/regulation-and-prequalification-(rpq)/regulation-and-safety-(reg)/regional-joint-activities-ok.jpg?sfvrsn=e9483608_4 "Polio immunization campaigns in Hargeisa")
Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.
Regional Joint activities and Work sharing
African Medicine Regulatory Harmonization (AMRH) Programme
WHO FPI Team supports the African Medicine Regulatory Harmonization (AMRH) programme by providing technical support to regional economic communities (RECs) joint medicine assessment programs under the initiative. The RECs Joint assessment supports harmonization of medicines regulation and improve access to quality, safe and efficacious medicines in Africa, whilst reducing registration times and enhancing quality registration decisions.
The RECs joint assessments are regional work sharing arrangements where member states conduct scientific reviews of common applications submitted to individual member states or at the relevant secretariat. Within the scope of the support, the WHO FPI team currently provide technical support to Southern African Development Community (SADC) joint assessment procedure (ZAZIBONA) and the East African Community (EAC) joint assessment initiative.
The support provided include optimization of the joint assessment pathways and practices to meet the prescribed timelines, support in development of the tools and review of assessment outcomes to ensure application of international standards, good regulatory practices and good review practices. The main objective is to ensure that outputs of these joint assessments assist the individual member states issue timely marketing authorizations of medicinal quality assured, safe and medicinal products.
ASEAN Joint Assessment
The harmonization of ASEAN pharmaceutical regulations started in 1992 through the establishment of the ASEAN Consultative Committee for Standards and Quality (ACCSQ). In 1999, the ACCSQ established a Pharmaceutical Product Working Group (PPWG) with the objective of developing harmonization of pharmaceutical regulations across ASEAN member countries.
Over the last 20 years, the PPWG has developed a number of important tools to support harmonization and regional cooperation, such as guidelines on bioequivalence, process validation, analytical validation, variation and stability studies which were adopted by all ASEAN Member States.
ASEAN Member States: Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, The Philippines, Singapore, Thailand, and Viet Nam.
In 2015, the PPWG started a WHO-supported project aimed at strengthening the implementation of ASEAN harmonized regulatory requirements (SIAHR). In 2016, the Joint Assessment Coordination Group (ASEAN JACG) was established by the PPWG to focus on activities aimed at intensifying collaboration among ASEAN regulatory authorities (ASEAN NRAs) on product assessment and marketing authorization processes. The ASEAN JACG work operates in the principles of harmonization, collaboration and reliance, and also includes a component of capacity building to ASEAN regulatory authorities. The first ASEAN joint assessment (ASEAN JA) was conducted in July 2017.
List of products recommended through ASEAN JA procedure
It is overwhelming for NRAs at all maturity levels to fulfil all regulatory work alone and independently from other regulators. ASEAN JA is one of the tools, available to countries and companies, that use the concept of collaboration, reliance and work-sharing between ASEAN NRAs, contributing to a more efficient and effective regulatory system in ASEAN countries. Applying ASEAN JA, allow NRAs in the region to make the best with their available resources and time, reducing duplication of regulatory efforts, workload and ultimately accelerating the assessment and registration of their products in the region.
The JACG has developed three main procedural documents to guide the joint assessment processes, encourage applications and assist applicants in the procedures, as well as a JAIMS demo to support the applicants understanding of the electronic platform used for product submissions and information management (Joint Assessment Information Management System – JAIMS). JAIMS demo
More details on ASEAN’s joint assessments can also be found at the ASEAN Secretariat website and respective ASEAN NRAs webpages.