Registration of active pharmaceutical ingredients in Russia

In recent years since 1992, the production of domestic-made active pharmaceutical ingredients in the Russian Federation has been steadily declining, and by 2004 it has reduced by 6.3 times. According to the data provided by experts, in 2013-2014 Russia, in monetary terms, imported 80% of its active pharmaceutical ingredients from Germany, France, Italy, and China.  To fully implement the Pharma 2020 Federal Target Program, we desperately need these domestic-made active pharmaceutical ingredients, hence, in recent years special attention has been paid to the internal development and production of such ingredients in Russia. Nevertheless, even in 10-15 years we cannot expect that Russian pharmaceutical ingredients will be a commercially viable alternative to the products produced in India and China, the world factories of active pharmaceutical ingredients, who supply large volumes of ingredients to companies all over the world.  Hence, now Chinese and Indian companies are extremely interested in registering their active ingredients in the Russian Federation and eager to supply their active pharmaceutical ingredients to pharmaceutical plants in Russia.

Since 2016, a new ingredient registration rule has been implemented: the ingredient manufacturer shall have the Russian equivalent of a GMP Certificate for the ingredient production plant.
The registration of active pharmaceutical ingredients in Russia is made in two ways:

1. The registration of a pharmaceutical ingredient as a part of a finished medicinal product. In other words, the ingredient is supplied to a single plant for the production of a specific medicinal product and cannot be used to produce other drugs. In addition, the active pharmaceutical ingredients used in the production of the finished medicinal product are subject to quality assessment during the registration procedure of the finished medicinal product.
2. The registration of the ingredients imported into Russia for sale to several plants for the production of finished medicinal products.

In the first case the active pharmaceutical ingredient is not registered, which means that this ingredient is not added to the Russian Federation State Register of Drugs .
In the second case the registration of the active pharmaceutical ingredient takes place in full, and the registered ingredient is added to the Russian Federation State Register of Drugs . Following this procedure this pharmaceutical ingredient can be used in finished medicinal products, in other words, manufacturers can use it for the production of finished drugs. Thus, the ingredient shall have the GMP Certificate issued by the Russian agency (link to GMP certification services in Russia and the European Union).
The registration of the pharmaceutical ingredients consists of three stages.

1. The preparation of the manufacturing site profile and its submission to the Russian Federation Ministry of Industry and Trade for inspection of the active pharmaceutical ingredient manufacturing plant for compliance with GMP standards according to the requirements approved by Decree No. 1314 of the Russian Government as of 03 December 2015.
2. The preparation of the active pharmaceutical ingredient registration profile and its submission for registration to the Russian Federation Ministry of Healthcare. At this stage the MOH laboratory performs quality control testing of the active pharmaceutical ingredient and issues the certificate.
3. The pharmaceutical ingredient inclusion in the Russian Federation State Register of Drugs, which is the equivalent to the issuance of a registration certificate.

The registration period for active pharmaceutical ingredients in Russia is 5-6 months, excluding the GMP certification terms.