Eurasian Economic Union Discussing Single Pharmaceutical Regulator
- Positive implications for Chinese TCM and Indian Pharma if FTA details can also be worked out
The Eurasian Economic Commission (EEC) is discussing the creation of a single regulator for the circulation of medicines in the Eurasian Economic Union (EAEU). The EAEU includes Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia and has free trade agreements with an increasing number of Asian countries. China has signed an FTA yet is still working out tariff reduction details, while India, the world’s largest drug manufacturer is currently negotiating an FTA with the EAEU. Singapore and Vietnam already have FTA with the EAEU with Indonesia and Thailand also close to completing negotiations.
Proposals to create a common regulator have been initiated by members of the working group on the formation of common approaches to regulating the circulation of medicines in the EAEU. This was done as part of the development of a draft concept for the further development of common markets for drugs and medical devices in the Union. The proposals will be discussed by all EAEU states until an agreed position on this issue is developed, the EEC specified.
The decision to create a unified regulatory body for the EAEU is made at the level of the heads of state of the association and will require changes to the 2014 Union Treaty.
In Russia, from January 1, 2021, new medicinal products without valid registration certificates of the EAEU member states can only be registered in accordance with the rules approved by the EEC.
The drug market in the EAEU has common regulations, procedures, and requirements, but today there is no single registration authority for all the states that are members of the Union. To bring drugs to the EAEU markets, the manufacturer must either consistently carry out the examination and registration procedure separately for all five member countries or send the documents to the registration authority of one of the member states, and then apply for their recognition in other member states.
Additionally, the approvals procedure is different in each country. In some, the applicant company sometimes waits for years for a response. With mutual recognition, even if the registration report in one country is positive, they may not agree with it in another, if, for example, they already have a similar drug. Therefore, a new regulator is needed to ensure a centralized examination and registration of drugs.
The association proposed to the EEC to create a single regulatory supranational body in the EAEU is like the European Medicines Agency, which has a 30-year history of successful work.
In a pandemic, it is important to ensure the availability of complex biological and other drugs for the population of all five EAEU states, and it is important to involve the best experts from different countries in the registration procedure.
The emergence of a Eurasian regulator in the field of drug circulation can strengthen the position of local pharmaceutical companies in the international market, according to Stanislav Naumov, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union.
“The positive experience of Europe is that European manufacturers have not only managed to maintain their influence on the EU market and are also able to compete with the United States and Japan. These drugs are trusted all over the world. It is important for the EAEU to do the same. The Pharma-2030 program currently being developed should be export-oriented. That is, drugs registered on the territory of the EAEU should be in demand all over the world. This will allow us to strengthen our positions, in the markets of those countries with which the EAEU has concluded free trade agreements.” said Naumov.
The EAEU has a population of about 176 million people and a GDP (PPP) of about US$5 trillion, making it a significant market of interest to Chinese TCM and Indian pharmaceutical manufacturers should the regulatory aspect ease up and respective Free Trade Agreements finalized.
Russia Briefing is written by Dezan Shira & Associates. The firm has 28 offices throughout Eurasia, including China, Russia, India, and the ASEAN nations, assisting foreign investors into the Eurasian region. Please contact Maria Kotova at firstname.lastname@example.org for Russian investment advisory or assistance with market intelligence, legal, tax and compliance issues throughout Asia.