PQDx 0033-013-00 WHO
PQ Public Report
July/2016, version 5.0
PQDx 0053-006-00 WHO
PQ Public Report
June/2016, version 2.0
PQDx 0005-005-00
WHO PQDx PR
May/2016, version 3.0
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 0183‐060‐00 WHO
PQ Public Report
October/2016, version 5.0
PQDx 0006-005-00 WHO
PQDx PR
February/2016, version 2.0
PQDx 0018-010-00 WHO
PQDx PR
July/2016, version 3.0
Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production and inadequate waste disposal in the production of antimicrobials in China and I...ndia, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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PQDx 0198-071-00
WHO PQDx PR
April/2016, version 2.0
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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User satisfaction with assistive devices is a predictor of use and an important outcome measure. This study evaluated client satisfaction with prosthetic and orthotic assistive devices and services in three provinces in the Lao People’s Democratic Republic. Clients were quite satisfied with the as...sistive device and services provided, yet many reported barriers to optimal device use and difficulties in accessing follow-up services. There is a need to examine how prosthetic and orthotic devices can be improved further for better comfort and ambulation on uneven ground in low-resource contexts and to address access barriers.
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Procedures Manual - Medicines registration in Madagascar - 2016 version
In concordance with the global and WHO activities on ARC, the Ministry of Health and Family Welfare (MoHFW) in Bangladesh has come forward and initiative was taken to conduct program for containment of antimicrobial resistance in Bangladesh. Director, Disease Control and Line Director, Communicable ...Disease Control, DGHS was selected as a national focal point to coordinate the national program. Since AMR is a multi-faceted problem, conduction of activities in well-coordinated manner through One Health approach is very important.
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Maldives has made significant strides in the area of infectious disease prevention and control. This is exemplified by elimination of malaria from Maldives in 2015 and successes in TB control. In addition, Maldives is a front runner in infectious disease prevention through successful water, sanitati...on, hygiene and vaccination campaigns and coverage. However, given the limited evidence that exists with respect to the occurrence of resistant organisms in the nation, it is hard to estimate the exact antimicrobial resistance (AMR) scenario. Also, it becomes difficult to compare the current situation with other countries in the region. Moreover, limited evidence exists on the trends of use of antimicrobial agents (AMA) in Maldives. Although, recent prescription audits have indicated overuse of antibiotics, especially for common conditions such as flu, cough and fever.
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Three Years After Enactment of the Drug Quality and Security Act