PETCTP STATE pharmaceuticals (The state register of the pharmaceuticals allowed for use in medical practice and for industrial production) — official dynamic system of legal and scientific and technical documentation on the pharmaceuticals allowed in the USSR for medical use and industrial production.
The river of has absolute importance in the state system of registration, production and control of pharmaceuticals in the USSR, the foundation a cut was laid by the decree of Council of People's Commissars about the organization of the National commissariat of health care of RSFSR (1918). All questions connected with providing the population with the medicinal help were carried by this decree to competence of the National commissariat of health care. The organizational principles of registration and control of pharmaceuticals in the USSR gained further development in a number of the subsequent resolutions of Council of People's Commissars. In this respect the resolution of Council of People's Commissars of the USSR adopted in 1937 «About production and production of new pharmaceuticals» was important, the Crimea was established that permission to production and use of pharmaceuticals is carried out by the National commissariat of health care of the USSR after data acquisition about their experimental studying and clinical Tests (see. Control of pharmaceuticals ). It was specified in the same resolution that the new drugs allowed for production and use in the USSR shall be entered in the special register pharmaceuticals (see).
During the different periods of development of the Soviet state approaches to the organization and R.'s maintaining of changed depending on the tasks facing health care. Cardinal review of a question of the nature of registration and an order of maintaining R. of was made after creation as a part of M3 of the USSR of Management on implementation of new pharmaceuticals and medical equipment (1969), R.'s maintaining of was referred to competence to-rogo along with other tasks. It gave the chance from new positions to carry out work on R.'s improvement of according to modern requirements. Since 1971 it is made out as dynamic system of documentation containing the complete information about medicine (the registration certificate, temporary pharmacopoeian article, the application instruction, a leaf insert, the order for industrial production and other documents). All new drugs join in the state register in week time after the publication of each next order of the Minister of Health of the USSR allowing their use.
The state register consists of four sections.
First section The river of represents the list of the official names of the pharmaceuticals allowed for use located in alphabetical order with their registration numbers.
Second section The river of contains passports of drugs, to-rye include the data characterizing medicine from the point of view of its chemical structure and pharmakol. properties, and also official documents on permission of clinical tests, their end, the recommendation of drug to medical use. Passports of drugs are made out by Pharmacological committee M3 of the USSR in the period of the solution of a question of clinical testing of each medicinal substance. After completion of clinical tests the specified material goes Pharmacological committee (see) in Management on implementation of new pharmaceuticals and USSR M3 medical equipment and further it is conducted by Management.
Third section The river of includes the following official documents: application instructions, pharmacopoeian articles, calculations of the recommended volumes of productions for the first two years, requests for drug for the organization of industrial release, registration certificates on drugs and orders of the Minister of Health of the USSR on permission of the corresponding pharmaceuticals for medical use. This section contains also special inserts, in to-rye the changes or additions arising in the course of industrial production and use of drug in medical practice are as required made. Thus, the third section P. of which is regularly supplemented by Management on implementation of new pharmaceuticals and USSR M3 medical equipment is the collection of the official documents characterizing properties and an order of use of drugs, methods of their control and the course of registration for transfer for the purpose of industrial production.
Fourth section The river of contains materials about an exception of the nomenclature of outdated pharmaceuticals.
Regularly (1 time in 2 years) the Management on implementation of new pharmaceuticals and USSR M3 medical equipment, on the basis of the first section P. of, publishes the list of pharmaceuticals with their registration numbers for operational use by all institutions of the USSR which are engaged in research, implementation, production, and also applying pharmaceuticals. This list is issued under the name «The State Register of the Pharmaceuticals Allowed for Use in Medical Practice and for Industrial Production», with the instruction that actually it represents the first section P. of as of the corresponding day of the edition.
R. join not only medicinal substances and dosage forms from them, but also aids, medicinal plants, medicinal vegetable raw materials, nek-ry reactants and standard samples of pharmaceuticals.
As of January 1, 1982 R. included 2488 medicinal substances and means, 268 medicinal plants and medicinal vegetable raw materials, 48 radio pharmaceuticals, 59 aids and reactants and 85 standard samples of medicinal substances.
Regularly according to the recommendation of Pharmacological committee orders of the Minister of Health of the USSR from the nomenclature exclude outdated pharmaceuticals in this connection corresponding changes are made to R. Since 1982 the first part P. of is made out by the principle of allocation of the corresponding groups of medicinal substances, drugs from them, aids, medicinal plants, etc.
Such execution of the list of pharmaceuticals in the state register gives the chance more quickly to them to use.
The river of is the official document and shall be used by institutions and specialists by preparation of reference books, instructions, methodical instructions and other materials in the pharmaceuticals allowed for use in the USSR or earlier resolved, but drugs excluded from the nomenclature.
A holder of a reference copy of R. of is Management on implementation of new pharmaceuticals and USSR M3 medical equipment, Krom was granted the right of maintaining R. of and entering into it of necessary changes.
Abroad there are no pharmaceuticals of the USSR of systems of legal and scientific and technical documentation similar to the State register. In the majority of the countries the state registers are made out in the form of the official document, in Krom only names of new pharmaceuticals in process of their permission to a medical use are registered.
See also Pharmacopoeia .
E. A. Babayan.