The State Pharmacopoeia Development Department

Jalilov Habibulla Karimovich – Head of the State Pharmacopoeia Development Department, Chief Editor of the State Pharmacopoeia of the Republic of Uzbekistan, DSc, Professor.

The State Pharmacopoeia Development Department is a structural subdivision of the State Institution “Center for Pharmaceutical Products Safety”, which carries out activities for the development and publication (republication) of the State Pharmacopoeia of the Republic of Uzbekistan.

The Department in its activities follows the Constitution of the Republic of Uzbekistan, laws, decrees, resolutions and orders of the President of the Republic of Uzbekistan, resolutions of the Cabinet of Ministers, orders, orders and instructions of the Minister of Health, orders and instructions of the Center and recommendations of the World Health Organization.

The Department, within the framework of its activities, organizes, coordinates and controls the work of the Editorial Board, the Editorial Council and its Secretariat of the State Pharmacopoeia of the Republic of Uzbekistan, Specialized Expert Commissions and their working groups, which are an integral part of the development system of the State Pharmacopoeia, and also supervises the implementation of the tasks assigned to them.

The department consists of the head of the department, the chief specialist, the leading specialist and specialists of the 1st category.

Rights of the Department

The Department establishes cooperation with the International Pharmacopoeia of the World Health Organization, leading regional and national pharmacopoeias to harmonize the State Pharmacopoeia of the Republic of Uzbekistan with modern requirements and leading internationally recognized pharmacopoeias.

In the process of fulfilling the tasks assigned to it, the Department has the right to cooperate in the established manner with the organizational structures of the Center, scientific and control-analytical laboratories, testing centers, and also to involve independent experts in the development of pharmacopoeial monographs and examination processes.

Purpose, tasks and functions of the department

The main purpose of the department is:

Development and preparation for publication (republication) of the State Pharmacopoeia of the Republic of Uzbekistan taking into account modern international requirements for the quality and methods of control of pharmaceutical products.

The main tasks of the department are:

participation in the organization and implementation of state control over the quality of medicines and medical products; ensuring the safety of medicines for the population by introducing advanced foreign practices and international quality control standards into the pharmaceutical industry;

improving the standardization of the quality of medicines in circulation in the local pharmaceutical market;

harmonization of regulatory documents on medicines and medical devices with international standards, as well as with the standards of developed countries;

participation in increasing the potential and creating a reserve of personnel engaged in the standardization of medicines and medical devices;

State Pharmacopoeia, pharmacopoeial monographs of medicines and medical devices and the establishment of international cooperation to improve them.

The Department, in accordance with the tasks assigned to it, performs the following functions:

1) In the sphere of organizing and participating in the implementation of state control over the quality of medicines and medical devices:

develops, prepares for approval and publication the State Pharmacopoeia at least once every five years;

prepares annexes to the State Pharmacopoeia for approval and publication in the period between the reprints of the State Pharmacopoeia;

carries out the State Pharmacopoeia in both book and electronic forms;

preliminarily posts on the Center’s website for discussion between the legal entities and individuals involved, monographs newly introduced or excluded from the State Pharmacopoeia, as well as changes and additions made to the pharmacopoeial monographs contained in the State Pharmacopoeia;

adds monographs prepared in Uzbek and Russian languages to the section “Information on the State Pharmacopoeia” of the scientific and practical pharmaceutical journal “O’zbekiston Farmatsevtik Xabarnomasi”.

 

2) In the area of ensuring the safety of medicines for the population by introducing advanced foreign practices and international quality control standards into the pharmaceutical industry:

submits for development, publication (republication) and implementation into practice the State Pharmacopoeia, harmonized with modern requirements;

in the period between publications and republications of the State Pharmacopoeia, in order to harmonize the State Pharmacopoeia with leading international pharmacopoeias, taking into account local conditions, carry out work on introducing new pharmacopoeial monographs, amending current pharmacopoeial monographs, and issuing pharmacopoeial monographs that have lost their relevance;

implementation of modern progressive requirements for quality standards of medicines and medical devices, increasing their export potential and ensuring the safety of medicines for the population;

организация научно-исследовательских работ по совершенствованию стандартов продукции отечественной фармацевтической промышленности.

3) In the area of improving the standardization of the quality of medicines in circulation on the local pharmaceutical market:

develops proposals for the implementation of international requirements for the improvement and standardization of current regulatory documents for medicines based on the requirements of the Good Pharmacopoeial Practices (GPhP) of the World Health Organization;

participates in the development of regulatory documents for medicines and medical devices, and also submits its proposals for the improvement of the enterprise standard (SP) and other regulatory documents for medical devices;

gives its proposals for amendments, cancellation, termination, extension of validity and revision of Pharmacopoeial monographs (PhM), Temporary pharmacopoeial monographs (TPhM), An enterprise pharmacopoeial monograph (EPhM), General Monograps (GM), Industry standard (IS), specifications whose validity has expired;

develops and participates in the implementation of advanced uniform requirements for standardization and quality control of medicines in the pharmaceutical industry.

 

4) In the area of harmonization of regulatory documents on medicines and medical devices with international standards, as well as with the standards of developed countries:

develops and regularly improves the state pharmacopoeia in accordance with the requirements of the international, regional and local pharmacopoeia, updates it based on the achievements of modern science, high technology and effective alternative methods;

participates in bringing regulatory documents on medicines and medical devices in line with the requirements of international standards, as well as internationally recognized standards;

compiles and regularly updates the list of pharmacopoeial standard samples of active pharmaceutical ingredients and foreign substances used in the production and quality control of medicines and medical devices in the Republic of Uzbekistan;

If necessary, participates in the work on harmonization of regulatory documents on medicines and medical devices with international standards.

5) In the area of participation in increasing the potential and creating a reserve of personnel engaged in the standardization of medicines and medical devices:

organizes scientific and practical seminars and conferences in order to accelerate work on the implementation of the State Pharmacopoeia into practice;

provides organizational and methodological assistance to higher educational institutions, research institutes in areas related to the quality, circulation of medicines, medical devices and medical equipment;

establishes cooperation with world pharmacopoeias and pharmacopoeial bodies in order to increase human resources, exchanges experience, improves qualifications, participates in scientific events, classes, seminars.

6) In the field of the State Pharmacopoeia, pharmacopoeial monographs of medicines and medical devices and the establishment of international cooperation for their improvement:

establishes cooperation with world pharmacopoeias and pharmacopoeial bodies on the State Pharmacopoeia, pharmacopoeial monographs of medicines and medical devices and their improvement;

participates in scientific conferences and research work on the improvement of pharmaceutical product standards, introduces international experience and scientific achievements into the field.

7) In other areas of activity:

develops a generalized dictionary, an explanatory dictionary for users of the State Pharmacopoeia, as well as electronic dictionaries of medicinal plants used in medical practice of the Republic of Uzbekistan;

prepares scientific articles, regulatory, legal and other documents and information on standardization in the field of pharmaceuticals for publication in official sources.

The department carries out its relations in all areas of activity in accordance with the goals and objectives on the basis of contracts concluded with legal entities and individuals in the manner prescribed by law.

The department may also carry out other types of activities not prohibited by law.

The coordination of the activities of the Department is carried out by the Center.