Export issues – one of the major topics of the IV GMP-conference
On September 23, in terms of the IV All-Russian GMP-conference with international participation, Russian and foreign regulators and key exporters of pharmaceutical products will exchange their experience in the field of pharmaceutical products export abroad.
A world trend – supporting the local manufacturer not only inside the country, but also trying to expand commercial markets abroad.
It should be noted that the introduction of GMP standards and rules, which guarantee the medicines quality and safety, allows Russian manufacturers to be more competitive in domestic and foreign markets.
The strategic document for the pharmaceutical industry development in Russia – “Pharma-2030” will also account for the export development of the Russian pharmaceutical products.
In particular, active work is carried out to expand the range of opportunities in order to assist Russian companies manufacturing medicines and medical devices in terms of their export potential development as noted by Elena Denisova, the Deputy Director of the Department for the Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation.
The legislation of the Russian Federation provides some provisions allowing Russian medicines manufacturers to obtain from the Ministry of Industry and Trade of the Russian Federation documents required for export development:
- Manufacturing authorization of medicinal products for medical use (required for manufacturers not only to carry out manufacturing in Russia, but also when supplying medicinal products to other countries in the world);
- The manufacturer of medicinal products for medical use statement of compliance with the GMP requirements (our GMP certificate is accepted by the Union’s member states);
- A document confirming that the manufacturing of a medicinal product for medical use has been carried out in accordance with the GMP requirements and is subject to submission upon request of the authorized body of the country where the medicinal product is imported (CPP for the medicinal product for exporting to CIS countries and others);
- A document that confirms that the manufacturing of a pharmaceutical substance (PS) has been carried out in accordance with the GMP requirements and is subject to submission upon request of the authorized body of the country where the pharmaceutical substance is imported (PS document for exporting to CIS countries and others).
At the same time, the Ministry of Industry and Trade of the Russian Federation together with the Trade Representative Office of the Russian Federation cooperate with foreign regulators to inform Russian companies about regulatory aspects and the export-import structure of foreign markets, in addition to that provide various kinds of support in solving technical issues of interactions between Russian representatives and foreign experts, including questions related to the Russian medicines marketing authorization abroad.
It is important to mention the fruitful cooperation between the Ministry of Industry and Trade of the Russian Federation and the Russian Export Center on the organizational and financial support of the Russian enterprises with participation in international exhibitions to promote Russian goods.
In Svetlogorsk city at the IV All-Russian GMP-conference, authorities’ representatives will talk about the current as of today and offered to exporters tools of support from the Ministry of Industry and Trade of the Russian Federation.
Among the promising areas for local medicines on a global scale today, there is a high demand for Russian vaccines, insulin and other drugs for the treatment of socially significant diseases. All over the markets, there is a high demand for medicines dedicated to such areas as palliative care, pediatrics and orphan diseases. Biomedical cellular products are of a high interest. Identification of promising export markets for Russian companies, working conditions, experience of FDA and EMEA, and many other topics associated with export will be discussed by the Ministry of Industry and Trade of the Russian Federation, PMDA (Agency for Medicinal Products and Medical Devices of Japan), HALMED (Agency for Medicinal Products and Medical Devices of Croatia), flagships of the national pharmaceutical industry development – the most successful pharmaceutical clusters – at the panel discussion “Export and priority regions. Regulatory and industry tools”.
Dates and venue of the event: September 23, 12:30pm-2:00pm, Svetlogorsk city (Kaliningrad region), «Yantar-hall» (Lenin str., 11)
Registration is open on the official website of the IV All-Russian GMP-conference with international participation.
The organizers of the event are the Ministry of Industry and Trade of the Russian Federation together with the State Institute of Drugs and Good Practices (SID & GP).
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed