Regulatory Journey of Vaccine Development in the Philippines
Current Journal of Applied Science and Technology,
Page 17-31
DOI:
10.9734/cjast/2022/v41i1931740
Abstract
A vaccine is a biological preparation that induces active acquired immunity against a specific infectious disease. Vaccination is widely regarded as one of humanity's most significant achievements of the twentieth century. In terms of absolute significance, it is regarded as being on stake with some of the most significant medical science discoveries. vaccines for infectious diseases typically take years to develop because they are produced either by chemical inactivation of the virus or pathogen attenuation, processes that can take a long time to validate and also require the live pathogen.
Vaccines have been credited with reducing or eliminating a variety of infectious diseases, including smallpox, measles, and diphtheria. Vaccines proved to be timely interventions, particularly in countries such as the Philippines, where a large number of infectious diseases were prevalent. The Philippines FDA oversees the vaccine approval process in the Philippines.
Vaccines are subjected to rigorous testing and oversight throughout the development life cycle, from preclinical studies to post-licensure. To ensure vaccine quality, manufacturers must follow good manufacturing practises and control procedures.
This work attempted to outline the vaccine development journey and regulatory process beginning with the formulation and process development and concluding with commercialization (distribution).
Keywords:
- FDA (Philippines food and drug administration)
- vaccine
- formulation
- GMP
- GDP
- GCP
How to Cite
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