According to the current national regulations, all drugs that are introduced to the market should undergo a multi-stage procedure of state registration. Successful registration results in obtaining a Registration Certificate of the Ministry of Health of the Russian Federation (MH RF). How to launch new drugs to the Russian Market?
The whole process of drug registration can be broken down into five stages (see above).
Keep in mind that the registration scheme below is typical for generic drugs only, whereas for other types of drugs the second and third stage are usually repeated 2-3 times.
The thing is that a registration process is heavily dependent on the type of drug. This goes for the development of a registration dossier and for the scope of nonclinical and clinical studies.
For example, a clinical bioequivalence study is sufficient for generic drugs in any oral forms, if it is possible to measure blood / urine levels of their active substances. For other generic drugs, a clinical study of therapeutic equivalence is performed.
Original and biosimilar drugs are subject to more strict examination, requiring a series of 2 to 3 registration clinical trials of Phase I, II and III and a large set of nonclinical studies.
And such "details" are numerous. "Details" that directly affect your project's success: the timeliness of the drug's "launch", its payback period, the efficacy of marketing activities and, consequently, sales.
You may be familiar with a situation, when, contrary to your plans, the project deadlines are tragically missed, the costs unexpectedly double and the quality of the work itself leaves much to be desired. In other words, attempts to solve your tasks lead to new problems.
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