How are drugs approved in Russia?
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How are drugs approved in Russia?
Authorisation. To be distributed in the Russian Federation, a drug must go through clinical trials and receive approval from the Ministry of Health. This authorisation requires a completed registration procedure involving: Submission of a registration dossier.
What is the equivalent of the FDA in Russia?
Ministry of Health of the Russian Federation – The Russian Government.
What is drug registration?
It has been defined as: “a system that subjects all pharmaceutical products (under the scope of the NRA) to pre-marketing evaluation, marketing authorization (registration), and post-marketing review to ensure that they conform to required standards of quality, safety and efficacy established by NRA” (4).
Is Pfizer still operating in Russia?
From a production perspective, Pfizer does not own or operate any manufacturing sites in Russia.
What are registration requirements for a new drug?
What documents are required for pharmaceutical registration?
- Drug name.
- Dosage form.
- Composition of formulation.
- Test specifications for Active ingredients & Inactive ingredients.
- Pharmacological classification.
- Indications.
- Manufacturer(s) of raw materials.
- Applicable patents, if any.
Why is registration required for new drug products?
All new drug products must be registered and approved by the regulatory agency governing the intended market before the products can be introduced into the market. The registration process is to ensure the quality, safety, and efficacy of drug products.
When did CFDA change to NMPA?
On 1 September 2018, the CFDA (China Federal Drug Administration) was replaced by the NMPA (National Medical Products Association).
What does the NMPA do?
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices.
Is J&J still doing business in Russia?
Decathlon and Johnson & Johnson on Tuesday became the latest major Western brands to suspend operations in Russia as the economic fallout from Moscow’s invasion of Ukraine continues to mount.
