Quality Requirements for Medicines and Vaccines
Ensuring the quality of medicines is essential to protect public health. This involves a thorough evaluation of the data package provided by manufacturers during the Chemistry, Manufacturing and Controls (CMC) review, which includes detailed information on the medicine’s chemistry, formulation development, manufacturing process, quality control, packaging and storage condition. Manufacturers are required to comply with relevant international guidelines and demonstrate that adequate manufacturing controls and processes are in place to ensure consistency and the quality standards of medicines.
CMC is crucial for medicine regulation to ascertain the quality of medicines through proper development, stringent controls and testing. In her presentation, Dr Chuah Shin Chet will discuss the quality requirements for medicines and vaccines from the regulator’s perspective, with emphasis on the importance of adhering to the required scientific standards to ensure that medicines supplied in Singapore are of good quality and suitable for their intended use in our patients, and that any associated risks are minimised.