IRA815 - International Regulatory Affairs and Harmonization

Outline info
Last revision date 2018-07-20 11:48:15.09
Last review date 2018-07-20 11:48:22.959

Subject Title
International Regulatory Affairs and Harmonization

Subject Description
This subject provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in European countries, Japan and USA are examined as well as the regulations in a selected number of other geographic locations. Specification criteria and tests with drug substances and drug products are compared and the reasons behind regulations and controls are examined.

Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

Learning Outcomes
Upon successful completion of this subject the student will be able to:

Appreciate the need for global harmonization  
Describe the ICH (International Conference on Harmonization) and demonstrate a familiarity with the past and current issues being addressed by the ICH and understand the history of the ICH Meetings and Conferences.  
Describe the regulatory process of pharmaceutical products in the USA, Europe, Japan and those in major locations.  
Demonstrate a familiarity with specific tests and criteria that are part of ICH guidelines.   
Describe the implementation of Mutual Recognition Agreements (MRA) between countries.  
Understand the differences in the regulatory environment around the world and appreciate the importance of emerging markets in the growth of pharmaceutical marketing and regulatory affairs profession.  
Describe and compare the regulatory process of pharmaceutical products in emerging markets  

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on for further information regarding cheating and plagiarism policies and procedures.

All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.


Topic Outline
Topic and Class Activity
Course Overview
History of Regulatory Affairs
ACTIVITY: Team/group formation and course information.

Herbal Medicines
International Conference on Harmonization (ICH) and WHO
Introduction to CTD
Overview of CTD and commonalities and differences of EU, FDA and Japan CTD
In-class explanation of Module 2 of the EU CTD-discussion on preparation of a CTD MODULE

Quality overall summary & Focus on Europe
EU Regulations Part 1 and 2
CLINICAL TRIALS – International perspectives.

Testing procedures – regulatory requirements:
Stability Testing and 2. Bioequivalence studies. 3. Tablet Testing
Colourants/Preservatives and sweeteners regulations
Drug Master Files Part 1  and Part 2

FDA Discussion
Generic Registrations by FDA       
The CTD around the world ( discussion and examples)       
Australia -          

BSE Background and regulatory effects

Patent regulations

Cosmetics – manufacture, advertising and regulatory issues
Regulations for: Japan, China, Hong Kong, India 

Regulations for: Ivory Coast, Ghana, Kenya South Africa, Persian Gulf States, Jordan, Russia and adjoining states.

Regulations for Central and South American countries and the Caribbean
Overview: Radiopharmaceuticals

Amendments to the dossier – regulatory procedures for changes in the documentation, changes in formulation and drug substance source.
Medical Devices

Mode of Instruction
Lectures, exercises, group discussion and assignments 

Prescribed Texts

Reference Material
IMPORTANT: Readings; The following readings will form the basis for class discussion and assignment.


1.   Modernizing The FDA: An Incremental Revolution

2.   The FDA Modernization Act of 1997: Impact on Pediatric Medicine

3.   FDA Amendments Act of 2007

4.   Emerging Challenges and Opportunities in Drug Registration and Regulation in.Developing Countries.



7.   Colourants:

8.   EU Exlusivity\


Additional articles and handouts will be provided during the term.

Required Supplies

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online ( or at Seneca's Registrar's Offices.

Modes of Evaluation

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:

Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed.

Grading is based on the following marking scheme:
Assignments 30%
Group Presentation 25%
CTD Exercises (take home) 15%
Examination 30%

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.


Approved by: Denis Gravelle