The Master of Science (MSc) Program in Drug Regulatory Affairs and Policy is designed to train professionals in drug regulatory affairs and policy, which are critical areas for Hong Kong and Greater Bay Area development. A notable highlight in the HKSAR Policy Address 2023 is the establishment of Hong Kong Centre for Medical Products Regulation (CMPR). The HKCMPR will be dedicated to potential restructuring and strengthening of current regulatory and approval regimes for medicine, medical devices and medical technology, in order to accelerate the approving applications and launching for registration of pharmaceutical products to the market. Our program is unique for preparing students to become proficient managers and main practitioners of guidance documents, laws, and regulations for pharmaceutical companies and government agencies. Upon completion of this program, graduates will be well-equipped to assume regulator y affairs positions in pharmaceutical, biotechnology, medical device, diagnostic and healthcare products companies, as well as government agencies.

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.
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.

1. Minimum Credit Requirement

   30 credits 
    

2. Required Courses

12 credits
 

3. Elective Courses

18 credits

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

4. Remarks

Part-time students may take a maximum of 9 credits in each term.

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

Apply online before the application deadlines.

The program has been selected by the University Grants Committee (UGC) to award eligible local students for the Hong Kong Future Talents Scholarship Scheme for Advanced Studies. For details, please refer to https://fytgs.hkust.edu.hk/ftss.​

 * 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.