Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities
Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities

Author: World Health Organization

Publisher: World Health Organization

Published: 2023-11-14

Total Pages: 44

ISBN-13: 9240074767

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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
Evaluating and publicly designating regulatory authorities as WHO listed authorities: policy document

Author:

Publisher: World Health Organization

Published: 2021-06-14

Total Pages: 20

ISBN-13: 9240023445

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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.

Manual for performance evaluation of regulatory authorities seeking designation as WHO-listed authorities
Manual for performance evaluation of regulatory authorities seeking designation as WHO-listed authorities

Author: World Health Organization

Publisher: World Health Organization

Published: 2023-11-14

Total Pages: 272

ISBN-13: 9240076964

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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.

Guidance on development and implementation of a national deployment and vaccination plan for vaccines against pandemic influenza and other respiratory viruses of pandemic potential
Guidance on development and implementation of a national deployment and vaccination plan for vaccines against pandemic influenza and other respiratory viruses of pandemic potential

Author: World Health Organization

Publisher: World Health Organization

Published: 2023-12-11

Total Pages: 122

ISBN-13: 9240084878

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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.

Government Auditing Standards - 2018 Revision
Government Auditing Standards - 2018 Revision

Author: United States Government Accountability Office

Publisher: Lulu.com

Published: 2019-03-24

Total Pages: 234

ISBN-13: 0359536395

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Audits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.

WHO Expert Committee on Specifications for Pharmaceutical Preparations
WHO Expert Committee on Specifications for Pharmaceutical Preparations

Author:

Publisher: World Health Organization

Published: 2021-04-26

Total Pages: 324

ISBN-13: 924002090X

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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.

How to Develop and Implement a National Drug Policy
How to Develop and Implement a National Drug Policy

Author: World Health Organization

Publisher: World Health Organization

Published: 2001

Total Pages: 104

ISBN-13: 9789241545471

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A drug policy is a crucial ingredient in every country's national health strategy as it provides a strategic framework to identify goals and commitments. This publication discusses the key components of such a policy. Issues covered include: the selection of essential drugs, affordability; finance and supply; regulation and quality assurance; rational use; research; human resources; monitoring and evaluation.

Guide for All-Hazard Emergency Operations Planning
Guide for All-Hazard Emergency Operations Planning

Author: Kay C. Goss

Publisher: DIANE Publishing

Published: 1998-05

Total Pages: 277

ISBN-13: 078814829X

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Meant to aid State & local emergency managers in their efforts to develop & maintain a viable all-hazard emergency operations plan. This guide clarifies the preparedness, response, & short-term recovery planning elements that warrant inclusion in emergency operations plans. It offers the best judgment & recommendations on how to deal with the entire planning process -- from forming a planning team to writing the plan. Specific topics of discussion include: preliminary considerations, the planning process, emergency operations plan format, basic plan content, functional annex content, hazard-unique planning, & linking Federal & State operations.