Table 3 Structural and process indicators of legislation and regulation, essential drug selection, and drug registration in Iran in 2002

Is there an official national drug policy document updated in the past 10 years?

Is there drug legislation updated in the past 10 years?

Have regulations based on the drug legislation been issued?

Is there a drug regulatory authority whose mandate includes registration and inspection?

Is there a licensing system to regulate the sale of drugs (wholesalers, pharmacists,...)?

Are pharmacists legally entitled to substitute generic drugs for brand name products?

Are there legal provisions for penal sanctions?

Is there a check-list for carrying out inspections in different types of pharmaceutical establishments?

Are there any institutions where quality control is carried out?

Is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce used systematically?

Are there controls on drug promotion based on regulations and consistent with the WHO Ethical Criteria for Medicinal Drug Promotion?

Is there a national essential drugs list (EDL)/formulary using INN officially adopted and distributed countrywide?

Is there an official drug committee whose duties include updating the national drugs list?

Has the national essential drugs list /formulary been updated and distributed countrywide in the past five years?

Do drug donations comply with the national drugs list?

Are there formal procedures for registering drugs?

Is there a drug registration committee?

Is drug registration renewal required at least every five years?

Number of drug outlets inspected, out of total number of drug outlets in the country.

Number of drug outlets in violation, out of total number of drug outlets inspected.

Number of sanctions and administrative measures implemented, out of total number of violations identified.

Number of advertisements in violation of regulations on the ethical promotion of drugs, out of total number of advertisements monitored.

Number of sanctions implemented for advertisements in violation of regulations, out of total number of violations identified.

Value of drugs from the national drugs list procured in the public sector, out of total value of drugs procured in the same sector.

Number of drugs from the national drugs list prescribed, out of total number of drugs prescribed.

Number of drugs from the national drugs list sold, out of total number of drugs sold.

Number of locally manufactured drugs sold in the country from the national drugs list, out of the total number of drugs from the national drugs list.

Number of combination drugs newly registered, out of total number of newly registered drugs.

Number of registered drugs, which are banned in other countries, out of total number of registered drugs.