Dr A. Kebriaeezadeh, Islamic Republic of Iran

Blood products are regulated by the Iranian Blood Transfusion Organization (IBTO) and the National Regulatory Authority (NRA), both of which belong to the Ministry of Health.

Blood products may be either locally manufactured or imported. All such products need to be registered and approved by the NRA for marketing. An establishment licence issued by the NRA is needed by manufacturers, importers and distributors. The NRA is also responsible for conducting batch release testings. Documentation and other requirements for registration are very similar for locally made and imported product, and include the site master file, drug master file, GMP certificate. A CPP (certificate of a pharmaceutical product) from the country of origin and a list of countries where the product is registered and/or marketed are also required.

In the Islamic Republic of Iran, manufacturers of blood products must have an establishment licence for their production facility. Most importantly, before a marketing authorization for blood products can be granted, a rigorous review of their safety, quality and efficacy by the NRA is essential.