The 45th Anniversary of Institute for State Control of Drugs and ...

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Acta - Congressus Historiae Pharmaciae 2001 • ICMCF (Institute for Medicine Control and Pharmaceutical Researches), within the Health Ministry, with duties of research in the domain of methodology control and of checking the medicines used in therapies, and also of supporting the pharmaceutical network.. By the Order of Health Ministry no. 390 from April 1956, the Institute of Medicine Control and Pharmaceutical Researches, the Chemiotherapy Section Of Dr. Cantacuzino Institute, The Center of Medicinal Herbs and the Laboratory of Medicine Control are unified, thus resulting a single unit named “ Institute of Pharmaceutical Researches and Medicine Control”. By the order the order of Health Ministry from September 30 th , 1960, its name is changed into the institute for State Control of Medicine and Pharmaceutical Researches (ICSMCF). Based upon this order, the Institute was given the duties of the Pharmacopoeia Committee, Medicine Committee and the Scientific Council ruled by the director of ICSMCF was founded. In 1961, the leadership of Health and Social Regulations Ministry has decided that the editing of the 8 th release of the Romanian Pharmacopoeia and of its Supplements is the duty of the Institute. Text gathering and final editing of monographies were done by a commission of specialists lead by prof. Dr. Petre Ionescu-Stoian. The Romanian Pharmacopoeia (8 th release) was born in 1965 and it was followed by three supplements. The rapid progress of the pharmaceutical sciences imposed the release of the 9 th edition of the Romanian Pharmacopoeia, that was born on the 1 st of January 1977, with two supplements in 1981 and 1984. The need of a new edition of the Pharmacopoeia was imposed by the global and national progress in the field of medicines, some modifications to the existent monographies and creation of some others for the new products being necessary. The release in 1993 of the 10 th edition of the Romanian Pharmacopea meant an increase in exigency regarding Romanian medicine quality control and the conformity with the last editions of the international Pharmacopoeia. Since January, the 13 th 1996, Romania represented by ICSMCF has an observer statue for the European Pharmacopoeia.
Olimpia Sanda, Maria Gabriela man, Iulia NitescuSuli Fonded in 1949, the Medical Scientific Committee of Health Ministry had the duty of leading and coordinating the medical scientific activities at the national level. This one functioned through committees, problem institutes among which is the Medicine Committee, with the responsibility of approving new medicines, made in the country or imported. By the order of Health Ministry no. 1040 from 30 th of September 1960 the institute undertook the duties of Medicine Committee. According to Law no 3 from 1978 that stipulates that authorization and recording of new medicines is done by the Health Ministry with the agreement of the Medicine Committee on the basis of a scientific research methodology of the proposals of new medicines. By Order no. 387 from 15 th of September 1979, ICSMCF received the duty of ensuring the Secretary of Medicine Committee. Since 1973, the Institute had played the role of coordinating the pharmacovigilence network, founded in our country in that year, activity exercised through the Medicine Committee. Thus, it collaborates with OMS regarding the adverse reactions of medicines. Since 1963, the Institute has worked in a new center, built on the criteria of functionality characteristic to its profile and duties; in 1979, in the vicinity of this center, a modern construction was built, destined to the laboratory of research and biologic control. The regulation of organizing and functioning of ICSMCF was approved by the order of Health Ministry no. 323 from March, 21 st , 1963. Among the attributions of the institute comprised in this regulation, are: • Complex control of the medicines made in the country and of the imported ones. • Editing Pharmacopoeia and its supplements, on the basis of laboratory researches • Preparing the substances and reference patterns. • Validation of quality norms for the indigene products. • Establishing the methodology for medicine quality control by physico-chemical, pharmacological, microbiological and phytobiological studies • Yearly release of a medicine nomenclature • Observation of the global movements appeared in medicine production
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