Tag Archives: Drugs

Which variations to the registration dossier for drugs do not require expertise in 2023?

In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for making some changes to the registration dossier for a medicinal product (MP). Thus, the changes have impact on grounds for making changes to the registration dossiers that do not require an examination of quality, efficacy and safety. Now examination of

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New side effect of valproic acid.

At the beginning of April 2023, a letter was published on the website of Roszdravnadzor for healthcare professionals about new data on the safety of drugs with an international non-proprietary name (INN) – valproic acid. This letter is based on a notice from Sanofi Russia regarding a higher risk of developing neurodevelopmental disorders (NDPD), including autism spectrum disorders, in children

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Termination of supplies of the drug “Ozempic” in the Russian Federation.

In November 2022, Roszdravnadzor received a notification from the Novo Nordisk manufacturing company about the planned termination of supplies of the Ozempic drug to the Russian Federation. It should be noted that according to the current legislation of the Russian Federation, the holder of the registration certificate must notify Roszdravnadzor in advance (1 year in advance) of the termination of

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Grace period in the registration of drugs.

Regulatory affairs specialists often come across the concept of grace period. For an ordinary consumer who buys a particular drug, this phrase usually does not have any meaning. However, not only but grace period determines the “speed” of updating instructions and packaging materials on the market. Let’s imagine the situation when the manufacturer has discovered a new contraindication to the

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Inventory shortage or risk of inventory shortage – update of legislation 2023.

In 2022, the Government of the Russian Federation developed a number of regulations regarding the circulation of medicines for medical use in the event of inventory shortage or risk of inventory shortage of medicinal products (Orders No. 593, PP No. 440, Order No. 339n). On February 13, 2023, Order No. 724n “On Amendments to the Regulations on the Interdepartmental Commission

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The first registration certificate for a medicinal product was obtained under an accelerated procedure.

In 2022, the so-called “accelerated” registration procedure for medicines for which there is a risk of inventory shortage was organized in Russia (read more about this phenomenon in previous articles). In December 2022, the first marketing authorization (MA) was obtained in the frame of this procedure. The Ministry of Health of Russia approved the antitumor drug Pembroria (international non-proprietary name

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4-aminophenol in drugs and not only: in what way it is dangerous?

According to the register of medicines in the Russian Federation, there are 218 drugs containing paracetamol as an active pharmaceutical ingredient. Paracetamol is widely used as an antipyretic and pain reliever among adults and children. The chemical-pharmaceutical synthesis of paracetamol is carried out from 4-aminophenol, the content of which is normalized in all drugs based on paracetamol. What for? 4-aminophenol

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New HIV drug approved in Europe.

On June 23, 2022, an innovative HIV drug called Sunlenca (lenacapavir) manufactured by the American company Gilead was approved in Europe. The drug has been approved under a centralized procedure in all 27 EU member states, including Norway, Iceland and Liechtenstein. The regulators made their decision based on a phase II/III study called CAPELLA. In the trial, 83 % of

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