UNITED STATES PHARMACOPEIA
The Building Regional Expertise in Medicines Regulation, Information-sharing, Joint Investigation, and Enforcement (BREMERE) initiative was launched in 2012 with the goal of strengthening regional cooperation between medicines regulatory authorities and law enforcement agencies in the Greater Mekong Subregion (GMS) to improve the quality of medicines.
2012 · 44 pages

Abstract
The initiative aims to build capacity through sharing of regional expertise and provision of training and technical/financial support to create a regional "pool of experts" who will share information and expertise in medicines regulation, registration, post-marketing surveillance, and enforcement. Representatives from the relevant authorities of Cambodia, Laos, Thailand, Vietnam, Philippines, and Indonesia, as well as international and scientific organizations, participated in the inaugural meeting held in Bangkok, Thailand, on August 28-29, 2012. The meeting focused on the challenges faced by individual countries in tackling the problem of counterfeit and substandard medicines, particularly with inter-sectoral and inter-country cooperation. The Promoting the Quality of Medicines program, Worldwide Antimalarial Resistance Network (WWARN), Mahidol and Chulalongkorn Universities, and the U.S. Department of State Lower Mekong Initiative (LMI) shared their experiences in providing assistance in the field. The Terms of Reference (TOR) drafted by the group encompassed BREMERE's governance, coordination, implementation, and complementarity with other similar efforts. By the end of the meeting, participants successfully reached a consensus on the TOR, leadership of the initiative, and a timeline for future activities. The agreed-upon BREMERE objectives include building capacity through sharing of regional expertise and provision of training and technical/financial support, strengthening support and collaboration in the field of medicines quality and regulation, and improving information sharing, collective investigation, and enforcement processes among regulatory/technical agencies and other sectors involved. The BREMERE initiative is funded by USAID/Regional Development Mission for Asia through the President's Malaria Initiative. The initiative aims to improve the quality and safety of medicines globally by providing technical assistance to developing countries to build local capacity in medicines quality assurance systems, increase the supply of quality medicines to priority USAID health programs, and ensure the quality and safety of medicines globally. The meeting report highlights the importance of regional cooperation in addressing the challenges posed by counterfeit and substandard medicines. The report also emphasizes the need for a coordinated approach to improve the quality and safety of medicines in the GMS region. The BREMERE initiative is a significant step towards achieving this goal, and its success will depend on the continued cooperation and commitment of the participating countries and organizations. The initiative's objectives are aligned with the goals of the World Health Organization (WHO) and the United States Pharmacopeia (USP), which aim to improve the quality and safety of medicines globally. The BREMERE initiative is also consistent with the principles of the Asian Network of Excellence for the Quality Assurance of Medicines (ANEQAM) and the Association of South East Asian Nations (ASEAN) Pharmaceutical Products Working Group (ASEAN PPWG). The meeting report acknowledges the contributions of various individuals and organizations that participated in the meeting, including representatives from the WHO, INTERPOL, USAID, and the U.S. Department of State. The report also expresses gratitude to the administrative and editorial staff of the Promoting the Quality of Medicines program for their assistance in preparing the report.
Classification
USAID DEC