Drug Regulatory Affairs and Policy

Overview

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 Drug Regulatory Affairs and Policy program from The Hong Kong University of Science and Technology 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.

Learning outcomes

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

• Understand the rationale behind, and basic management practices of, quality control and quality assurance of pharmaceutical product development.

• Develop a thorough understanding on the relevant laws/regulations and/or regulatory environment of drug registration in China or US market;

• Gain professional training in keeping up with the increasing scope and complexity of the governmental regulations;

• Enhance good personality and communication skills in pharmaceutical regulations and policy;

• 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

• 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.