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Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Page 75
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Page 76
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 77
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 78
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 79
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 80

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REFERENCES Acreditación, E. M. d. 2019. International agreements. Ahonkhai, V., S. F. Martins, A. Portet, M. Lumpkin, and D. Hartman. 2016. Speeding access to vaccines and medicines in low-and middle-income countries: A case for change and a framework for optimized product market authorization. PLOS One, -11(11):e0166515. Andrade, E.L., A. Bento, J. Cavalli, S.K. Oliveira, R.C. Schwanke, J.M. Siqueira, C.S. Freitas, R. Marcon, and J.B. Calixto. 2016. Non-clinical studies in the process of new drug development-part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Brazilian Journal of Medical and Biological Research, 49(12). APEC (Asia-Pacific Economic Cooperation). 2019. Life Sciences Innovation Forum. https://www.apec.org/Groups/Committee-on-Trade-and-Investment/Life-Sciences- Innovation-Forum (accessed September 20, 2019) Babigumira, J., A. Stergachis, T. Kanyok, L. Evans, M. Hajjou, P. Nkansah, V. Pribluda, L. Garrison, and J. Nwokike. 2018. A risk-based resource allocation framework for pharmaceutical quality assurance for medicines regulatory authorities in low- and middle- income countries. US Pharmacopeial Convention: Rockville, MD. Submitted to U.S. Agency for International Development. Board on Health Science Policy. 2018. Threats to pharmaceutical supply chains the public- private analytic exchange program research findings. In Medical Product Shortages during Disasters: Opportunities to Predict, Prevent, and Respond. Workshop conducted at the National Academy of Sciences Building, Washington, DC, September 5-6, 2018. Byrd, J. B., G. M. Chertow, and V. Bhalla. 2019. Hypertension hot potato — Anatomy of the angiotensin-receptor blocker recalls. New England Journal of Medicine, 380(17):1589– 591. Chace-Ortiz, M. 2017. The changing dynamics of global API manufacturing. Chemica Oggi/Chemistry Today, 35, pp. 40-42. Chauhan, G., V. Gupta. 2019. Developments and challenges: Adapting continuous manufacturing for pharmaceuticals. AAPS News Magazine. https://www.aapsnewsmagazine.org/articles/2019/apr19/cover-story-apr19 (accessed September 22, 2019) Correia de Brito, A., C. Kauffmann and J. Pelkmans. 2016. The contribution of mutual recognition to international regulatory co-operation. Organisation for Economic Co- operation and Development (OECD) Regulatory Policy Working Papers(No. 2). https://www.oecd.org/regreform/WP2_Contribution-of-mutual-recognition-to-IRC.pdf (accessed September 10, 2019) Dal Pan, G. J. 2014. Ongoing challenges in pharmacovigilance. Drug Safety, 37(1):1–8. EC (European Commission). 2017. Pharmaceutical committee 27 october 2017 79th meeting. EFPIA (European Federation of Pharmaceutical Industries and Associations). 2018. Annual regulatory gmp/gdp inspection survey 2017 data. EFTA (European Free Trade Association). 2019. Mutual recognition agreements. EMA (European Medicines Agency). 2009a. European medicines agency and u.S. Food and drug administration (fda) launch good clinical practice initiative. EMA. 2009b. Emea-fda gcp initiative PREPUBLICATION COPY: UNCORRECTED PROOFS 75

76 REGULATING MEDICINES IN A GLOBALIZED WORLD EMA. 2011. Final report on the international api inspection pilot programme. EMA. 2013. Mandate, objectives and rules of procedure: Good clinical practice inspectors working group (gcp iwg). EMA. 2015. Europe to boost international cooperation on generics. EMA. 2016. Connecting the dots: Towards global knowledge of the international medicine regulatory landscape: Mapping of international initiatives. EMA. 2018. Report on the international active pharmaceutical ingredient inspection programme 2011 – 2016. EMA. 2018b. Annual report of the good manufacturing and distribution practice inspectors working group 2017. EMA. 2019a. Bilateral interactions with non eu regulators - china EMA. 2019b. Angiotensin-ii-receptor antagonists (sartans) containing a tetrazole group. EMA. 2019c. Mutual recognition agreements (mra). EMA. 2019f. Cluster activities. EMA. 2019g. Working parties and other groups. EMA. 2019h. Access to documents. EMA. 2019i. 2018 annual report on eudravigilance for the european parliament, the council and the commission; reporting period: 1 january to 31 december 2018. EMA/906394/2019. FDA (Food and Drug Administration). 1988. Fda - netherlands, mou regarding good laboratory practice. FDA. 2015. Plan to increase access to results of fda-funded scientific research. FDA. 2016. Providing postmarketing periodic safety reports in the ich e2c(r2) format (periodic benefit-risk evaluation report): Guidance for industry. Drug Safety. FDA. 2017a. Emergency use authorization of medical products and related authorities: Guidance for industry and other stakeholders. FDA. 2017b. Securing the future for puerto rico: Restoring the island's robust medical product manufacturing sector. FDA. 2018. Foreign inspectional collaborations. FDA. 2018b. Foreign regulator information exchanges. FDA. 2018c. Fda announces voluntary recall of several medicines containing valsartan following detection of an impurity. FDA. 2018d. Statement by fda commissioner scott gottlieb, m.D., update on recovery efforts in puerto rico, and continued efforts to mitigate iv saline and amino acid drug shortages. FDA. 2018e. Questions and answers on fda's adverse event reporting system (faers). FDA. 2019a. Mutual recognition agreement (mra). FDA. 2019b. Questions and answers on current good manufacturing practices—production and process controls. FDA. 2019c. Report on drug shortages for calendar year 2018. GAO (Government Accountability Office). 2008. Better data management and more inspections are needed to strengthen fda’s foreign drug inspection program. Report to Congressional Requesters. GAO. 2016. Fda has improved its foreign drug inspection program, but needs to assess the effectiveness and staffing of its foreign offices. Report to the Committee on Energy and Commerce. GAO. 2019. Substantial efforts needed to achieve greater progress on high-risk areas. Report to Congressional Committees. PREPUBLICATION COPY: UNCORRECTED PROOFS

REFERENCES 77 Hans, M., and S.K. Gupta. 2018. Comparative evaluation of pharmacovigilance regulation of the united states, united kingdom, canada, india and the need for global harmonized practices. Perspectives in Clinical Research, 9(4):170. Harston, A. 2019. How the u.S. Compares to europe on biosimilar approvals and products in the pipeline. Rothwell Figg Blog. HAS (Health Sciences Authority). Update on asean mra on gmp conformity assessment for medicinal product registration in singapore. Hunter, P. 2017. Advanced therapies push regulatory boundaries: Novel therapeutic approaches require more regulatory flexibility and transparency. EMBO Reports 18(12). IBEF (India Brand Equity Foundation). 2019. Indian pharmaceuticals industry analysis. ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). 2016a. Ich e6 good clinical practice (gcp) guideline. ICH. 2016b. Integrated addendum to ich e6(r1): Guideline for good clinical practice e6(r2). ICH. 2019. Welcome to the ich official website. ICMRA (International Coalition of Medicines Regulatory Authorities). 2017. Capacity building working group final report. ILAC (International Laboratory Accreditation Cooperation). 2019. Ilac’s role. IPRP (International Pharmaceutical Regulators Programme). 2019. International pharmaceutical regulators programme. ISO (International Organization for Standardization). 2012. Iso/iec 17020:2012 [-,iec] conformity assessment — requirements for the operation of various types of bodies performing inspection. Iyengar, S., L. Hedman, G. Forte, and S. Hill. 2016. Medicine shortages: A commentary on causes and mitigation strategies. J BMC medicine 14(1):124. Kashoki, M., Z. Hanaizi, S. Yordanova, R. Veselý, C. Bouygues, J. Llinares, S.L. Kweder. 2019. A comparison of ema and fda decisions for new drug marketing applications 2014–2016: Concordance, discordance, and why. Clinical Pharmacology and Therapeutics Kulkarni, T. N., and N. G. Kulkarni. 2019. Authoring a periodic adverse drug experience report… here's what you need to know! J Perspectives in clinical research 10(2):95. Luigetti, R., Bachmann, P., Cooke, E., Salmonson, T. 2016. Collaboration, not competition: Developing new reliance models. WHO Drug Information 30(4):558-566. Myles, P. S., E. Williamson, J. Oakley, and A. J. T. Forbes. 2014. Ethical and scientific considerations for patient enrollment into concurrent clinical trials. 15(1):470. Ni, J., J. Zhao, C. O. L. Ung, Y. Hu, H. Hu, Y. J. G. Wang, and health. 2017. Obstacles and opportunities in chinese pharmaceutical innovation. 13(1):21. OECD. 2013a. Oecd recommendation on the governance of clinical trials. OECD. 2013b. International regulatory co-operation: Addressing global challenges: OECD Publishing. OECD. 2014. Regulatory enforcement and inspections. OECD. 2019. Good laboratory practice (glp). PAHO (Pan American Health Organization). 2019a. Regulatory reliance principles: Concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, 24 to 26 October, 2018). PAHO. 2019b. Pandrh members. Paquette, M., J. Kelecevic, L. Schwartz, and R. J. C. c. t. c. Nieuwlaat. 2019. Ethical issues in competing clinical trials. 14:100352. PREPUBLICATION COPY: UNCORRECTED PROOFS

78 REGULATING MEDICINES IN A GLOBALIZED WORLD Patel, K., and N. Chotai. 2011. Documentation and records: Harmonized gmp requirements. Journal of young pharmacists 3(2):138-150. Patel, P., N. McAuslane, and L. Liberti. 2019. R&d briefing 71: Trends in the regulatory landscape for the approval of new medicines in latin america. Centre for Innovation in Regulatory Science. London, UK. Pharmaceuticals, I. D. o. 2018. Annual report 2017-2018. PICS (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme). 2017. Standard operating procedure: Procedure for handling rapid alerts and recalls arising from quality defects. PICS. 2019a. Press release: Pic/s meetings in geneva (switzerland). PICS. 2019b. Focused stakeholders consultation on revised draft pic/s gmp guide annex 2a (manufacture of advanced therapy medicinal products for human use) and annex 2b (manufacture of biological medicinal substances and products for human use) Ratanawijitrasin, S., E. Wondemagegnehu, and E. Wondemagegnebu. 2002. Effective drug regulation: A multicountry study: World Health Organization. Ravinetto, R., H. Tinto, E. Diro, J. Okebe, Y. Mahendradhata, S. Rijal, E. Gotuzzo, P. Lutumba, A. Nahum, and K. J. B. g. h. De Nys. 2016. It is time to revise the international good clinical practices guidelines: Recommendations from non-commercial north–south collaborative trials. 1(3):e000122. Rees, V. 2019a. The impact of counterfeit drugs in south and south-east asia. European Pharmaceutical Review. Rees, V. 2019b. Us and india receive most warning letters from fda. European Pharmaceutical Review. Rönninger, S., S. Schmitt, V. Rangavajhula, E. Hough, and J. Lyda. 2012. Considerations on auditing and gxp requirements along the product lifecycle. J PDA journal of pharmaceutical science technology 66(5):396-402. Roth, L., D. Bempong, J. B. Babigumira, S. Banoo, E. Cooke, D. Jeffreys, L. Kasonde, H. G. Leufkens, J. C. Lim, M. J. G. Lumpkin, and health. 2018. Expanding global access to essential medicines: Investment priorities for sustainably strengthening medical product regulatory systems. 14(1):102. Saint Raymond, A. 2019. Mutual recognition agreements and reliance in the regulation of medicines Schwartz, M. 2017. Another brick in the wall: A new commitment implementing the mutual recognition of inspections. FDA Law Blog. Sravani, M., M. S. Kusuma, A. Prabhahar, and R. Nadendla. 2017. Registration of generic drugs in central america and mexico. International Journal of Pharma And Chemical Research 3(3). TGA (Therapeutic Goods Administration). 2018. Comparable overseas regulators (cors) for prescription medicines: Criteria, cor report-based process and worksharing. TGA. 2019b. Australia-canada-singapore-switzerland (acss) consortium. Tsang, L., Kracov, D. 2017. Impact of the eu-us mutual recognition agreement on pharmaceutical product inspections. Arnold & porter. UNODC (United Nations Office on Drugs and Crime). 2019. Transnational organized crime in southeast asia: Evolution, growth and impact. Vinther, A. 2016. Drug shortage is a "wicked problem". PDA Letter. PREPUBLICATION COPY: UNCORRECTED PROOFS

REFERENCES 79 WHO (World Health Organization). 2009. Handbook: Good laboratory practice (glp): Quality practices for regulated non-clinical research and development - 2nd ed. WHO. 2016a. Good regulatory practices: 5 guidelines for national regulatory authorities for medical 6 products. WHO. 2016b. Zika virus and complications: 2016 public health emergency of international concern. WHO. 2016c. Who zika virus research agenda. WHO. 2016d. Collaboration, not competition: Developing new reliance models. WHO Drug Information 30(4). WHO. 2017a. China policies to promote local production of pharmaceutical products and protect public health. WHO. 2017b. Prequalification process quality improvement initiatives: 2010–2016. WHO Drug Information 31(3). WHO. 2018. Addressing the global shortage of, and access to, medicines and vaccines. EB142/13. WHO. 2019. Guidelines on the implementation of the who certification scheme on the quality of pharmaceutical products moving in international commerce. WHO. 2019c. Immunization standards: National regulatory authorities. WHO. 2019d. Essential medicines and health products: Why we need strong regulatory systems to reach universal health coverage. WHO. 2019e. Essential medicines and health products: Prequalification of medicines - capacity building. WHO. 2019f. Essential medicines and health products: Prequalification of medicines - who public inspection reports (whopirs). WHO. 2019g. Essential medicines and health products: Pharmacovigilance. WHO. 2019h. Essential medicines and health products: Post market surveillance. WHO. 2019i. Who’s approach to promoting reliance. Presentation at the 8th Asia Partnership Conference of Pharmaceutical Associations (APAC), 09 April 2019, Tokyo, Japan. Wilkinson, E. 2019. India and china spark concerns for uk drug supplies. The Pharmaceutical Journal 303(7928). Wilson, B. J., and S. G. Nicholls. 2015. The human genome project, and recent advances in personalized genomics. J Risk management healthcare policy 8:9. Zall Kusek, J., and R. Rist. 2004. Ten steps to a results-based monitoring and evaluation system: A handbook for development practitioners: The World Bank. Zhai, M. Z., A. Sarpatwari, and A. S. Kesselheim. 2019. Why are biosimilars not living up to their promise in the us? AMA Journal of Ethics 21(8):E668–678. PREPUBLICATION COPY: UNCORRECTED PROOFS

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Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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