Postgraduate Programs 2024/25
Master of Science in Drug Regulatory Affairs and Policy
Award Title

Master of Science in Drug Regulatory Affairs and Policy

Program Short Name


Mode of Study

Both full-time and part-time

Normative Program Duration

Full-time: 1 year

Part-time: 2 years

Program Fee


Program Advisor

Program Director:

Prof Karl TSIM, Chair Professor of Life Science


The Master of Science (MSc) Program in Drug Regulatory Affairs and Policy is a high-quality program offering training for drug regulatory affairs and policy professionals which is critical for Hong Kong and the Greater Bay Area. Establishment of the Hong Kong Centre for Medical Products Regulation (CMPR) is one of the highlights in the HKSAR Policy Address 2023. The office is set up to study the potential restructuring and strengthening of the current regulatory and approval regimes for medicine, medical devices and medical technology to accelerate the approval of applications and registration of pharmaceutical products for launching to the market. The program is unique for preparing students to become top managers and main practitioners of the guidance documents, laws, and regulations for pharmaceutical companies and/or government agencies. With this training and exposure, graduates from the program will be able to manage regulatory affairs positions at pharmaceutical, biotechnology, medical device, diagnostic and healthcare products companies, and government agencies in their careers.

On successful completion of the program, graduates will be able to:

  1. Understand the rationale behind, and basic management practices of, quality control and quality assurance of pharmaceutical product development.
  2. Develop a thorough understanding on the relevant laws/regulations and/or regulatory environment of drug registration in China or US market;
  3. Gain professional training in keeping up with the increasing scope and complexity of the governmental regulations;
  4. Enhance good personality and communication skills in pharmaceutical regulations and policy;
  5. Serve as the top management and become main practitioners of the laws and regulations for pharmaceutical companies and/or government agencies; advising them on the regulatory aspects and climate that would affect their proposed activities; and
  6. Ensure that the pharmaceutical companies comply with the regulations of NMPA or FDA drug registration and laws pertaining to their business, and work with central, provincial and local regulatory agencies and personnel on specific issues affecting their business.


Last update: 22 Mar 2024

  1. Minimum Credit Requirement

    30 credits 

  2. Required Courses

12 credits

DRAP 5001
DRAP 5002
DRAP 5003
DRAP 5004
  1. Elective Courses

18 credits

Students are required to take at least three DRAP courses from the following list:

BTEC 5220
BTEC 5340
BTEC 5380
BTEC 5550
DRAP 5101
DRAP 5102
DRAP 5103
DRAP 5104
DRAP 5105
DRAP 5106
DRAP 6201
DRAP 6202
EEMT 5260

To qualify for admission, applicants must meet all of the following requirements. Admission is selective and meeting these minimum requirements does not guarantee admission.

1. General Admission Requirements of the University
  • Applicants seeking admission to a master's degree program should have obtained a bachelor’s degree from a recognized institution, or an approved equivalent qualification.

2. English Language Admission Requirements

Applicants have to fulfill English Language requirements with one of the following proficiency attainments:

  • TOEFL-iBT: 80 *

  • TOEFL-pBT: 550

  • TOEFL-Revised paper-delivered test: 60 (total scores for Reading, Listening and Writing sections)

  • IELTS (Academic Module): Overall score: 6.5 and All sub-score: 5.5 *

* Refers to scores in one single attempt only. Test at home option is not accepted.

Applicants are not required to present TOEFL or IELTS score if

  • their first language is English, or

  • they obtained the bachelor's degree (or equivalent) from an institution where the medium of instruction was English.

3. Program-Specific Admission Requirements
  • A bachelor's degree or above in life sciences, business management, engineering, health science, law, computer sciences, mathematics, and other relevant disciplines.

4. Additional Information
  • Relevant work experience in areas such as pharmaceuticals, medical devices, or health-related industry will be highly favorable.

Last update: 22 Mar 2024

Apply online before the application deadlines.


Application Fee


Application Deadlines

For 2024/25 Fall Term Intake (commencing in Sep 2024):

Non-local Applicants*
Full-time: 1 Jun 2024

Part-time: 1 Jun 2024


Local Applicants
Full-time: 15 Jul 2024

Part-time: 15 Jul 2024

 * Applicants are considered as non-local students if they hold (i) student visa/ entry permit; or (ii) visa under the Immigration Arrangements for Non-local Graduates (IANG); or (iii) dependent visa/entry permit who were 18 years old or above when they were issued with such visa/ entry permit by the Director of Immigration. For details on student visa/ entry permit requirements, please click here.