References
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). doi: 10.1590/1414-431X20165646.
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).
Aronov, I. Z., A. M. Rybakova, V. Y. Salamatov, A. V. Tangaeva, and N. M. Galkina. 2019. Application of Chow test to estimate the effect of mutual recognition agreements. International Journal of Mathematical, Engineering and Management Sciences 4(3):591–600.
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. Rockville, MD: US Pharmacopeial Convention.
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):1589–1591.
Chace-Ortiz, M. 2017. The changing dynamics of global API manufacturing. Chemica Oggi—Chemistry Today 35:40–42.
Cooke, E. 2019. WHO’s Approaches to Promoting Reliance. PowerPoint presention at the July 10–11, 2019, meeting of the Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines, London, UK.
Correia de Brito, A., C. Kauffmann, and J. Pelkmans. 2016. The contribution of mutual recognition to international regulatory co-operation. OECD Regulatory Policy Working Paper No. 2. https://www.oecd.org/regreform/WP2_Contribution-of-mutual-recognitionto-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. Summary Record. https://ec.europa.eu/health/sites/health/files/files/committee/pharm742_summary_record_final.pdf (accessed September 19, 2019).
EFPIA (European Federation of Pharmaceutical Industries and Associations). 2018. Annual regulatory GMP/GDP inspection survey 2017 data. https://www.efpia.eu/media/361849/_efpia-2017-reg-inspection-survey_public-summary.pdf (accessed September 18, 2019).
EMA (European Medicines Agency). 2009a. EMEA-FDA GCP initiative. General-EMEA/INS/GCP/541006/2008. https://www.ema.europa.eu/en/documents/other/european-medicinesagency-food-drug-administration-good-clinical-practice-initiative_en.pdf (accessed September 22, 2019).
EMA. 2009b. European Medicines Agency and U.S. Food and Drug Administration (FDA) launch good clinical practice initiative. Press Release. London, UK: EMA. https://www.ema.europa.eu/en/news/european-medicines-agency-us-food-drug-administration-fda-launch-good-clinical-practice-initiative (accessed September 18, 2019).
EMA. 2011. Final report on the International API Inspection Pilot Programme. https://www.ema.europa.eu/en/documents/report/final-report-international-active-pharmaceuticalingredient-inspection-pilot-programme_en.pdf (accessed September 27, 2019).
EMA. 2013. Mandate, objectives and rules of procedure: Good Clinical Practice Inspectors Working Group (GCP IWG). https://www.ema.europa.eu/en/documents/other/mandateobjectives-rules-procedure-gcp-inspectors-working-group-gcp-iwg_en.pdf (accessed September 19, 2019).
EMA. 2015. Europe to boost international cooperation on generics. News Release. https://www.ema.europa.eu/en/news/europe-boost-international-cooperation-generics (accessed September 23, 2019).
EMA. 2016. Connecting the dots: Towards global knowledge of the international medicine regulatory landscape: Mapping of international initiatives. https://www.ema.europa.eu/en/documents/leaflet/connecting-dots-towards-global-knowledge-international-medicineregulatory-landscape-mapping_en.pdf (accessed September 12, 2019).
EMA. 2018a. Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2017. https://www.ema.europa.eu/en/documents/report/annual-reportgood-manufacturing-distribution-practice-inspectors-working-group-2017_en.pdf (accessed September 18, 2019).
EMA. 2018b. Report on the international active pharmaceutical ingredient inspection programme 2011–2016. https://www.ema.europa.eu/en/documents/report/report-international-activepharmaceutical-ingredient-api-inspection-programme-2011-2016_en.pdf (accessed September 20, 2019).
EMA. 2019a. 2018 Annual report on EudraVigilance for the European Parliament, the Council and the Commission. Reporting period: 1 January to 31 December 2018. https://www.ema.europa.eu/en/documents/report/2018-annual-report-eudravigilance-europeanparliament-council-commission-reporting-period-1-january_en.pdf (accessed September 20, 2019).
EMA. 2019b. Access to documents. https://www.ema.europa.eu/en/about-us/how-we-work/access-documents (accessed September 28, 2019).
EMA. 2019c. Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group. https://www.ema.europa.eu/en/medicines/human/referrals/angiotensin-ii-receptor-antagonists-sartans-containing-tetrazole-group (accessed September 16, 2019).
EMA. 2019d. Bilateral interactions with non-EU regulators—China. https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/china (accessed September 26, 2019).
EMA. 2019e. Cluster activities. https://www.ema.europa.eu/en/partners-networks/internationalactivities/cluster-activities (accessed September 29, 2019).
EMA. 2019f. Mutual recognition agreements (MRA). https://www.ema.europa.eu/en/humanregulatory/research-development/compliance/good-manufacturing-practice/mutualrecognition-agreements-mra (accessed September 2, 2019).
EMA. 2019g. Working parties and other groups. https://www.ema.europa.eu/en/committes/working-parties-other-groups (accessed September 4, 2019).
FDA (U.S. Food and Drug Administration). 1988. FDA–Netherlands, MOU regarding good laboratory practice. https://www.fda.gov/international-programs/cooperativearrangements/fda-netherlands-mou-regarding-good-laboratory-practice (accessed September 16, 2019).
FDA. 2015a. Manual of compliance policy guides. https://www.fda.gov/inspections-complianceenforcement-and-criminal-investigations/compliance-manuals/manual-compliance-policyguides (accessed September 29, 2019).
FDA. 2015b. Plan to increase access to results of FDA-funded scientific research. https://www.fda.gov/media/90883/download (accessed September 10, 2019).
FDA. 2016. Providing postmarketing periodic safety reports in the ICH E2C(R2) format (periodic benefit-risk evaluation report): Guidance for industry. https://www.fda.gov/media/85520/download (accessed September 16, 2019).
FDA. 2017a. Emergency use authorization of medical products and related authorities: Guidance for industry and other stakeholders. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-andrelated-authorities (accessed September 15, 2019).
FDA. 2017b. Securing the future for Puerto Rico: Restoring the island’s robust medical product manufacturing sector. https://www.fda.gov/media/108975/download (accessed September 23, 2019).
FDA. 2018a. FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. Press Release. https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containingvalsartan-following-detection-impurity (accessed September 30, 2019).
FDA. 2018b. Foreign regulator information exchanges. https://www.fda.gov/vaccines-bloodbiologics/international-activities/foreign-regulator-information-exchanges (accessed September 3, 2019).
FDA. 2018c. Questions and answers on FDA’s adverse event reporting system (FAERS). https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers (accessed September 30, 2019).
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. Press Release. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-update-recovery-efforts-puerto-rico-andcontinued (accessed September 30, 2019).
FDA. 2019a. E19 New drug regulatory program modernization: Improving approval package E documentation and communication. Federal Register 84(124):30733–30736.
FDA. 2019b. Mutual recognition agreement (MRA). https://www.fda.gov/internationalprograms/international-arrangements/mutual-recognition-agreement-mra (accessed August 18, 2019).
FDA. 2019c. Report on drug shortages for calendar year 2018. https://www.fda.gov/media/130561/download (accessed September 15, 2019).
GAO (U.S. Government Accountability Office). 2008. Better data management and more inspections are needed to strengthen FDA’s foreign drug inspection program. News Release. https://www.gao.gov/new.items/d08970.pdf (accessed September 9, 2019).
GAO. 2016. FDA has improved its foreign drug inspection program, but needs to assess the effectiveness and staffing of its foreign offices. GAO Highlights. https://www.gao.gov/assets/690/681689.pdf (accessed September 9, 2019).
GAO. 2019. Substantial efforts needed to achieve greater progress on high-risk areas. https://www.gao.gov/assets/700/697245.pdf (accessed September 9, 2019).
Garbe, J. H. O., K. Ennis, G. M. Furer, M. G. Jacobs, and S. Rönninger. 2015. Import testing of pharmaceutical products has limited safety benefits and can add risk to patients. Pharmaceutical Technology 2015 Supplement(3):s18–s26.
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):170–174.
Harston, A. 2019. How the U.S. compares to Europe on biosimilar approvals and products in the pipeline. Rothwell Figg, October 29. https://www.biosimilarsip.com/2019/05/07/how-the-u-s-compares-to-europe-on-biosimilar-approvals-and-products-in-the-pipeline-4 (accessed September 13, 2019).
HC (Health Canada). 2018. Australia Canada Singapore Switzerland (ACSS) Consortium–Erleada approval. July 13. https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/improving-review-drugs-devices/notice-erleada.html (accessed September 24, 2019).
HSA (Health Sciences Authority). n.d. Update on ASEAN MRA on GMP conformity assessment for medicinal product registration in Singapore. https://www.hsa.gov.sg/content/dam/HSA/HPRG/Western_Medicine/Overview_Framework_Policies/Guidelines_on_Drug_Registration/Industry%20Updates/Update%20on%20ASEAN%20MRA%20GMP.pdf (accessed September 15, 2019).
Hunter, P. 2017. Advanced therapies push regulatory boundaries: Novel therapeutic approaches require more regulatory flexibility and transparency. EMBO Reports 18(12):2101–2104.
Hussaarts, L., S. Mühlebach, V. P. Shah, S. McNeil, G. Borchard, B. Flühmann, V. Weinstein, S. Neervannan, E. Griffiths, and W. Jiang. 2017. Equivalence of complex drug products: Advances in and challenges for current regulatory frameworks. Annals of the New York Academy of Sciences 1407(1):39–49.
IBEF (India Brand Equity Foundation). 2019. Indian pharmaceuticals industry analysis. https://www.ibef.org/industry/indian-pharmaceuticals-industry-analysis-presentation (accessed November 1, 2019).
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). 2016. Integrated addendum to ICH E6(R1): Guideline for good clinical practice E6(R2). https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf (accessed September 17, 2019).
ICH. 2019. Welcome to the ICH official website. https://www.ich.org/home.html (accessed September 26, 2019).
ICMRA (International Coalition of Medicines Regulatory Authorities). 2017. Capacity Building Working Group final report. http://www.icmra.info/drupal/strategicinitiatives/capacitybuilding (accessed September 5, 2019).
ICMRA. 2019. International Coalition of Medicines Regulatory Authorities. http://www.icmra.info/drupal (accessed September 30, 2019).
ILAC (International Laboratory Accreditation Cooperation). 2019. ILAC’s role. https://ilac.org/about-ilac/role (accessed September 10, 2019).
Indian Department of Pharmaceuticals. 2018. Annual report 2017–2018. https://pharmaceuticals.gov.in/sites/default/files/Annual%20Report%202017-18.pdf (accessed September 15, 2019).
IPRP (International Pharmaceutical Regulators Programme). 2019. International Pharmaceutical Regulators Programme. http://www.iprp.global/home (accessed September 28, 2019).
ISO (International Organization for Standardization). 2012. ISO/IEC 17020:2012 conformity assessment—requirements for the operation of various types of bodies performing inspection. https://www.iso.org/standard/52994.html (acccessed September 20, 2019).
Iyengar, S., L. Hedman, G. Forte, and S. Hill. 2016. Medicine shortages: A commentary on causes and mitigation strategies. BMC Medicine 14(1):124.
Kashoki, M., Z. Hanaizi, S. Yordanova, R. Veselý, C. Bouygues, J. Llinares, and S. L. Kweder. 2020. A comparison of EMA and FDA decisions for new drug marketing applications 2014–2016: Concordance, discordance, and why. Clinical Pharmacology and Therapeutics 107(1):195–202. doi: 10.1002/cpt.1565.
Khadem, A. 2019. WHO Regulatory Systems Strengthening Programme: WHO role in building effective and efficient regulatory systems for health products. World Health Organization. https://www.who.int/medicines/technical_briefing/tbs/TBS2019_WHO_RSS_Capacity_Building_GBT.pdf (accessed September 30, 2019).
Kulkarni, T. N., and N. G. Kulkarni. 2019. Authoring a periodic adverse drug experience report… here’s what you need to know! Perspectives in Clinical Research 10(2):95–91.
La Entidad Mexicana de la Acreditación. 2019. International agreements. https://www.ema.org.mx/portal_v3/index.php/international-agreeementsi (accessed October 2, 2019).
Lesko, L. J., and J. Woodcock. 2004. Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective. Nature Reviews Drug Discovery 3:763–769.
Luigetti, R., P. Bachmann, E. Cooke, and T. Salmonson. 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. Trials 15(1):470.
Ni, J., J. Zhao, C. O. L. Ung, Y. Hu, H. Hu, and Y. J. G. Wang. 2017. Obstacles and opportunities in Chinese pharmaceutical innovation. Globalization and Health 13(Art. 21). doi: 10.1186/s12992-017-0244-6.
OECD (Organisation for Economic Co-operation and Development). 2013a. International regulatory co-operation: Addressing global challenges. Paris, France: OECD Publishing. doi: 10.1787/9789264200463-en.
OECD. 2013b. OECD recommendation on the governance of clinical trials. http://www.oecd.org/sti/inno/oecd-recommendation-governance-of-clinical-trials.pdf (accessed September 30, 2019).
OECD. 2014. Regulatory enforcement and inspections. https://www.oecd-ilibrary.org/content/publication/9789264208117-en (accessed September 27, 2019).
OECD. 2019. Good laboratory practice (GLP). https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm (accessed September 27, 2019).
Office of the Director of National Intelligence. 2018. Threats to pharmaceutical supply chains the public-private analytic exchange program research findings. https://www.dni.gov/files/PE/Documents/2018_AEP-Pharmaceutical.pdf (accessed September 23, 2019).
PAHO (Pan American Health Organization). 2019a. PANDRH’s members. https://www.paho.org/hq/index.php?option=com_content&view=article&id=11825:rede-parfmiembros&Itemid=41777&lang=en (accessed September 30, 2019).
PAHO. 2019b. Regulatory reliance principles: Concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, October 24–26, 2018). http://iris.paho.org/xmlui/bitstream/handle/123456789/51549/PAHOHSS19003_eng.pdf (accessed September 16, 2019).
Paquette, M., J. Kelecevic, L. Schwartz, and R. Nieuwlaat. 2019. Ethical issues in competing clinical trials. Contemporary Clinical Trials Communiations 14:100352.
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. London, UK: Centre for Innovation in Regulatory Science. http://www.cirsci.org/wp-content/uploads/2019/07/RD-briefing-71-Regulatory-trends-in-Latam-final-18719-cl.pdf (accessed September 29, 2019).
PIC/S (Pharmaceutical Inspection Co-operation Scheme). 2017. Standard operating procedure: Procedure for handling rapid alerts and recalls arising from quality defects. https://www.picscheme.org/layout/document.php?id=1140 (accessed September 3, 2019).
PIC/S. 2019a. 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). News Release. https://picscheme.org/en/news?itemid=61 (accessed September 3, 2019).
PIC/S. 2019b. (Switzerland). Press release. PIC/S meetings in Geneva. https://picscheme.org/newsletters/5ce2547c0cf48 (accessed September 3, 2019).
PIC/S. 2019c. Introduction. https://picscheme.org/en/about-introduction (accessed September 30, 2019).
Ratanawijitrasin, S., and E. Wondemagegnehu. 2002. Effective drug regulation: A multicountry study. Geneva, Switzerland: WHO.
Ravinetto, R., H. Tinto, E. Diro, J. Okebe, Y. Mahendradhata, S. Rijal, E. Gotuzzo, P. Lutumba, A. Nahum, and K. J. B. De Nys. 2016. It is time to revise the international good clinical practices guidelines: Recommendations from non-commercial north–south collaborative trials. BMJ Global Health 1(3):e000122.
Rees, V. 2019a. The impact of counterfeit drugs in South and South-East Asia. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/article/92194/the-impact-of-counterfeit-drugs-in-south-and-south-east-asia (accessed September 30, 2019).
Rees, V. 2019b. US and India receive most warning letters from FDA. European Pharmaceutical Review. https://www.europeanpharmaceuticalreview.com/news/97201/us-and-india-receive-most-warning-letters-from-fda (accessed September 30, 2019).
Rönninger, S., S. Schmitt, V. Rangavajhula, E. Hough, and J. Lyda. 2012. Considerations on auditing and GXP requirements along the product lifecycle. PDA Journal of Pharmaceutical Science and 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, and M. J. G. Lumpkin. 2018. Expanding global access to essential medicines: Investment priorities for sustainably strengthening medical product regulatory systems. Globalization and Health 14(1):102.
Saint-Raymond, A. 2019. Mutual recognition agreements and reliance in the regulation of medicines. PowerPoint presentation at the July 10–11, 2019, meeting of the Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines, London, UK.
Schwartz, M. 2017. Another brick in the wall: A new commitment implementing the mutual recognition of inspections. FDA Law Blog, August 24. http://www.fdalawblog.net/2017/08/another-brick-in-the-wall-a-new-commitment-implementing-the-mutualrecognition-of-inspections (accessed September 20, 2019).
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):635–650.
TGA (Therapeutic Goods Administration). 2018. Comparable overseas regulators (CORs) for prescription medicines: Criteria, COR report-based process and worksharing. https://www.tga.gov.au/sites/default/files/comparable-overseas-regulators-cors-prescriptionmedicines.pdf (accessed October 20, 2019).
TGA. 2019a. ACSS–NAS work sharing initiative. https://www.tga.gov.au/acss-nas-work-sharing-initiative (accessed September 15, 2019).
TGA. 2019b. Australia–Canada–Singapore–Switzerland (ACSS) consortium. https://www.tga.gov.au/australia-canada-singapore-switzerland-acss-consortium (accessed September 15, 2019).
UNODC (United Nations Office on Drugs and Crime). 2019. Transnational organized crime in Southeast Asia: Evolution, growth and impact. https://www.unodc.org/documents/southeastasiaandpacific/Publications/2019/SEA_TOCTA_2019_web.pdf (accessed September 30, 2019).
VICH. 2019. What is VICH? https://www.vichsec.org/en/what-is-vich (accessed October 12, 2019).
Vinther, A. 2016. Drug shortage is a “wicked problem.” PDA Letter, May 4. https://www.pda.org/pda-letter-portal/archives/full-article/drug-shortage-is-a-wicked-problem (accessed September 20, 2019).
WHO (World Health Organization). 2009. Handbook: Good laboratory practice (GLP): Quality practices for regulated non-clinical research and development (2nd ed.). https://www.who.int/tdr/publications/documents/glp-handbook.pdf (accessed September 5, 2019).
WHO. 2016a. Collaboration, not competition: Developing new reliance models. WHO Drug Information 30(4):558–566. https://www.who.int/medicines/publications/druginformation/WHO-DI_30-4_RegCollaboration.pdf (accessed September 21, 2019).
WHO. 2016b. Good regulatory practices: Guidelines for national regulatory authorities for medical products. https://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodRegulatory_PracticesPublicConsult.pdf (accessed September 5, 2019).
WHO. 2016c. WHO Zika virus research agenda. https://www.who.int/reproductivehealth/zika/zika-virus-research-agenda/en (accessed September 22, 2019).
WHO. 2016d. Zika virus and complications: 2016 public health emergency of international concern. https://www.who.int/emergencies/zika-virus-tmp/en (accessed September 22, 2019).
WHO. 2017a. China policies to promote local production of pharmaceutical products and protect public health. https://www.who.int/phi/publications/2081China020517.pdf (accessed September 30, 2019).
WHO. 2017b. Prequalification process quality improvement initiatives: 2010–2016. WHO Drug Information 31(3):402–408.
WHO. 2018a. Addressing the global shortage of, and access to, medicines and vaccines. EB142/13. http://apps.who.int/gb/ebwha/pdf_files/EB142/B142_13-en.pdf (accessed September 30, 2019).
WHO. 2018b. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems: Glossary and definitions. https://www.who.int/medicines/regulation/10_GBT_Glossary_RevVI.pdf (accessed September 1, 2019).
WHO. 2019a. Essential medicines and health products: Pharmacovigilance. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en (accessed September 24, 2019).
WHO. 2019b. Essential medicines and health products: Post market surveillance. https://www.who.int/medicines/regulation/ssffc/pms/en (accessed September 24, 2019).
WHO. 2019c. Essential medicines and health products: Prequalification of medicines—capacity building. https://extranet.who.int/prequal/content/capacity-building-0 (accessed September 24, 2019).
WHO. 2019d. Essential medicines and health products: Prequalification of medicines—WHO public inspection reports (WHOPRIS). https://extranet.who.int/prequal/key-resources/prequalification-reports/whopirs (accessed September 24, 2019).
WHO. 2019e. Essential medicines and health products: Why we need strong regulatory systems to reach universal health coverage. https://www.who.int/medicines/news/2019/strong-reg-systems-to-reach-UHC/en (accessed September 24, 2019).
WHO. 2019f. Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce. https://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/guidelines/en/index2.html (accessed September 14, 2019).
WHO. 2019g. Immunization standards: National regulatory authorities. https://www.who.int/immunization_standards/national_regulatory_authorities/role/en (accessed September 24, 2019).
WHO. 2019h. International Conference of Drug Regulatory Authorities. https://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/en (accessed September 14, 2019).
WHO. 2019i. WHO’s approach to promoting reliance. Presentation at the 8th Asia Partnership Conference of Pharmaceutical Associations (APAC), 09 April 2019, Tokyo, Japan. https://apac-asia.com/images/achievements/pdf/8th/5_RA/09_WHO%E2%80%99s%20approach%20to%20promoting%20reliance.pdf (accessed September 24, 2019).
Wilkinson, E. 2019. India and China spark concerns for UK drug supplies. Pharmaceutical Journal 303(7928).
Wilson, B. J., and S. G. Nicholls. 2015. The Human Genome Project, and recent advances in personalized genomics. Risk Management and Healthcare Policy 8:9–20. doi: 10.2147/RMHP.S58728.
Zall Kusek, J., and R. Rist. 2004. Ten steps to a results-based monitoring and evaluation system: A handbook for development practitioners. https://www.oecd.org/dac/peer-reviews/World%20bank%202004%2010_Steps_to_a_Results_Based_ME_System.pdf (accessed September 12, 2019).
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–E678.
