Vaccine needs in the Islamic Republic of Iran are primarily met through local production by two main vaccine producers; the Pasteur Institute of Iran and the Razi Vaccine and Serum Research Institute, each established over 70 years ago. The Pasteur Institute supplies the entire national demand for BCG, while Razi supplies the other vaccines for the Expanded Programme on Immunization (OPV, DTP, DT, Td, measles). The Act for Food, Beverages, Pharmaceuticals and Medical Devices, issued in 1955 (Act 1334) and later amended in 1967 and 1988, defines the scope and responsibilities of the MOHME as official national regulatory authority supervising the production of vaccines, as well as the function and responsibilities of an advisory and decision-making committee. As part of the WHO vaccine prequalification process, WHO has conducted four formal assessments to document recommendations to strengthen the Iranian vaccine regulatory system (1997, 2002, 2004 and 2006), and seven follow-up visits during the same period. This is the first step towards the prequalification of vaccines by WHO.
In 2010, upon the request of the Ministry of Health and Medical Education (MOHME), WHO visits were organized to assess the vaccine regularity system. The WHO Missions advised the MOHME to initiate and complete several and pending activities in order to be ready for the formal NRA assessment. Based on WHO assessment most of the regulatory function had achieved a score that ranged from 83% to 97%. This includes the Post marketing Surveillance including Adverse Events Following Immunization AEFI/PMS function; NRA lot release function; the Regulatory Inspection function; and the Oversight of Clinical Trials function. According to WHO visits, the progress of National Regulatory Authority in Iran is ahead of other countries in the region and by the end of 2013, NRA of Iran would have been strengthened based on WHO assessment criteria
