REMEDIUM

The article deals with the institutional mechanisms for strengthening the research capacities in the development of innovative drugs, involving the improvement of the following institutions: state procurement, marketing authorization of drugs, government support for small and medium-sized businesses, state scientific and technical policy, science and education, international relations.

Болезнь Паркинсона - тяжелое нейродегенеративное заболевание, поражающее возрастную категорию населения и характеризующееся высокой степенью инвалидизации. Какими инструментами для ранней диагностики и сохранения качества жизни пациентов обладает современная медицинская наука? Об этом мы беседуем с заместителем директора по научной работе, руководителем отдела исследований мозга Научного центра неврологии РАМН, доктором медицинских наук, профессором, членом-корреспондентом РАН Сергеем Николаевичем Иллариошкиным.

A marketing study of suppositories included in the State Register of Medicinal Products of the Russian Federation was conducted. The study showed that suppositories accounted for 1.5% of the total amount of medicinal products in the State Register. The share of rectal suppositories is 61.9%, and a share of vaginal ones is 38.1%. Domestic-to-foreign products analysis showed that the domestic suppositories accounted for 68.6%, and the foreign ones accounted for 31.4%. 21 countries supply the suppositories to Russia. Germany (7.3%), Moldova (3.7%), Slovenia (2.8%) made up the largest share in the supplies. The pharmacological action analysis of suppositories allowed to establish that the largest number of suppositories manufactured in our country contain medicinal substances of non-steroidal anti-inflammatory (13.0%), antimicrobial and antiprotozoal (8%), antihemorrhoidal (7.7%), antifungal (7.9%), analgesic non-narcotic action (5.0%). The number of antiviral suppositories is insignificant and accounts for 1.3%. Content analysis made it possible to form an information array of suppository assortments of domestic and foreign manufacture to determine a rectal-to-vaginal suppository ratio.

The article presents the material on the progress in the promotion of the international standard Good Clinical Practice (GCP) in the Russian Federation and other post-Soviet states. Particular attention is paid to the contribution of the European Forum for Good Clinical Practice (EFGCP) to the process of implementation of GCP in the region. Examples of long-term cooperation of authorized facilities and the regional authorities with the EFGCP are given. The article shows the unique role of the European Forum for Good Clinical Practice in performing an independent, multidisciplinary and multinational analysis of the effectiveness of various GCP components with the consistent implementation of all approaches and rules in the course of scientific and technical improvement in conducting clinical trials. There are examples of mutually beneficial sharing of information and experience in improving the international clinical trial practice with the participation of the post-Soviet countries.

Financial status of pharmaceutical companies is analysed on the basis of state statistical reporting form No. P-3 Information on Company Financial Status (monthly).

The rating was conducted using the state reported financials form No. 2 data of over 60 largest pharma industry enterprises.

В ежемесячном обзоре проведен анализ судебной практики в сфере производства и обращения медицинской продукции, чтобы помочь специалистам отрасли избежать ошибок при решении сходных проблем.