Below is a selection of top stories in Russian pharma from recent months, ranging from proposed changes in legislation, labelling system updates, priorities set forth by the country’s manufacturing association and new breakthroughs in Coronavirus diagnostics.
Government amends legislation around emergency response to diseases
The State Duma, as is called the lower house of the Federal Assembly of Russia, passed an amendment regarding urgent response to disease spread, giving the government additional powers and rights to declare high-alert situations and establish rules of conduct as well as regulate the trade and registration of medicinal products. This special amendment was introduced in response to the ongoing coronavirus and includes regulation of procurements from suppliers.
Labelling legislation could be put on “quarantine” for now
One of the key developments in Russian pharma last year was the introduction of new regulations on drug labelling that have been set to take effect July 1. The new mandatory labelling system has already been postponed from its original January 1 start date due to issues with coding. Medicines that are produced before the July 1 effective date may be sold and transported without the mandatory labels. However, the Association of Russian Pharmaceutical Manufacturers (ARPM) has issued a request asking to extend the date further due to difficulties encountered while preparing for the system’s launch. Furthermore, the ban on travel due to the coronavirus quarantine prevents specialists from traveling to Russia to perform essential testing.
http://www.en.arfp.ru/press-tsentr/will-coronavirus-send-labeling-to-quarantine/
Drug manufacturing leadership highlights priorities for the year
The Association of Russian Pharmaceutical Manufacturers (ARPM), founded in 2002, brings together leading Russian pharmaceutical companies. ARPM Director General Victor Dmitriev set forth his visions for the upcoming year at the recent pharmaceutical marketing conference RAPM. His top priorities include changes to public procurement, solving ongoing issues with drug labelling, implementing drug reimbursement models, introducing a so-called “regulatory guillotine,” reducing drug surveillance to a single oversight body, tackling the issue of unregistered drug imports, interchangeability, compulsory licensing to protect intellectual property, defining rules around online drug sales, and improving certification procedures at the Eurasian Economic Union level.
http://www.en.arfp.ru/press-tsentr/arpm-10-directions-of-pharmaceutical-industry-development/
Russian scientists develop high-precision test for Coronavirus diagnosis
At the Central Research Institute of Epidemiology of Rospotrebnadzor, scientists recently formulated a new set of reagents for the detection of Covid-19. The new diagnostic kit passed clinical trials and was registered for use in Russia on 25 March, meeting requirements for sensitivity and specificity.
Legal Roundup
Pharmvestnik prepared an overview of industry regulations currently being considered for approval. Some of the regulations include setting maximum retail prices on medical products, emergency response, increasing criminal liability for violating sanitary rules, contracts for purchasing disinfectant supplies, labeling codes for drug circulation, registration of medical devices, and procurement.
https://pharmvestnik.ru/content/news/Obzor-otraslevyh-normativno-pravovyh-aktov-78.html
