From Internet resource medlinks.ru published information about the new draft amendments to the Law "On Circulation of Medicines", which defines the procedure for conducting clinical trials of new drugs.This project, which sets additional administrative check the progress of such tests, prepared by the Ministry zdravsotsrazvitiya Russia and RZN.As according to officials, it is intended to make the testing of new drugs safer for Russian patients.However, experts of the pharmaceutical market have expressed concern that the draft contains a large number of redundant bureaucratic barriers.
Now, according to these proposals, conducting clinical trials in medical offices is proposed to adjust the two new documents, the first of which themselves are the amendments to the law "On Circulation of Medicines", and the second is the administrative regulations Roszdravnadzor control tests.Some of the proposed changes would substantially simplify the treatment of Russian citizens.For example, we plan to make the law ru
For example, in the Russian Children's Clinical Hospital relatively recently had to treat one of the patients registered in the Russian drug.According to the Head of the Department of General Hematology Hospital Mikhail Maschan, in this case, it took personal order of Russian President Vladimir Putin.
Roszdravnadzor has the following statistical information: the market of clinical trials in Russia reached $ 150 million, the study carried out in 80 regions of the Russian Federation, covering 799 health uchrezhdeniy.Tolko 2006 Russia took part in 324 clinical trials, the total number involved in these studiesman about 50 thousand. Russians).
Besides all of the above, draft legislation is now canceled and accreditation for health institutions that engage in the activity of clinical trials.Now, to begin testing a new drug, any medical center will be required to obtain a permit for the study itself.This fact eliminates the occurrence of such a situation in which would have been possible lawsuits against researchers in the regions.To illustrate this innovation can remind one of the high-profile litigation with doctors Volgograd clinic, clinical trials in the field of pediatrics.The trial was made possible precisely for the reason that the clinic subordinated RZD, whereas under the current legislation departmental hospitals do not have such a right.
As explained officials, other provisions of the projects introduced additional degree of protection for the participating in the testing of new drugs patients.For example, Roszdravnadzor planned interim audit of the results of clinical trials, with permission to continue studies may be withdrawn in the event of negative results.It is also proposed specifically identify the stages of clinical studies to facilitate the intermediate control.The project also contains provisions imposing judicial responsibility for the conduct of clinical trials and treatment drugs, as at the moment "there are cases when the court can not accept the consumer appeal of the drug from the lack of proper defendant or the plaintiff," explained the adviser to the head Roszdravnadzor Mikhail Getman.
authors contributed to the projects and such amendments are justified by the need to equalize the working conditions in the Russian domestic and foreign pharmaceutical companies.Resolution plans to conduct clinical trials to issue only if the investigational drug in the future will be registered in Russia as a "Russian medicine should benefit from the fact that the studies carried out on Russian citizens," - explains the head of this moment Roszdravnadzor Nikolai Yurhel.In addition, the western pharmaceutical company will transfer all rights to the new medication to his Russian partner, ie,registration of drugs should be carried out in the name of a Russian legal entity.