Pharmacological Center

With the adoption in January 2003 the Law "On Medicines" was created the legal framework for building a system of state registration of drugs. Credit: Mark Hyman, MD-2011. Now set the order of preclinical and clinical research, monitoring of side effects drugs, controlled information about drugs. Improved rules for registration of drugs: uniform requirements for the formation of a registration dossier, approved the classification change, made to the registration dossier during the registration certificate (type I change does not require new registration, and type II, requiring a new registration of medicines), introduced a provision on the responsibility of the applicant provide to the Committee of Pharmacy report on the safety, efficacy and quality drugs at regular intervals and the responsibility of the applicant for compliance with drugs, supplied at the time of the registration identity, the samples submitted for state registration. Official site: CEO Mylan. Defined grounds for refusal of registration, reregistration, the order of suspension of registration certificates in case of earlier unknown hazards or side effects drugs. Set rules for expert work – no more than 6 months with the mechanism of "stopping the clock." As part of the Ministry of Health of RK as of 11/11/03, the 0-56 Improvement health services management of the population "was conducted re-analysis of normative and technical documentation in 2780 drugs registered prior to the 2003 study found that 242 of the drug, ie, 8.3% have low efficiency and an increased risk of harm to the patient's health, including 36 – in solid lekformah containing membranes composed of dyes that are prohibited for use in the EU, and (or) with no color indication of dye and (or) without specifying the composition of the shell, 18 – in the capsules, without specifying the composition of capsules, 30 HP, without specifying the composition of excipients, drugs in 79 solid lekformah: tablets, capsules, pills, with the index "dilution" below 75%, assuming no reservations about their prolonged action. These results suggested the need to improve the expert work.

In the next period was performed to optimize and standardization. Currently, examination is carried out in three stages: initial examination of the registration dossier, expert analysis of samples of drugs, specialized expertise in the pharmacopoeia and Pharmacological Center safety and efficacy. When RGP "NTSELS" was organized by the Expert Council, composed of leading professionals involved in primary, analytical, specialized expertise, and managers RSE "NTSELS." The main task of the Expert Council is to review the results of expert evaluation of drugs with an increased risk of: innovative medicines, new generics, as well as all cases of negative conclusions about quality, safety, efficacy and drug disputes expert opinions. Source: Journal 'Remedium'.