Open AccessVaccines regulation in Malaysia
Author(s) -
Jenny Thong Chen Ni
Publication year - 2019
Publication title -
international journal of research in pharmaceutical sciences
Language(s) - English
Resource type - Journals
ISSN - 0975-7538
DOI - 10.26452/ijrps.v10ispl1.1693
Subject(s) - licensure , agency (philosophy) , regulatory agency , presentation (obstetrics) , medicine , quality (philosophy) , christian ministry , business , public administration , political science , nursing , surgery , philosophy , epistemology , law
The National Pharmaceutical Regulatory Agency (NPRA) is the regulatory body under the Ministry of Health (MOH) that regulates medicines (including vaccines) and cosmetics in Malaysia. NPRA is the organization body that safeguards the public health by ensuring medicines that are authorized to be in the Malaysian market are of quality, efficacious, and safe. The presentation will be focusing on the key areas in regards to vaccine regulations, including the registration pathway of vaccine, the requirements of registration of a vaccine in terms of quality, efficacy, and safety, and post-licensure activity for the vaccine (vaccine lot release). In addition, the presentation would also provide some relevant information, including the brief process of vaccine manufacturing, the contents of a vaccine, and also a case study encounter during the vaccine lot release commencement.