Main Article Content
Vaccines contain agents which are often made from the microbe or its surface proteins or its toxins, which are eventually derived from the biological source. Before launching a new vaccine in the market, the rigorous regulatory procedure is required to assess the quality, efficacy and safety of the vaccine. Saudi Arabia registration of vaccine procedure is done under the marketing authorization of Saudi Food and Drug Administration (SFDA). Registration of vaccines guidelines in Singapore is categorized under Therapeutic product registration. NDA (New Drug Application) application must be filed for registering the vaccines in Singapore.
This study was aimed to bring out information about the registration procedures amongst the guidelines from Saudi Arabia and Singapore and concluding from the fact that how these guidelines can be harmonized. The harmonized registration procedure is required to ensure the reachability of the vaccines on time to the global population.
Vaccine Development, Testing, and Regulation. Available:https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation (accessed 5th march 2020)
SFDA. Saudi food and drug authority.
Available:https://old.sfda.gov.sa/en/pages/default.aspx (accessed 07th March 2020).
HSA. pharmaceutical regulatory information system (PRISM).
Available:https://www.hsa.gov.sg/e-services/prism (accessed 15th march 2020).
Hsa.gov.sg. Understanding Vaccines, Vaccine Development and Production.
Available:https://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Consumer_Information/Public_Advisories/Influenza_A_H1N1_information/H1N1_Vaccines/understanding-vaccines--vaccine-development-and-production.html (accessed 25th October 2018).
SFDA. Saudi Food & Drug Authority Product Conformity Assessment Program.
Available:https://www.sgsgroup.fr/-/media/local/france/documents/brochures/sgsgispcasaudi-arabiadatasheet-sfda16v5cosmetiques.pdf (accessed 10th April 2020).
SFDA.SFDA- Regulatory Framework for Drug Approvals.
Available:https://sdr.sfda.gov.sa/images/Regulatory_Framework_for_Drug_Approvals_v_5.pdf (accessed 25th May 2020).
SFDA. SFDA- Guidance for submission.
Available:http://www.alshedwygp.com/wp-content/uploads/2015/03/Guidance_for_Submission_v_4-0.pdf (accessed 14th May 2020).
Executive board of the health ministers’ council for GCC States. The GCC Guidance for Presenting the SPC, PIL and Labeling Information.
Available:https://old.sfda.gov.sa/en/drug/drug_reg/Regulations/Guidance%20for%20SPC%20PIL%20SFDA%20version%202.0.pdf (accessed 10 September 2020).
Eun-Ha Kim1, Hyeok-Il Kwon1, Su-Jin Park1, Young-Il Kim1, Young-Jae Si1, In-Won Lee1, Se mi Kim1, Soo-In Kim2, Dong-Ho Ahn2, Young-Ki Choi1*. Generation of a high-growth influenza vaccine strain in MDCK Cells for Vaccine Preparedness. J. Microbiol. Biotechnol. 2018;28(6).
HSA. Fees and turnaround time for therapeutic products.
Available:https://www.hsa.gov.sg/therapeutic-products/fees (accessed 10th September 2020).
HSA. Guidance on therapeutic product registration in singapore – target processing. Available:https://www.hsa.gov.sg/docs/default-source/hprg/therapeutic-products/guidance-documents/appendix-5_target-processing-timeline.pdf (accessed 15th August 2020).
HSA. Guidance on Therapeutic Product Registration in Singapore – Points to Consider for Singapore Labelling. .
Available:https://www.hsa.gov.sg/docs/default-source/hprg/therapeutic-products/guidance-documents/appendix-7_points-to-consider-for-singapore-labelling.pdf (accessed 15th August 2020).
Soundarya Reddy Kalva,Sahitya Reddy Kalva, Sudheer Kumar Gumme. Regulatory architecture of biosimilars in Singapore: A critical overview. International Journal of Drug Regulatory Affairs September 2019;7(3).