Regulatory Capacity Building Workshop: Vaccine Clinical Trial Review from Ebola to HIV Regulatory Networks Dr Ahmed Bellah Coordinator Office Regulatory Systems Strengthening [RSS] Regulation of Medicines and Other Health Technologies [RHT] Department of Essential Medicines and Health Products [EMP] World Health Organization E-mail: bellaham@who.int
Regulatory Networks Developing Countries Vaccine Regulator s Network (DCVRN) African Vaccine Regulatory Forum (AVAREF) African Medicines Registration Harmonization Initiative (AMRH) 2
Developing Countries Vaccine Regulator s Network (DCVRN) Establishment: Bangkok, Thailand, 17 September 2004 Mission: to support and promote the strengthening of the regulatory oversight during the development of vaccines, authorization and inspection of clinical trials, evaluation of investigational product and evaluation of registration dossiers in developing countries through expertise and exchange of relevant information. Current members are Brazil, China, Cuba, Indonesia, Iran, South Korea, Thailand and South Africa 3
African Vaccine Regulatory Forum (AVAREF) 4 Establishment: Accra, Ghana, September 2006 To provide information to regulators of countries that are target for clinical trials of HIV, Malaria, Meningitis, TB and other priority vaccines on the different vaccine candidates and timelines for CTs To promote communication and collaboration between NRAs and Ethics committees, among regulators of countries where vaccines are developed and those that are target for the clinical trials and among regulators of the region.
African Medicines Registration Harmonization Initiative (AMRH) a Consortium of partners (3) The overall objective of this project is to achieve a harmonized medicines registration process in countries belonging to the Regional Economic Communities (RECs), based on common documents, processes and shared information systems at the level of Regional Economic Communities (RECs). WHO role in the project is: To provide technical assistance in development and implementation of harmonized approaches for registration of medicines; Support Technical Working Groups in 4 areas: Medicines Evaluation and Registration, Good Manufacturing Practices (GMP), Information management systems (IMS) and Quality Management System (QMS); Support capacity building, training and joint activities. Chairing the Technical Working Group on Regulatory Capacity Development in Africa. 5
What do all the networks aim for? 6
WHO support for medicines regulatory harmonization in Africa: focus on East African Community (1) WHO has promoted harmonization in EAC region through its capacity building component. Regional training on Common Technical Documents (CTD) format and GMP inspections; EAC experts have participated in the WHO Prequalification of Medicines Programme since 2003 Assessment of dossiers submitted to WHO PQ; GMP inspections as observers; Three months rotational post at WHO HQ. 7
Joint WHO/EAC assessment sessions 1 st joint assessment: 2010 2011 Two products Abacavir Sulphate tablets 60mg and Amikacin injection; Outcome - Jointly accepted in January, 2011; Countries approval took place after 3 7 months from the date of joint acceptance by EAC/WHO. 8
Joint WHO/EAC inspections between 2011 and 2013 WHO PQ, Tanzania, Uganda [Site: Kenya] WHO PQ, Kenya, Zanzibar [Site: India] WHO PQ, Uganda, Kenya [Site: India] WHO PQ, Tanzania, Uganda [Two sites: India] WHO PQ, Rwanda [Site: Zimbabwe] WHO PQ, Rwanda, Zanzibar [Site: India] 9
Lessons learnt/achievements from joint activities Capacity (knowledge and skills) built for EAC assessors and GMP inspectors; Quicker access of prequalified and jointly accepted medicines - Reduced timelines for registration ; NMRAs resources saved No duplication of work; Used as a platform for trust building among EAC regulatory experts; Lays foundation for better cooperation among EAC NMRAs future mutual recognition of regulatory decisions among NMRAs. 10
Conclusions Harmonization of regulatory requirements, not anymore a "single-player" activity; Work sharing and collaboration can help reduce workload and improve public health by improving overall regulatory performance. It can help to direct the expert knowledge and resources to performance of the functions that can improve public health and facilitate access to essential medicines; Formation of effective networks and net working the networks may facilitate sharing of scarce resources and eliminate duplicating of activities. 11
WHO/EMP Capacity Building Activities 12
WHO/EMP Capacity Building Activities Objectives Develop an overview of all capacity building activities offered EMP Internally: we learn about each other s work, avoid duplication, improve planning, explore synergies. Externally: Enhances our profile and visibility with stakeholders Work started on the 11 th February and the training data was launched on the 22 nd of may during the WHA 13
Objectives Develop overview of capacity building activities Share knowledge Avoid duplication Improve planning 14
Synergies Policy, Access and Use 6 Access 4 Policy 2 Public Health, Innovation and Intellectual Property 15 Access 3 Local Production 4 Patents 4 Regulatory Practices 4 Regulation of Medicines and other Health Technologies 99 Access 2 Quality 18 Safety & Vigilance 23 Efficacy & product performance 6 GXP Compliance 23 Regulatory Practices 14 Multi-discipline activity 13 15
WHO/EMP Capacity Building Activities To-date 1723 visits to the web page which was launched on the 22 nd of May 2014 http://apps.who.int/prequal/trainingresources/training_emp.mht New page for our Training activities View activities by Area of work and type of training View activities by Area of work and WHO region 16
WHO/EMP Capacity Building Activities View activities by Area of work and type of training View activities by Area of work and WHO region 17