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Publication Years
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2716
454
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3
Category
1626
472
330
322
307
98
96
1
Toolboxes
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232
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189
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1
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
PMPB/INS-GUIDE/04
PMPB/INS-GUIDE/02
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and
...
Registration (MER) of the East African Community Medicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
more
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availa
...
bility Monitoring Mobile Application. This tool facilitates rapid and inexpensive data collection at the facility level.
more
Essential Medicines and Health Products Information Portal
WHO PQS Devices Catalogue. Pre-qualified equipment for the Expanded Programme on Immunization (EPI)
recommended
The PQS on-line catalogue includes details of all immunization-related products currently pre-qualified by WHO for procurement by United Nations agencies. The catalogue is produced and maintained by the Quality, Safety and Standards group in the Imm
...
unization, Vaccine and Biologicals Department of WHO, Geneva. It replaces the old WHO/UNICEF Product Information Sheets (PIS), the last edition of which was published in 2000. Only products included in the PQS catalogue are now recommended to be purchased by UN agencies.
Large File: 120 MB
more
Guidelines for the production of extemporaenous formulations and hospital based sterile preparations
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guide
...
lines therefore is to assist pharmacists in discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
more
This Medical Product Alert relates to the recent circulation of two confirmed falsified versions of Quinine
Sulphate circulating in Cameroon and the Democratic Republic of the Congo, containing zero active
pharmaceutical ingredient
The second edition of the joint WHO, WIPO and WTO
publication “Promoting Access to Medical Technologies
and Innovation: Intersections between public health,
intellectual property and trade” (the Trilateral Study),*
...
published in 2020, included a special insert mapping the
challenges posed by the COVID-19 pandemic in relation
to the integrated health, trade and IP policy framework set
out in the study. The Trilateral Study and the special insert
were designed to serve as background reference for policy-
makers in the widest sense – lawmakers, government
officials, delegates to international organizations, non-
governmental organizations (NGOs) and researchers
who seek a comprehensive presentation of the full range
of issues, including institutions and legal concepts with
which they may be unfamiliar. It is also designed to serve
as a factual resource for the three organizations’ technical
cooperation activities.
This update revises the information contained in that
insert in the light of more recent developments as of
30 August 2021. Further updates will be made to reflect
subsequent developments.
more
This publication is based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring and end of life care. This publication addresses medical devices for six ty
...
pes of cancer: breast, cervical, colorectal, leukemia, lung and prostate. The first section defines the global increase in cancer cases, the global goals to manage NCDs and the WHO activities related to these goals. The second section presents the methodology used for the selection of medical devices that support clinical interventions required to screen, diagnose, treat and monitor cancer stages, as well as the provision of palliative care, based on evidence-based information. The third section lists the priority medical devices required to manage cancer in seven different units of health care services: 1. Vaccination, clinical assessment and endoscopy, 2. Medical imaging and nuclear medicine, 3. Surgery, 4. Laboratory and pathology, 5. Radiotherapy, 6. Systemic therapy and 7. Palliative and end of life care
more
Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availa
...
bility Monitoring Mobile Application. This tool facilitates rapid and inexpensive data collection at the facility level.
more
