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As vaccines get approved by national authorities, learn about National and WHO approval processes for vaccines and how safety is ensured during emergency approval of vaccines. Dr Mariângela Simão ... more
DOI: 10.5772/intechopen.102891Little progress has been made since the 1960s and 19. 70s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and opera ... more
The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those ... more
4th edition. This report – now in its fourth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurposed drugs. We provide detailed pricing profiles of key DR-TB drugs, using manufacturer responses to s ... more
Act 9 of 2016
Document No. : FDA/SMC/CTD/GL-CCT/2013/01
As vaccines get approved by national authorities, learn about National and WHO approval processes for vaccines and how safety is ensured during emergency approval of vaccines. Dr Mariângela Simão ... more
Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure ... more
COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h ... more
HIV/AIDS Programme
Guidance for the preparation and submission of dossiers
STP Guidelines, First Edition 2017