SubjectsSubjects(version: 949)
Course, academic year 2023/2024
Drug Regulation - M110009
Title: Regulace léčiv
Guaranteed by: Department of Organic Chemistry (110)
Faculty: Faculty of Chemical Technology
Actual: from 2023
Semester: winter
Points: winter s.:5
E-Credits: winter s.:5
Examination process: winter s.:
Hours per week, examination: winter s.:3/0, Ex [HT]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
Language: Czech
Teaching methods: full-time
Teaching methods: full-time
For type: Master's (post-Bachelor)
Note: course can be enrolled in outside the study plan
enabled for web enrollment
Interchangeability : M110021, N110031
Is interchangeable with: M110021
This subject contains the following additional online materials
Annotation -
Last update: Kundrát Ondřej Ing. Ph.D. (26.02.2018)
The essential aim of the subject is to give the basic information about the rules governing related areas such as development, manufacturing, wholesaling or advertising of medicinal products for human use as well as responsibilities of stakeholders and sources of relevant information. The mass-produced medicinal product is subject to registration prior to marketing in the Czech Republic. In the lectures, the students learn the basic information relating to documentation in which the future holder of the marketing authorization demonstrates safety, efficacy and quality of the product. Students will become familiar with the Act of Pharmaceuticals, Advertising Law, principles of pricing and reimbursement in the Czech Republic, and they will acquainted with the new FMD Directive relating to packaging
Aim of the course -
Last update: Fialová Jana (04.01.2018)

The students will be able to

able to choose the relevant regulatory activities regarding to the specific phase of the lifecycle of the medicinal product

get familiar with the sources of relevant information including databases and journals

get familier with the basic principles of pharmacoeconomy

get familier with the basic principles of pharmacogenomics

Literature -
Last update: Fialová Jana (04.01.2018)

R: actual lessons(\\\public)

R: Zákon o léčivech (č.378/2007 Sb.)

R: Zákon o péči o zdraví lidu (20/1966 Sb.) ve znění pozdějších předpisů - základní právní předpis zdravotnického práva v ČR

R: Zákon o veřejném zdravotním pojištění (48/1997 Sb.) ve znění pozdějších předpisů

A: Zákon o ochraně veřejného zdraví (č. 258/2000 Sb.) ve znění pozdějších předpisů

A: Historie farmacie v Českých zemích, Dagmar Broncová (ed.),MILPO Media, Praha 2003

A: Technologie léků, Pavel Komárek, Miloslava Rabišková et al.,Galén 2006

A: Adaptogeny, David Winston, Steven Maimes, Triton 2011

Learning resources -
Last update: Fialová Jana (04.01.2018)

European Commission :






Syllabus -
Last update: Fialová Jana (04.01.2018)

1.History of pharmacy

2.Public health system, regulation of prices and reimbursement in the Czech Republic

3.Harmonisation of regulatory activities regarding pharmaceuticals (ICH, WHO, EC, EMA)

4.Regulatory system of ppharmaceuticals in the Czech Republic, activities areas and responsibilities of the State Institute for Drug Control on the national and european level

5 Requirements on dossier for specific medicinal products (orphan drugs, biotechnological products, radiopharmaceuticals, herbal and homeopatic medicines), pediatric and geriatric use of pharmaceuticals

6.Position of original and generic pharmaceuticals, biowaivers, biosimilars

7.Basic principles of pharmacoeconomy

8.Quality insurance in the area of pharmaceuticals GXP (GMP, GLP, GCP, GRP)

9.Enforcement - illegal situations including manufacturing , import, distribution, supplying or sale of unauthorised product, basic information concerning the advertising of human medicinal products

10.Communication and crisis management, public information and restricted information - issues regarding pharmaceuticals

11.Pharmaceutical market - national and european view (segmentation, development)

12 Addictology, doping

13.Pharmacogenomics - basic principles

14The position of the pharmaceutical manufacturer and the regulatory authority, ethic views

Entry requirements -
Last update: Kundrát Ondřej Ing. Ph.D. (08.01.2018)

It is recommended to pass Fundamentals of Chemistry of Pharmaceuticals (B110009) and Fundamentals of Pharmacology (B111005) prior to the subject.

Registration requirements -
Last update: Kundrát Ondřej Ing. Ph.D. (08.01.2018)


Course completion requirements -
Last update: Kundrát Ondřej Ing. Ph.D. (26.02.2018)

The course ends with an exam consisting of an oral part.

Teaching methods
Activity Credits Hours
Konzultace s vyučujícími 1 28
Účast na přednáškách 1.5 42
Příprava na přednášky, semináře, laboratoře, exkurzi nebo praxi 1 28
Příprava na zkoušku a její absolvování 1.5 42
5 / 5 140 / 140