National Institute of Food and Drug Safety Evaluation established and published the Guidance on Authorization and Evaluation of Human papillomavirus Vaccines that incorporates the latest information to be considered for quality, safety and efficacy assessments of Human papilloma virus vaccine on 29th, Nov.

※Human papilloma Virus(HPV) : HPV is the most common sexually transmitted infection(STI). HPV is a different virus than HIV and HSV (herpes). There are many different types of HPV. Some types can cause health problems including genital warts and cancers. But there are vaccines that can stop these health problems from happening.

This guidance aims to help vaccine manufactures with their efforts to commercialize HPV vaccine by presenting review and approval requirements. Major contents in this guidance including ▲considerations for control of the manufacturing process, ▲objectives of the nonclinical/clinical evaluation, ▲post-marketing and so on.

I. Introduction

II. General Considerations

• Glossary

III. Manufacturing and Quality Control

• General manufacturing guidelines
• Control of starting/source materials

IV. Non-clinical Evaluation on Recombinant HPV VLP Vaccine

• Product development and characterization
• Pharmacodynamics
• Toxicity studies

V. Clinical Evaluation on Recombinant HPV VLP Vaccine

• ICP(Immunological correlate of protection
• Efficacy
• Safety
• Pharmacovigilance

VI. Conclusion

VII. Reference

Dynamic BIO Workshop

Dynamic BIO Workshop was held at Grand Convention Center (located at Yeongdeungpo-gu, Seoul) on 28th, Nov.

※ Dynamic BIO: Dynamic BIO is a consortium composed of experts from industry, government, and academia. It established for the purpose of supporting biopharmaceuticals industry and strengthening communication with pharmaceutical companies. Experts in the biopharmaceuticals sector participate to discuss policy and institutional improvement.

The workshop was prepared to share the result of operating Dynamic BIO in 2017 and discuss ways to advance the biopharmaceuticals industry. More than 150 biopharmaceutical professionals participated to promote communication among industry, academia and the government.

The workshop was composed of ▲announcement on the result of operating Dynamic BIO in 2017 ▲sectoral discussion and ▲presentation on biopharmaceuticals policy. Especially, at this time, the new program “window of communication” was launched to solve problems of industry through face-to-face counseling between petitioner related to biopharmaceuticals sector and the MFDS.

After the workshop, Bio-Update was held at the same place to explain regulations on approval and evaluation of biopharmaceuticals. The Bio-Update was composed of sessions including ▲major works related to biopharmaceuticals approval and evaluation in 2017, ▲presentation on guidelines on biopharmaceuticals established and revised in 2017 (related to biological products, recombinant protein products, cell & gene therapy products) and ▲ Q&A session.