Islamic Republic of Iran | Programme areas | Pre-qualification of medicines programme

Pre-qualification of medicines programme

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WHO's prequalification of medicines programme was established to facilitate access to medicines that meet unified standards of quality, safety and efficacy measures.

The programme ensures medicine quality through:

  • implementing a performance management system and good manufacturing practices
  • drawing up a new pharmacopoeia
  • enforcing a branded generic naming system
  • establishing a centre for registration
  • reviewing of adverse drug reactions.

Other measures include implementation of a quality assurance system, registration of products by companies and conducting bioequivalence tests.

The Food and Drug Organization in the Ministry of Health and Medical Education is officially in charge of policy-making and ensuring sustainability of supply for essential and other medicines.

Pharmaceutical companies in Islamic Republic of Iran are now privately owned and managed. For the past 15 years, local companies have been producing 95% of all local needs for medicines and there are now more than 8000 pharmacies in the country. Local companies produce 1200 items and the Ministry of Health and Medical Education has issued more than 3800 production licenses to manufacturers.

Vaccines

Vaccine needs in the Islamic Republic of Iran are primarily met through local production by two main vaccine producers: the Pasteur Institute 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 Ministry of Health and Medical Education as the 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 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 WHO conducted an assessment of the vaccine regularity system. The WHO assessment gave the regulatory functions scores that ranged from 83% to 97%. This included post-marketing surveillance, including adverse events following immunization; national regulatory authority lot release; regulatory inspection; and oversight of clinical trials.

The progress of the National Regulatory Authority in Islamic Republic of Iran is ahead of other countries in the Region and by the end of 2013, the national regulatory authority will have been strengthened based on WHO assessment criteria.

Related link

Essential medicines and health products

Regional essential medicines and pharmaceutical policies

Vaccines health topic

Key health-related statistics

Total population in thousands

79 926

Total health expenditure (as % of general government expenditure)

17.5

Maternal mortality per 100 000 live
births

25

Primary health care units and centres

2.8

Life expectancy

75.5

Source: Country statistical profiles (2017)

Islamic Republic of Iran country health profile

Regional Health Observatory