%20Med%20Prod_June%202015. Accessed on 24 January 2017.

Central Drugs Standard Control Organization, India. Schedule “Y”, clause 4; Drug and Cosmetics Rules 1945, 2016. Available at: http://cdsco.nic.in/html/ D&C_Rules_Schedule_Y.pdf. Accessed on 12 December 2016.




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