History and features of Reference Drugs

Russian pharmaceutical market demonstrates rapid development resulting in drugs manufacture localization; this is explained by the course of the Russian government to substitute and decrease the proportion of the imported drugs. Also, the dynamics of the Russian pharmaceutical market development is progressive. This leads to constant increasing value and importance of reference and generic drugs.

When the term Reference Drug came in use?

The term became widely used several years ago, mainly in 2015, when Federal Law #61 “On Drugs’ Circulation” (hereinafter “the Law”) was amended. Before the amendment, pharmaceutical drugs were divided into original and generic drugs. Original drugs are those synthesized for the first time, and their safety and efficacy profiles are to be confirmed by full-scale clinical trials. Generic drugs are those having similar dosage forms and substance to the original drugs. These drugs were typically marketed later than original ones.

Reference drug is the drug being marketed in Russia for the first time. Its safety and efficacy profiles are to be confirmed by preclinical and clinical trials.

Many professionals disliked the existing terms and treated them as trade terms rather than official and applicable for legal documents regulating the field. The amended Law harmonized the terms. The terms “Original drug” and “Comparator” are replaced with the single term “Refence drug”.

The term “Generic Drug” is still actual. The term implies the drug with the active ingredients formulated in the same quantity and proportion as in the reference drug. On top of that, their safety and efficacy profiles are to be confirmed by scientific research, clinical studies and analytical tools.

Favorable perspectives

Such amendments and addendums stabilize and favor and develop Russian pharmaceutical legislative system. Legislative acts and laws contribute to new initiatives of the pharmaceutical companies and new drugs appearance.

Also, it is noteworthy that systematic legislation improvement and new subsidizing measures, and preferential governmental support for specific manufacturing companies, results in competition stimulation. Organizations compete each other, improving the products quality, which also makes a good advantage for the market.