Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance

1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use , https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf (accessed 5 March 2021).
Google Scholar2. European Medicines Agency . Guideline on good pharmacovigilance practices (GVP) Module V –Risk Management System (Rev 2), https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-goodpharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf (accessed 5 March 2021).
Google Scholar3. Tawde, SA. Generic Pharmaceuticals: is pharmacovigilance required? J Pharmacovigil 2014; 2: 6.
Google Scholar | Crossref4. Pedersen, SA, Gaist, D, Schmidt, SAJ, et al. Hydrochlorothiazide use and risk of nonmelanoma skin cancer: A nationwide case-control study from Denmark. J Am Acad Dermatol 2018; 78: 673.e9–681.e9.
Google Scholar | Crossref | Medline5. European Medicines Agency . Guideline on Good Pharmacovigilance Practices (GVP) Product- or Population-Specific Considerations II: biological medicinal products, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-product-population-specific-considerations-ii_en-0.pdf (accessed 27 April 2021).
Google Scholar6. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines , https://ec.europa.eu/health/documents/eudralex/vol-4_en (accessed 5 March 2021).
Google Scholar7. Guidelines of 5 November 2013 on good distribution practice of medicinal products for human use , https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:0014:EN:PDF (accessed 5 March 2021).
Google Scholar8. European Medicines Agency . Guideline on good pharmacovigilance practices (GVP), https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices (accessed 5 March 2021).
Google Scholar9. European Medicines Agency . ICH guideline Q9 on quality risk management, https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf (accessed 8 May 2021).
Google Scholar10. European Medicines Agency . ICH guideline Q10 on pharmaceutical quality system, https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human_en.pdf (accessed 8 May 2021).
Google Scholar11. European Medicines Agency . Comparability of biotechnology–derived medicinal products after a change in the manufacturing process – non-clinical and clinical issues, https://www.ema.europa.eu/en/comparability-biotechnology-derived-medicinal-products-after-change-manufacturing-process-non (accessed 7 May 2021).
Google Scholar12. Beninger, P. Commentary opportunities for collaboration at the interface of pharmacovigilance and manufacturing. Clin Therap 2017; 39: 4.
Google Scholar | Crossref13. List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness . Federal Register – The Daily Journal of the United States Government, https://www.federalregister.gov/documents/2018/12/11/2018-26712/list-of-drug-products-that-have-been-withdrawn-or-removed-from-the-market-for-reasons-of-safety-or#p-14 (accessed 18 January 2021).
Google Scholar14. European Medicine Agency . List of withdrawn medicinal products, https://www.ema.europa.eu/documents/other/list-withdrawn-medicinal-products-accordance-art-1234-directive_en-2.xls (28 February 2019, accessed 18 January 2021).
Google Scholar15. Department of Health UK . Drug alerts2020, https://www.gov.uk/drug-device-alerts (accessed 7 May 2021).
Google Scholar16. European Medicines Agency . Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities, https://www.ema.europa.eu/en/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-sartan-medicines-companies-review_en.pdf (accessed 15 February 2021).
Google Scholar17. European Medicines Agency . Referral: angiotensin II receptor antagonists–sartans–article 31 – Annex I – Scientific Conclusions – CHMP Opinion, https://www.ema.europa.eu/en/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_en.pdf (accessed 13 February 2021).
Google Scholar18. European Medicines Agency . Lessons learnt from presence of N-nitrosamine impurities in Sartan medicines. https://www.ema.europa.eu/en/documents/report/lessons-learnt-presence-n-nitrosamine-impurities-sartan-medicines_en.pdf (accessed 13 January 2021).
Google Scholar19. European Medicines Agency . Assessment report. Nitrosamines EMEA-H-A5(3)-1490, https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-assessment-report_en.pdf (accessed 5 March 2021).
Google Scholar20. European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines , https://www.ema.europa.eu/en/documents/referral/european-medicines-regulatory-network-approach-implementation-chmp-opinion-pursuant-article-53/2004-nitrosamine-impurities-human-medicines_en.pdf (accessed 25 March 2021).
Google Scholar21. Chazin, HD, Peters, JR, Catterson, DM, et al. The author(s) pharmacovigilance and risk management strategies 2017: overview of the generic drug program and surveillance. Ther Innov Regul Sci 2019; 53: 249–253.
Google Scholar | SAGE Journals | ISI22. Medicines and Healthcare products Regulatory Agency . Report on the suspension of the Teva marketing authorisation for levothyroxine 100 microgram tablets, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/425413/Suspension_of_the_Teva_marketing_authorisation_for_Levothyroxine_100_microgram_tablets.pdf (accessed 13 January 2021).
Google Scholar23. European Medicines Agency. Assessment report . Procedure no: EMEA/H/A-5(3)/1468. INN/active substance: gentamicin (solution for infusion/solution for injection) EMA/805330/2018, https://www.ema.europa.eu/en/documents/referral/assessment-report-article-53-procedure-gentamicin_en.pdf (accessed 2 May 2021).
Google Scholar24. Kishimoto, TK, Viswanathan, K, Ganguly, T, et al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med 2008; 358: 2457–2467.
Google Scholar | Crossref | Medline | ISI25. Chess, EK, Bairstow, S, Donovan, S, et al. Case study: contamination of heparin with oversulfated chondroitin sulfate. Handb Exp Pharmacol 2012; 207: 99–125.
Google Scholar | Crossref26. Food and Drug Administration . Response to heparin contamination helped protect public health; controls that were needed for working with external entities were recently added, https://www.gao.gov/assets/320/311879.pdf (accessed 18 January 2021).
Google Scholar27. Boven, K, Stryker, S, Knight, J, et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 2005; 67: 2346–2353.
Google Scholar | Crossref | Medline | ISI28. Macdougall, IC, Casadevall, N, Locatelli, F, et al. Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS). Nephrol Dial Transplant 2015; 30: 451–460.
Google Scholar | Crossref | Medline29. O’Callaghan, J, Griffin, BT, Morris, JM, et al. Knowledge of adverse drug reaction reporting and the pharmacovigilance of biological medicines: a survey of healthcare professionals in Ireland. Biodrugs 2018; 32: 267–280.
Google Scholar | Crossref | Medline30. Klein, K, Scholl, JH, Vermeer, NS, et al. Traceability of biologics in The Netherlands: an analysis of information-recording systems in clinical practice and spontaneous ADR reports. Drug Saf 2016; 39: 185–192.
Google Scholar | Crossref | Medline31. European Medicine Agency . Advanced therapy medicinal products: overview, https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview (accessed 5 March 2021).
Google Scholar32. European Medicine Agency. Committee for Medicinal Products for Human Use (CHMP) . Guideline on safety and efficacy follow-up – risk management of advanced therapy medicinal products. Doc. Ref. EMEA/149995/2008, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-safety-efficacy-follow-risk-management-advanced-therapy-medicinal-products_en.pdf (accessed 24 February 2021).
Google Scholar33. European Medicine Agency . Committee for Medicinal Products for Human Use (CHMP). Guideline on safety and efficacy follow-up – risk management of advanced therapy medicinal products. Doc. EMEA/149995/2008 rev.1, https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-efficacy-follow-risk-management-advanced-therapy-medicinal-products-revision_en.pdf (accessed 24 February 2021).
Google Scholar34. Heyward, J, Olson, L, Sharfstein, JM, et al. Evaluation of the extended-release/long-acting opioid prescribing risk evaluation and mitigation strategy program by the US food and drug administration: a review. JAMA Intern Med 2020; 180: 301–309.
Google Scholar | Crossref | Medline35. Schering Resumes Sales in Brazil . https://apnews.com/article/c2c72d500df51a8dc54d5e843f6bad37 (accessed 27 February 2021).
Google Scholar36. European Medicines Agency . Guideline on good pharmacovigilance practices (GVP) Module VI – Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2), https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf (accessed 5 March 2021).
Google Scholar37. World Health Organization . Substandard and falsified medical products, https://www.who.int/en/news-room/fact-sheets/detail/substandard-and-falsified-medical-products (31 January 2018, accessed 13 February 2021).
Google Scholar38. World Health Organization . Medical product alert N°2/2021. Falsified COVID-19 Vaccine BNT162b2 identified in the WHO region of the Americas, https://www.who.int/news/item/26-03-2021-medical-product-alert-n-2-2021-falsified-covid-19-vaccine-bnt162b2 (26 March 2021, accessed 29 March 2021).
Google Scholar39. World Health Organization . Medical product alert N°7/2020. Falsified HARVONI (Ledipasvir/sofosbuvir) identified in the WHO regions of the Americas and Europe, https://www.who.int/news/item/08-12-2020-medical-product-alert-n-7-2020 (8 December 2020, accessed 13 February 2021).
Google Scholar40. World Health Organization . Medical product alert N°5/2020. Falsified and contaminated Defibrotide identified in WHO regions of Western Pacific, Europe and Eastern Mediterranean, https://www.who.int/news/item/07-05-2020-medical-product-alert-n-5-2020#:~:text=On%2013%20March%202020%2C%20the,1%20below%20for%20full%20details) (1 July 2020, accessed 13 February 2021).
Google Scholar41. World Health Organization . Medical product alert N°4/2020. Falsified chloroquine products circulating in the WHO region of Africa, https://www.who.int/news/item/09-04-2020-medical-product-alert-n4-2020#:~:text=UPDATE%20(of%209%20June%202020,are%20included%20in%20this%20update (9 June 2020, accessed 13 February 2021).
Google Scholar42. World Health Organization . Medical product alert N°3/2020. Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19, https://www.who.int/news/item/31-03-2020-medical-product-alert-n-3-2020 (31 March 2020, accessed 13 February 2021).
Google Scholar43. World Health Organization . Medical product alert N°11/2019. Falsified Amoxicillin + Clavulanic Acid products circulating in Haiti, https://www.who.int/medicines/publications/drugalerts/drug_alert-11-2019/en/ (accessed 13 February 2021).
Google Scholar44. World Health Organization . Medical product alert N°8/2019. Falsified rabies vaccines and anti-rabies serum circulating in the Philippines, https://www.who.int/medicines/publications/drugalerts/drug_alert-8-2019/en/ (accessed 13 February 2021).
Google Scholar45. World Health Organization . Medical product alert N°7/2019. Falsified meglumine antimoniate ampoules in Iran and Pakistan, https://www.who.int/medicines/publications/drugalerts/drug_alert-7-2019/en/ (accessed 13 February 2021).
Google Scholar46. World Health Organization . Medical product alert N°6/2019. Falsified hydrochlorothiazide (containing glibenclamide) in Cameroon, https://www.who.int/news/item/17-04-2019-medical-product-alert-n-6-2019-(english-version)
Google Scholar47. World Health Organization . Substandard and falsified medical products – overview, https://www.who.int/health-topics/substandard-and-falsified-medical-products#tab=tab_1 (accessed 13 February 2021); https://www.who.int/medicines/publications/drugalerts/drug_alert-6-2019/en/ (accessed 13 February 2021).
Google Scholar48. Juhlin, K, Karimi, G, Andér, M, et al. Using VigiBase to identify substandard medicines: detection capacity and key prerequisites. Drug Saf 2015; 38: 373–382.
Google Scholar | Crossref | Medline49. Pinheiro, LC, Candore, G, Zaccaria, C, et al. An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance. Pharmacoepidemiol Drug Saf 2018; 27: 38–45.
Google Scholar | Crossref | Medline

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