At this year’s Saint Petersburg International Economic Forum, special consideration is given to the topics of pharmaceuticals, medicine, and healthcare. As one of the key objectives set by Pharma 2030 concerns product export in this field, stakeholders from regulatory authorities, industry associations and the largest exporters held a session meant to identify the forward-looking growth points.
The main tasks of the Strategy for development of the pharmaceutical industry of the Russian Federation for the period up to 2030 (Pharma 2030) include increasing exports of pharmaceutical products. According to forecasts by the Russian Ministry of Industry and Trade, by 2030, exports of Russia-made pharma products could demonstrate a five-fold growth if state support measures are implemented. At the same time, export is not just product supplies to another country. It is particularly challenging to introduce a drug product to highly competitive markets. In fact, the offer by Russian companies should be a unique one: a novel drug product effective in fighting against new diseases or those having no market solution for their treatment. Currently, such drugs are biomedical cell products. But the process of such product development and market launching is not quite simple and fast. Besides, such projects are capital-intensive with high risks. Another promising area of activity includes Russian vaccines, insulins and other drugs for treatment of socially significant diseases. The demand for them is particularly high in Latin American countries. Needless to say, all markets demonstrate an increased demand for drugs in such landscapes as palliative, pediatrics, orphan diseases. In this regard, attendees of the session “Export Potential of Russian Pharmaceuticals: In Search of Growth Points” have suggested thinking about establishment of the national export strategy.
And what do regulators have to offer and what are they doing today to support the domestic pharmaceutical industry in terms of export?
First of all, Minpromtorg of Russia together with SID & GP are working towards mutual recognition of the results of GMP-inspections with regulators in different regions and establishment of bilateral agreements. As reported by SID & GP authorized to carry out inspections of foreign drug manufacturers for GMP compliance, as of today, Memoranda on Cooperation have been signed with the following regulatory agencies:
- Agency for Pharmaceutical Industry Development under the Ministry of Health of the Republic of Uzbekistan (ARFO)
- CECMED (State Center for the Control of Medicines, Equipment and Medical Devices of the Cuba’s National Regulatory Authority)
- ISP CHILE (Public Healthcare Institute of the Republic of Chile)
- AEMPS (Spanish Agency of Medicines and Medical Products)
- MHRA (United Kingdom)
- Bulgaria (Bulgarian Drug Agency of the Ministry of Health of the Republic of Bulgaria)
- National Center for Expert Evaluation of Drugs, Medical Devices and Medical Equipment (Kazakhstan)
- Scientific Center for Expert Evaluation of Medicines and Medical Technologies named after Academician E. Gabrielyan (Armenia)
- Republican Unitary Enterprise – Center for Expert Evaluation and Testing in Healthcare (Belarus)
- Food and Drug Organization of the Ministry of Health and Medical Education of the Islamic Republic of Iran (Iran)
- H.I.CO (Cluster of Health Innovation and Community) (Italy).
Minpromtorg of Russia together with SID & GP are moving towards having mutual recognition with PMDA (Japanese Pharmaceuticals and Medical Devices Agency), while working on PIC/S accession. As emphasized by the Director of SID & GP, Mr. Vladislav Shestakov, a two-year period for Russia to finalize its pre-accession process is about to expire in August:
We are now closely cooperating with PIC/S auditors in collecting all documents needed for PIC/S pre-accession assessment. After the auditors have elaborated their report, we expect to obtain the pre-applicant’s status by the end of the year. At the same time, I cannot stress it enough, PIC/S membership does not automatically guarantee mutual recognition of the results of GMP inspections, as, in this structure, recognition of certificates among member states is regulated exclusively by bilateral agreements, but not by common guidelines of the organization. Although, it is obvious that Russian GMP inspectorate’s joining the Pharmaceutical Inspection Co-operation Scheme will exponentially increase confidence of foreign regulators in the products and the results of Russian tests submitted by our pharmaceutical companies when applying for export of medicines.