Lead Executive Office Profile
Medicines Evaluation and Marketing Authorization (MEMA) Lead Executive Office is a section under the Deputy Director General of the Medicine Sector, responsible for assessing the quality, safety and efficacy of human medicines. MEMA performs the following functions in regulation of medicines in fulfillment of the Authority’s mission of protecting and promoting public health:
- Evaluating applications for the registration of medicinal products;
- Registering medicines that meet the required quality, safety and efficacy standards;
- Reviewing and approving medicinal product labeling and information;
- Updating and publishing information on registered medicines;
- Evaluating and approving promotional materials and advertisements applied for registered medicinal products;
- Developing and reviewing strategies, guidelines, standard operating procedures (SOPs) and manuals related to medicines;
- Attending and responding to customer enquiries related to medicines registration;
In carrying out these functions, MEMA collaborates with the Medicine Manufacturers Inspection and Enforcement Lead Executive Office, the Medicine Quality Control Lead Executive Office, the Pharmacovigilance and Clinical Trials Lead Executive Office, Branch Offices, and other relevant entities to address matters concerning the quality, safety, and efficacy of registered products on the market.