The Master’s study cycle in Regulation and Evaluation of Medicines and Health Products lasts 2 academic years, organized into 4 semesters, and aims to train specialists in the regulatory affairs of medicines (“Regulatory Affairs”) integrated with the scientific components of its life cycle.
This course aims to increase de knowledge on all the regulatory aspects, laws and directives, science based approaches on the Marketing authorisation in European Union for Medicinal Human Medicines and Veterinary Medicines. Furthermore, this course will include legislation in Health Products based on Medicinal Plants, Medical Devices as well as patent laws, price regulation and others.
This course will also guarantee the training of professionals that can work and solve complex issues in regulatory affairs and can contribute to optimize decision making process.
Teaching Language
The classes are per default lectured in Portuguese unless non-Portuguese speaking applicant is admitted. If a non-Portuguese speaking applicant is admitted, the great majority of lectures will be spoken in English. The large majority course contents and materials are written in English.
ECTS
120 ECTS:
60 – correspond to the first two semesters.
60 – correspond to the Dissertation.
Duration
2 academic years / 4 semesters
Regime
After-work
The course trains specialists in Regulatory Science, conferring general and specific knowledge about the studies that are part of the drug development from small molecules to biotechnological drugs or gene or cellular basis, in the perspective of technical-scientific and regulatory requirements in terms of studies and methodologies.
These specialists will have competencies to carry out professional activities in Regulatory Drug Agencies, in Research and Regulation Departments of Pharmaceutical Industries, as well as in the Research Institute of Medicine and in the Academy.
Classes will be held on Thursday from 6:30 p.m to 9:30 p.m, on Fridays from 6:00 p.m. to 9:30 p.m., and on Saturdays from 9:00 p.m. to 5:30 p.m. During the period of evaluations the schedule is set.
The classes will take place at the Faculty of Pharmacy of the University of Lisbon.
2025/2026
Full-time general student
National Students
Annual fee: 4.500,00 € (1st year) | 1.000,00 € (2nd year)
International students
Annual fee: 4.500,00 € (1st year) | 1.000,00 € (2nd year)
(Passed/assessed — academic year 2024/2025)
Source: FenixEdu, April 2026
(Failed/assessed — academic year 2024/2025)
Source: FenixEdu, April 2026
Graduates from 2019/20 to 2023/24
* Calculated as the difference from the percentage of graduates registered as unemployed with the IEFP.
This does not represent an employment rate.
Source: DGEEC, data from June 2025 (2026 edition)
View more indicators on the InfoCursos Portal
Postgraduate Studies Office: mestrados@ff.ulisboa.pt
Decision of the A3ES Management Board 