PRA700 - Introduction to Pharmaceutical Regulatory Affairs

Outline info
Last revision date 2018-07-20 11:50:20.065
Last review date 2018-07-20 11:50:49.9

Subject Title
Introduction to Pharmaceutical Regulatory Affairs

Subject Description
This subject describes the role of the Regulatory Affairs department in a pharmaceutical organization and focuses on the submission process and the legal requirements that control the process for pharmaceuticals, natural health products and medical devices.  The regulatory requirements at the various stages in a drug product development from inception through CTD (Common Technical Document) Clinical stage and NDS (New Drug Submission) application to issuance of the NOC (Notice of Compliance) and Post -NOC Amendments are examined. 

Credit Status
This is a credit toward the Ontario 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:

  1. Describe the role of the Regulatory Affairs department in a pharmaceutical firm, its relationship to other departments in the firm and to external regulatory bodies.
  2. Describe the development stages of a drug product or medical device and the corresponding legislated submission requirements.
  3. Implement those sections of the drug legislation in which the Regulatory Affairs department is routinely involved, for example: recall, complaint handling and ADRs, SOPs, regulatory inspections, and deficiency correction.
  4. Describe current legislation for patents, trademarks and copyrights and how it affects the submission approval process.
  5. Characterize Post-NOC Changes and SU/PAC Changes based on the requirements of the Therapeutics Products Directorate (TPD) and the Food and Drug Administration (FDA).
  6. Prepare an acceptable submission for a DINA Application in Non-eCTD Electronic format and Establishment Licence (EL). 
  7. Apply  the various sections of a drug submission and the regulatory requirements related to them in preparing requisite forms and communications.
  8. Compare the submission requirements for a Natural Health Product with classical pharmaceutical applications.
  9. Explain the Canadian and U.S. submission filing requirements for a Medical Device.  

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.

Admission to the program

Topic Outline

  • Welcome to the subject and program
  • Introduction to the pharmaceutical associations
  • Introduction to the pharmaceutical industry
  • Establishment licensing
  • DIN applications,  drug legislation and the CTD
  • Labelling regulations
  • Health Canada, Health Protection Branch, & Therapeutic Products Programme
  • Introduction to the Food & Drugs Act and Regulations
  • Clinical trials
  • Introduction to the drug development cycle
  • Submissions - CTA, IND and NHP's and Homeopathic drugs
  • Medical Devices
  • Patents
  • NDS - The CTD
  • Stability
  • Validation
  • Specifications and analytical methods
  • Pharmacopeial references
  • Drug review process
  • Special access program
  • Post-NOC Control (Notifiable Changes)
  • Labelling legislation & guidelines
  • Advertising
  • Cross border pharmaceutical purchases

Mode of Instruction
Lectures and assignments

Prescribed Texts
Canada's Food and Drugs Act, Author: SBSAC, Seneca College.  Edition: 1. Bar Code – 889000162334 Sku # 00267164B  01 

Reference Material

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.

General Policies and Guidelines

Cell Phone Usage
As a courtesy to your fellow students and faculty, cell phones should remain turned off while in class. If, in the case of an emergency, the cell phone must remain on, please notify the teacher before class begins.

Information Technology Acceptable Use Policy
All students are responsible for abiding by the College's Information Technology Acceptable Use Policy and for obeying Provincial and Federal laws/regulations regarding the use of computer equipment, facilities and/or networks.

Grading is based on the following marking scheme:
Term Test 15%
Assignment:  Label Development
Assignment:  DINA Submission
Assignment:  EL Submission 15%
Assignment:  Submission Plans 10%
Assignment:  Deficiency Response 10%
Assignment:  Medical Device Classification  10%
Post-NOC Documentation 10%

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