EMA COVID-19 vaccines against SARS-CoV-2(2019nCoV) studies for approval guidance

The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. As a public-health body safeguarding medicines in the European Union (EU), EMA will only approve a vaccine for COVID-19 after a thorough evalutation demonstrating the same high standards of quality, safety and efficacy required for any other vaccine approved in the EU.

FDA Guidance of Industy Documents download for new drug discovery,CMC manufacturing, gene therapy and cell therapy

FDA Guidance of Industy Documents download for new drug discovery,CMC manufacturing, gene therapy and cell therapy.

FDA & NIH Guidelines of viral vectors (AAV, lentivirus and adenovirus) and gene therapy

FDA & NIH Guidelines of viral vectors (AAV, lentivirus and adenovirus) and gene therapy