Veidlapa Nr. M-3 (8)
Study Course Description
Registration of Medicinal Products
Course Code
LFK_044
Branch of Science
Basic medicine; Social Pharmacy
ECTS
3.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time
Study Course Implementer
Course Supervisor
Milana Špoģe
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts
Riga, Konsula street 21, zftk@rsu.lv, +371 67061547
About Study Course
Objective
1. To provide an overview of the role of marketing authorisation to ensure safety, efficacy ad quality as part of the the pharmaceutical regulation, within a life cycle perspective.
2. To promote the acquisition of practical skills for the preparation of documentation for the marketing authorisation application of medicinal products.
Preliminary Knowledge
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, physical pharmacy, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, pharmacology. Knowledge of human anatomy, normal physiology, English, public health, pharmaceutical legislation, ethics and bioethics, toxicology, clinical epidemiology, good clinical practices, good laboratory practices, good manufacturing practices, quality assurance, pharmacovigilance.
Learning Outcomes
Knowledge
1.After successful completion of the requirements of the study course, students will have acquired knowledge that will allow: 1. Understand the importance of the marketing authorisation to ensure safety, efficacy and quality. 2. Understand the essence and meaning of the marketing authorisation process as part of the regulation of pharmaceuticals.
Skills
1.As a result of completing the study course, students: 1. Will be able to apply knowledge about the preparation of the marketing authorisation documentation of medicinal products with the requirements of the European Medicines Agency; 2. Will be able to analise the implication of the marketing authorisation in the life cycle of medicinal products from the development, use in the health systems and by individual patients and pharmacovigilance; 3. Will be able to correctly present the results of their practical work.
Competences
1.As a result of completing the study course, students will be able to to apply the rules and regulations for the marketing authorisation of medicinal products in the preparation of registration documentation and assess the importance of marketing authorisation in ensuring safety efficacy and quality for different stakeholders.
Assessment
Individual work
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Title
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% from total grade
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Grade
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|---|---|---|
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1.
Individual work |
-
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-
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Individual work – solving situations according to the topics of the study course.
In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal.
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Examination
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Title
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% from total grade
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Grade
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|---|---|---|
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1.
Examination |
-
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-
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Solving situation tasks, preparing presentations during practical classes, the average rating of which is the final grade of the course.
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Study Course Theme Plan
FULL-TIME
Part 1
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Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Drug registration procedure as part of drug regulation.
Aim of the lecture: to provide an overview of the context and concepts of regulation and drug registration as part of the regulation of human pharmaceutical/medicinal products with a life cycle perspective.
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-
Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Principles and objectives of marketing authorisation;
Objective: review key components of the marketing authorisation to ensure safety, efficacy and quality and international recommendations (eg. WHO; ICH)
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-
Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Overview of marketing authorisation components and objectives: part I
Objective: discuss key components, types of medicines and pathways and regulatory steps (eg. safety and efficacy components - FDA; EMA)
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-
Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Overview of Marketing Authorisation components and objectives: part II
Objective: interpret and discuss examples of review reports and summary of product characteristics (SPC) (eg. safety and efficacy components - FDA; EMA)
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-
Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Evidence supporting marketing authorisation: before and after approval.
Objective: discuss the marketing authorisation implications related to different steps related to development, approval, health technology assessment, pricing and reimbursement.
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-
Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Implications of marketing authorisation for different stakeholders: communication and information.
Objective: discuss possible implications of different approval pathways (eg. accelerated approval), sources and the importance of communication and information for different stakeholders.
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-
Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
|
Auditorium
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2
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Topics
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State Agency of Medicines. Registration of medicinal products in the EEA. Documents regulating marketing authorisation.
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Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
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Topics
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Common Technical Documentation (CTD). Notice to Applicants. Regulations of the Cabinet of Ministers of the Republic of Lithuania No. 376 "Registration of medicines". Cabinet Regulation No. 376. Procedures for the Registration of Medicinal Products.
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Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Changes in drug information. Cabinet Regulation No. 57 Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for the Package Leaflet of Medicinal Products
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-
Class/Seminar
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Changes in drug information. Cabinet Regulation No. 57 Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for the Package Leaflet of Medicinal Products
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-
Class/Seminar
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Laboratory
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2
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Topics
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Checking and updating of the summary of product characteristics, instructions for use and labelling according to the standards (Templates) prepared by EMA. Labeling.
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Lecture
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Veterinary medicines, medical devices, food supplements, cosmetics, other products.
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-
Class/Seminar
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Modality
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Location
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Contact hours
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|---|---|---|
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On site
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Auditorium
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2
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Topics
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Verification of the Food supplement composition. Health indications.
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-
Class/Seminar
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Modality
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Location
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Contact hours
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|---|---|---|
|
On site
|
Auditorium
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2
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Topics
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Food supplement registration/notification
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-
Class/Seminar
|
Modality
|
Location
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Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
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Topics
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Medical devices - classification and impact on market realization.
|
-
Class/Seminar
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Modality
|
Location
|
Contact hours
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|---|---|---|
|
On site
|
Auditorium
|
2
|
Topics
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Medical devices - classification and impact on market realization.
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Total ECTS (Creditpoints):
3.00
Contact hours:
32 Academic Hours
Final Examination:
Exam (Written)
Bibliography
Required Reading
1.
LR MK noteikumi nr. 57 "Noteikumi par zāļu marķēšanas kārtību un zāļu lietošanas instrukcijai izvirzāmajām prasībām".
2.
LR MK noteikumi nr. 376 “Zāļu reģistrēšanas kārtība“.
3.
LR MK noteikumi nr.685. Prasības uztura bagātinātājiem.
4.
LR MK noteikumi nr. 600 "Veterināro zāļu reģistrēšanas kārtība“.
5.
LR MK noteikumi nr. 326 "Veterināro izplatīšanas un kontroles noteikumi“.
6.
IQVIA. Global use of medicines 2024: Outlook to 2028. 2024.
7.
European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
8.
World Health Organization (WHO). 02. Registration and Marketing Authorization (MA): Indicators and Fact Sheets. In: WHO Global Benchmarking Tool ( GBT ). Geneva: WHO, 2021: 74–114
9.
World Health Organisation (WHO). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Good regulatory practices in the regulation of medical products. WHO TRS no.1033, 2021; 39.
10.
World Health Organization (WHO). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 9 Good review practices: guidelines for national and regional regulatory authorities. WHO Tech Rep Ser 2015; 191–210.
11.
World Health Organization (WHO). Guidelines: Norms and Standards for Pharmaceuticals.
12.
Behmane D, Viksna A, Gulbe A. LATVIA Pharma Profile, November 2008. Austria, 2009
13.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Guidelines.
14.
Eichler H-G, Enzmann H, Rasi G. Added therapeutic benefit and drug licensing. Nat Rev Drug Discov 2019; published online April 11.
15.
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.
16.
Volume 2B Notice to Applicants. Medicinal products for human use. 2008. (akceptējams izdevums)
17.
Ārvalstu studentiem/For international students:
18.
European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.
19.
World Health Organization (WHO). 02. Registration and Marketing Authorization (MA): Indicators and Fact Sheets. In: WHO Global Benchmarking Tool ( GBT ). Geneva: WHO, 2021: 74–114
20.
IQVIA. Global use of medicines 2024: Outlook to 2028. 2024.
21.
World Health Organisation (WHO). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Good regulatory practices in the regulation of medical products. WHO TRS no.1033, 2021; 39.
22.
World Health Organization (WHO). WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 9 Good review practices: guidelines for national and regional regulatory authorities. WHO Tech Rep Ser 2015; 191–210.
23.
World Health Organization (WHO). Guidelines: Norms and Standards for Pharmaceuticals.
24.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Guidelines.
25.
Eichler H-G, Enzmann H, Rasi G. Added therapeutic benefit and drug licensing. Nat Rev Drug Discov 2019; published online April 11.
26.
Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.
Additional Reading
1.
Wouters OJ, Berenbrok LA, He M, Li Y, Hernandez I. Association of Research and Development Investments With Treatment Costs for New Drugs Approved From 2009 to 2018. JAMA Netw open 2022; 5: e2218623
2.
Landhuis E. The Definition of Gene Therapy Has Changed. Nature 2021.
3.
Kang HN, Thorpe R, Knezevic I, et al. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019. Biologicals 2020; 65: 1–9
4.
International Society of Drug Bulletins (ISDB). ISDB declaration on therapeutic advance in the use of medicines. Prescrire. 2001; 39: 135–46.
5.
Naci H, Davis C, Savović J, et al. Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis. BMJ 2019; 366.
6.
Lexchin J. New drug submissions in Canada and a comparison with the Food and Drug Administration and the European Medicines Agency: Cross-sectional analysis. PLoS One 2023; 18: 1–10
7.
Seligman WH, Fialho L, Sillett N, et al. Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: A report of the International C. BMJ Open 2021; 11.
8.
Subbiah V. The next generation of evidence-based medicine. Nat Med 2023; 29: 49–58.
9.
Panteli D, Arickx F, Cleemput I, et al. Pharmaceutical regulation in 15 European countries Health Systems in Transition. 2016; 18.
10.
Naci H, Salcher-Konrad M, Kesselheim AS, et al. Generating comparative evidence on new drugs and devices before approval. Lancet 2020; 395: 986–97
11.
Cipriani A, Ioannidis JPA, Rothwell PM, et al. Generating comparative evidence on new drugs and devices after approval. Lancet 2020; 395: 998–1010
12.
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: Systematic review. BMJ 2017; 357.
13.
Beaver JA, Pazdur R. “Dangling” Accelerated Approvals in Oncology. N Engl J Med 2021; 384: e68.
14.
Ivama-Brummell AM, Marciniuk FL, Wagner AK, et al. Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis. Lancet Reg Heal - Am 2023; 22.
15.
Davis C, Wagner AK, Salcher-Konrad M, et al. Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe. BMJ 2023.
16.
Wieseler B, McGauran N, Kaiser T. New drugs: Where did we go wrong and what can we do better? BMJ 2019; 366.
17.
Salmane Kulikovska I, Poplavska E, Ceha M, Mezinska S. Use of generic medicines in Latvia: Awareness, opinions and experiences of the population. J Pharm Policy Pract 2019; 12: 1–7.
18.
Leufkens HG, Kusynová Z, Aitken M, et al. Four scenarios for the future of medicines and social policy in 2030. Drug Discov Today 2022; 27: 2252–60
19.
Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
20.
Gibson, M. 2009. Pharmaceutical preformulation and formulation: A practical guide from candidate drug selection to commercial dosage form
21.
Rowe, R. C. 2020. Handbook of pharmaceutical excipients / edited by Raymond C. Rowe [et al.]. 7th ed. London; Philadelphia: Pharmaceutical Press; Washington, DC: American Pharmaceutical Association.
22.
Florence, A. T. 2016. Physicochemical principles of pharmacy: In manufacture, formulation and clinical use / Alexander T. Florence and David Attwood. 6th ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
Other Information Sources
1.
Eiropas Zāļu Aģentūras (EMA) izdotas vadlīnijas