Igor Zupanets

Doctor of Medical Sciences, Professor, Head of the Department of Clinical Pharmacology and Clinical Pharmacy of the National University of Pharmacy, Head of the Problem Commission "Clinical Pharmacology and Clinical Pharmacy" of the Ministry of Health and the National Academy of Medical Sciences of Ukraine.

Dec 26, 2018

“Orange Book”: protection of responsible manufacturers and consumers

A new Directory on drug equivalence, “Orange Book”, developed by the Department of Clinical Pharmacology and Pharmacy of the National University of Pharmacy, will be published in Ukraine.


The first Directory on drug equivalence, or the Ukrainian “Orange Book”, was published in 2016; the second – in 2017. This Directory contains all relevant information for pharmacists, physicians, pharmaceutical sales representatives and patients regarding proven efficacy of medicinal products authorized and marketed in Ukraine. A special classification approved by the Ministry of Health of Ukraine was developed for the Directory.

According to the laws of any country, including Ukraine, only medicinal products with proven efficacy and safety may be marketed. How can this be confirmed? How can one be sure that the drug is safe and underwent all study procedures to prove its efficacy and safety? We asked all Ukrainian and foreign manufacturers that market their medicines in Ukraine to provide information about their products and procedures according to which they are registered. If a drug is registered under complete procedure, this is an innovative, original product. If this is a generic, then it is necessary to ascertain, how bioequivalence was verified: in vivo or in vitro. Many manufacturers provided us with this information and we published it in the Directory with their consent. However, some manufacturers refused to provide such data for their own reasons. Why? I am not sure. However, when one has something to be proud of, one would talk about it.

The “Orange Book” contains a list of innovative and generic medicines with FDA assessment of therapeutic equivalence and was first published in the United States in the late 1970s.

This directory is not a regulatory document, although for the Ministry of Health this is a completed product, which may be qualified as a state formulary, a state data compendium. Accordingly, the Ministry may use it to oblige manufacturers to submit the corresponding information. Incidentally, the relevant draft law has been submitted to the Verkhovna Rada of Ukraine and is primarily aimed at protecting responsible manufacturers.

In the US, a similar directory is published annually. Companies are obliged to report the basis, on which manufacturers register their medicinal products. Information about the study procedures is not confidential around the world, including in Ukraine, effective from 04.09.2018, after the update of the relevant clause of Article 9 of the Law “On Medicines”. At the same time, the European countries went further. If manufacturers announce preclinical or clinical studies, they must publish them, regardless of the results. Even if the medicinal product is not bioequivalent, the manufacturer must publish this information.

The main function of “Orange Book” is educational. We must protect our market, our consumers. Patients should know what medicines they take, how manufacturers take care of their products, whether they have proven efficacy or not. Doctors should be conversant. I would recommend doing so. If there is an index opposite the drug name, it can be administered. If not, preference should be given to those, which have such index.


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