Operational Guidance For Evaluating And Publicly Designating Regulatory Authorities As Who Listed Authorities
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Operational Guidance For Evaluating And Publicly Designating Regulatory Authorities As Who Listed Authorities
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-11-14
Operational Guidance For Evaluating And Publicly Designating Regulatory Authorities As Who Listed Authorities written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-14 with Medical categories.
The Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities provide procedural information (processes, steps and timelines) and general considerations related to the evaluation and listing of a regulatory authority as a WHO-listed authority (WLA). The guidance also describes the process and criteria for renewal, re-evaluation and possible delisting, the role and responsibilities of the technical advisory group on WLAs (TAG-WLA) and the undertakings of WHO and eligible regulatory authorities.
Evaluating And Publicly Designating Regulatory Authorities As Who Listed Authorities Policy Document
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Author :
language : en
Publisher: World Health Organization
Release Date : 2021-06-14
Evaluating And Publicly Designating Regulatory Authorities As Who Listed Authorities Policy Document written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-06-14 with Medical categories.
This policy on the evaluation and designation of regulatory authorities as WHO listed authorities (WLA) was developed following broad public consultation and the review of written comments received from the publication of a concept note, which informed the drafting of a first version of the WLA policy and operational guidance, as well as international consultative meetings with Member States and interested stakeholders. It also considers recommendations from the fifty-second meeting of the World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) on the replacement of the term “stringent regulatory authority” with “WHO listed authority”. The ECSPP recommendations were based on comments received on the proposed elements of a replacement definition for Stringent Regulatory Authorities (SRAs) posted by WHO for public comment in August 2017 that was intended to provide a more transparent, robust and equitable measure of regulatory performance.
Guidance On Development And Implementation Of A National Deployment And Vaccination Plan For Vaccines Against Pandemic Influenza And Other Respiratory Viruses Of Pandemic Potential
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-12-11
Guidance On Development And Implementation Of A National Deployment And Vaccination Plan For Vaccines Against Pandemic Influenza And Other Respiratory Viruses Of Pandemic Potential written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-11 with Medical categories.
Vaccines are powerful weapons in the fight against pandemic viruses as shown by responses to both the 2009 H1N1 influenza and the COVID-19 pandemics. However, planning for accessing, allocating and deploying vaccines in a pandemic situation is a complex endeavour, beset with multiple challenges at all levels – local, regional and global. The World Health Organization (WHO) and its partners have prepared this revised guidance document to assist countries update their national deployment and vaccination plans (NDVPs) by leveraging global learnings from past pandemic responses, including the recent COVID-19 vaccination effort. The development and testing of a NDVP would not only advance pandemic preparedness efforts but would also have benefits in terms of increasing national capabilities to manage other health emergencies which require emergency vaccination campaigns.
Manual For Performance Evaluation Of Regulatory Authorities Seeking Designation As Who Listed Authorities
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-11-14
Manual For Performance Evaluation Of Regulatory Authorities Seeking Designation As Who Listed Authorities written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-14 with Medical categories.
This manual provides operational and technical details for the performance evaluation (PE) exercise that must be conducted for a regulatory authority (RA) to achieve listing as a WHO-listed authority (WLA) in relation to each regulatory function. The PE manual should be read in conjunction with the Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities (“The Operational Guidance”). For the purposes of this document the term regulatory authority (RA), unless otherwise stated, may refer to either a national regulatory authority (NRA) or a regional regulatory system (RRS). The basis for designation as a WLA is provided by the Global Benchmarking Tool (GBT), which is complemented by a series of PE activities designed to establish a detailed picture of how the regulatory system performs on relevant regulatory processes, including how consistently it adheres to quality procedures and how well it delivers the desired regulatory outputs in accordance with good regulatory practices.
Who Expert Committee On Specifications For Pharmaceutical Preparations
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2022-12-22
Who Expert Committee On Specifications For Pharmaceutical Preparations written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-22 with Business & Economics categories.
Who Expert Committee On Specifications For Pharmaceutical Preparations
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Author :
language : en
Publisher: World Health Organization
Release Date : 2021-04-26
Who Expert Committee On Specifications For Pharmaceutical Preparations written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-26 with Medical categories.
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. Standards are developed by the Expert Committee through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations; Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation; Good manufacturing practices: water for pharmaceutical use; Guideline on data integrity; WHO/United Nations Population Fund recommendations for condom storage and shipping temperatures; WHO/United Nations Population Fund guidance on testing of male latex condoms; WHO/United Nations Population Fund guidance on conducting post-market surveillance of condoms; WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce; Good reliance practices in the regulation of medical products: high-level principles and considerations; and Good regulatory practices in the regulations of medical products. All of the above are included in this report and recommended for implementation.
Who Pharmaceuticals Newsletter
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2022-09-30
Who Pharmaceuticals Newsletter written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-09-30 with Medical categories.
Quality Assurance Of Pharmaceuticals A Compendium Of Guidelines And Related Materials Tenth Edition Volume 1 Good Practices And Related Regulatory Guidance
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2024-10-24
Quality Assurance Of Pharmaceuticals A Compendium Of Guidelines And Related Materials Tenth Edition Volume 1 Good Practices And Related Regulatory Guidance written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-24 with Business & Economics categories.
This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.
Who Guideline On Balanced National Controlled Medicines Policies To Ensure Medical Access And Safety
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2025-07-23
Who Guideline On Balanced National Controlled Medicines Policies To Ensure Medical Access And Safety written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-07-23 with Law categories.
Access to medicines is essential for attainment of universal health coverage, which is central to achievement of the health-related Sustainable Development Goals. Controlled medicines include those such as opioids, benzodiazepines, barbiturates, amphetamines and others with identified or emergent clinical indications. WHO recognizes that these medicines are necessary for pre- and post-operative care, for sedation, for the management of both acute and chronic pain, for palliative care, as anticonvulsants (anti-epileptics), for the management of anxiety disorders and for the management of substance use disorders, including as opioid agonist therapy (OAT). The purpose of this guideline is to assist WHO Member States and their partners in developing and implementing balanced national controlled medicines policies to ensure their accessibility, availability and affordability for medical and scientific uses and to minimize the risk of harm arising from non-medical use. The guideline addresses policies for groups (of all ages, from neonates through to older people) affected by conditions in which use of controlled medicines is deemed to be medically appropriate according to evidence-based clinical practice guidelines.
Who Drug Information
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Author :
language : en
Publisher: World Health Organization
Release Date : 2021-04-08
Who Drug Information written by and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-08 with Medical categories.