The growing challenges for people in low and middle-income countries to access new medicines.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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PQDx 0179-012-00 WHO
PQDx Public Report
June/2017, version 4.0
Principles and Target Product Criteria. Roadmap January 12, 2015
The Pocket Guide to Managing Contraceptive Supplies addresses one of
the most important components of any program that provides family
planning services—the logistics system that manages the delivery,
quality, and storage of contraceptive supplies. These supplies are
essential; without them, f...amily planning services cannot be provided.
This guide is for the staff of family planning or health clinics who
manage contraceptive supplies and for the supervisor who oversees
these logistics activities. This booklet is not a complete logistics text;
its purpose is to be a quick reference for logistics formulas and
principles to help you manage your supplies (both contraceptives and
other commodities) correctly and efficiently.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
Document No. : FDA/SMC/CTD/GL-CCT/2013/01
WHO/UNICEF/UNFPA joint statement