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FIP Foundation

FIP Foundation for Education and Research

 

FIP Regulators Advisory Group

Pharmacy regulation

Organisations involved in regulating pharmacy education or pharmacy premises (as opposed to medicine regulations) play a fundamental role in setting standards of practice, ethical conduct, and protecting the public by assuring workforce competence and capability, sustained performance, and, where applicable, the scope of practice for pharmacists and all registered practitioners.

Their role in society is to ensure patient safety and optimal health outcomes. Given their public interest function, membership of professional bodies that advocate and promote the profession is often inappropriate (and in many cases not allowed). However, due to the importance of these regulatory bodies to the pharmacy profession, it is essential for FIP to collaborate and engage with such organisations even if they cannot be members.

Following the signing of the Astana Declaration in October 2018, that affirmed pharmacy’s role in advancing universal health coverage through primary health care, it became essential for FIP to focus on areas of practice that would focus our impact on primary healthcare through NCDs, safety and prevention. Two enabling areas were provided by establishing two ONE-FIP forums in 2019, to gather groups and experts around technology and regulations. The second ONE FIP Regulators forum brought regulatory bodies together to provide a forum for mutual learning, advice and sharing of priorities. Following the move to integrate the regional forums into FIP, these ONE FIP forums have evolved into advisory groups for pharmacy professional regulators to advise FIP and enable FIP to support regulators on emerging needs and developments.

Mission and objectives

The mission of the FIP Regulators Advisory Group is to provide expertise and advice to FIP on matters related to pharmacy regulation. The group of pharmacy professional regulators seeks to share best practices, discuss emerging trends, and address the evolving needs of the profession and its regulations, thereby contributing to public protection and the achievement of optimal health outcomes through a competent and adequately regulated pharmacy profession at national, regional, and global levels.

The main objectives of the FIP Regulators Advisory Group are:

  • To provide expertise and advice to FIP on matters related to pharmacy regulation. This expertise can be offered for specific events or issues as needs emerge.
  • To contribute to FIP’s mission of advancing pharmacy worldwide by providing expertise, advice, and support on regulations, regulatory standards, and processes in education, premises, and pharmacy matters.
  • To offer a forum for pharmacy professional regulators to discuss challenges and share best practices.
  • To share best practices related to public protection and the roles of regulators in this area.
  • To support the advancement of pharmacy regulation worldwide in a coordinated and collaborative manner.
  • To provide an advisory group for FIP members with regulatory roles and to create a platform for organisations with regulatory roles to engage, share, and advise.
  • To inform strategies for workforce capability and competence within an international framework.
  • To share evidence on pharmacy regulatory practices worldwide and to use this evidence to inform policy and guide the activities of the Advisory Group.
  • To advise the FIP Council, Bureau, and Executive Committee on matters related, but not exclusive to Professional regulations, professionals (e.g., pharmacists, technicians, supportive staff, student interns), and the practice of pharmacy, including the dispensing of medicines and medical devices, and facilities (e.g., pharmacies, distributors) within a regulatory entity’s scope.

Members

The advisory group in 2025 is co-chaired by Mr Brett Simmonds, Pharmacy Guild of Australia (Australia) and Dr Naoko Arakawa, FIP Bureau Interim Education Secretary (UK).

The members of the group include:

  • Mr Diogo Morim, Portugese Pharmaceutical Society (Portugal)
  • Dr Al Carter, National Association of Boards of Pharmacy (USA)
  • Ms Carine Wolf-Thal, French Chamber of Pharmacists (France)
  • Mr Greg Eberhart, National Association of Pharmacy Regulatory Authorities (Canada)
  • Ms Raquel Martínez, General Pharmaceutical Council of Spain (Spain)
  • Mr Dan Burns, Pharmaceutical Society of Ireland (Ireland)
  • Mr Ronald Guse, National Association of Boards of Pharmacy (USA/Canada)

Would you like to join the group? Membership of the Advisory Group is open to any organisation that meets the following description:"ministries or organisations that regulate, inspect and/or accredit pharmacy practice, including education, for the protection of the public." Membership is organisational, not individual.

Some organisations may combine regulatory functions with other roles, such as advocacy or negotiation. Such organisations may join the Advisory Group to collaborate on issues related to professional regulation.

The Advisory Group may also invite and engage with organisations that are not FIP Member Organisations, when these may be unable to join due to public mandates that prevent them from joining FIP. Find more information about FIP membership and further member benefitshere.

Activities and resoucres

Useful resources developed by the group include:

Pharmacy led vaccination services: Regulatory self-assessment and implementation tool
   
 This self-assessment tool, developed by the group, aims to help countries self-assess readiness of their regulations to enable pharmacist-delivered vaccination services and, where needed, to implement such regulations. This resource covers the broad pharmacist-led roles related to vaccination from supply chain management to administration and prescribing. You may access the toolhere.

Pharmacy-based pandemic vaccination programme: Regulatory self-assessment tool

This self-assessment tool, developed by the group, helps to identify strengths and areas for improvement in order to inform pandemic planning efforts ahead of current and future waves of COVID-19. It is an aid to help national ministries of health and regulators in assessing pandemic preparedness and the state of legislation and regulations within their countries to facilitate mass vaccination and testing and enhanced patient care through pharmacists and community pharmacies. Access the tool here in English. Translation is available in FrenchSpanish and Portuguese.

Management of non-communicable diseases: Regulatory self-assessment and development tool for transforming pharmacy practice

Regulators, ministries of health, policymakers and national pharmacy organisations are encouraged to assess regulations in their country related to pharmacy-based care of non-communicable diseases (NCDs) with a development tool developed by FIP's Forum of Pharmacy Professional Regulators. This tool is based on experiences from countries where pharmacy services targeting NCDs (including testing, measurement of parameters, such as blood pressure and peak expiratory volume, and prescribing or modifying prescriptions) have been successfully introduced and regulated, and on researched pharmacy practice legislation from around the world. You may access the toolhere.

Substandard and falsified medical products: Regulatory self-assessment tool

 This regulatory self-assessment tool seeks to aid the detection of, quarantine and removal of substandard and falsified (SF) medical products from the pharmaceutical supply chain in a country and to prevent SF medical products from being used by patients. It also includes SF medical products incident information sharing and public awareness. The self-assessment tool identifies the role of ministries of health, and FIP intends that this regulatory framework be adopted for other healthcare professions and become applicable to all healthcare workers. Access the tool here, also available inFrenchPortuguese andSpanish

Upcoming events

The FIP Regulators Advisory Group is organising a session relevant to regulators at theFIP World Congress on Pharmacy and Pharmaceutical Sciences in Copenhagen, Denmark, which will be held from 31 August to 3 September 2025. The session entitled “Find Your Digital Health Zen: How to Digitally Innovate with Care” seeks to enhance the awareness of the impact of digital health on practice and delve into the regulatory and ethical obligations of pharmacists when employing digital health tools in their professional settings.

Please contact Ms Paula Cohen for more information about the Regulators Advisory Group atpaula@fip.org

Last update 3 April 2025

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