Author Archives: beawire

Reference, generic and biosimilar drugs

As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of drugs as reference (= Brand name), generic and biosimilar drugs. According to statistics, more than 60% of drugs on the Russian market are generics, or reproduced drugs. Definitions According to the Federal Law 61 reference drug is called a

Read more

Import of samples for declaration of perfumery and cosmetic products

Declaration of perfumery and cosmetic products on the territory of the customs union becomes a difficult task for foreign manufacturers. In particular, it is a question of import of samples to the territory of the Russian Federation. Just a few months ago, it was possible to use any samples on the hands for declaration purposes. However, everything has changed since

Read more

Silicons in cosmetics, drugs and medical devices

Nowadays, we can often hear that certain cosmetic products do not contain parabens and silicones. About what parabens are, what they are used for and how dangerous they are, you can read here. As for silicones, they are widely used in pharmaceutical, cosmetic and food industries, as well as in medical practice. Since 2002, approximately 470,000 tons of silicones have

Read more

Parabens in cosmetics and drugs

Parabens are widely used in the cosmetic, pharmaceutical and food industries as preservatives. Their use is not prohibited by the FDA of the USA and the Russian Federation, but in EU countries their content, for example, in cosmetic products has a maximum permissible concentration (MPC) — 0.4% for individual substances and 0.8% for mixtures of substances.  What are parabens? Is

Read more

Approvals for drugs

Our new topic about drugs regulation: what are drugs and how to determine it from borderline products? how to receive state registration and permission for clinical trials? what actions are required for pharmaceutical substance? Find answers in our new big topic – by link.

Read more

The Federal Service for Surveillance in Healthcare stopped the implementation of unregistered medical devices, as well as the carrying out of illegal plastic surgeries, at the specialized exhibition of the beauty industry “INTERCHARM Professional” in Moscow

On 19 April 2019 the territorial body of the Federal Service for Supervision in Healthcare in Moscow and the Moscow region, together with law enforcement agencies, conducted control and supervisory measures at a specialized exhibition for professionals of the beauty industry and salon business “INTERCHARM Professional”, which was held on the territory of the Crocus Expo exhibition complex in Moscow.

Read more

As a result of joint actions by the Federal Service for Supervision in Healthcare and law enforcement agencies in the Orenburg region, illegal activities to manufacture and market an unregistered medical device were stopped.

As a result of control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare in the Orenburg region exposed the production of an unregistered medical device Emplastrum “Silver Bridges” in the city of Gai. Information on the illegal production was sent to the Ministry of Internal Affairs of Russia in the Orenburg region to make a

Read more

Provision of licensing of BMCP production

Following the last session on biomedical cell products (BMCP) within IPhEB 2019 (read more in the article), there was published the Order on the administrative regulations for the provision of licensing services for the production of BMCP on the website of Roszdravnadzor. Licensing of production has long been a pressing problem in the organization of introduction of BMCP into circulation.

Read more

BMCP — problems and prospects of development in Russia

In April 2019, within the framework of the IPhEB Russia exhibition, held in St. Petersburg, a thematic session “Development of biotechnological direction in the pharmaceutical industry” was held. The session was devoted to various aspects of the life cycle of biomedical cell products (BMCP) and prospects of such products entering the Russian market. Currently, in Russia there is no registered

Read more
« Older Entries