Transcript · English → Indonesian
Pharmaceutical Approval Process During Pandemic
Perusahaan farmasi harus membuktikan bahwa suatu produk aman sebelum produk itu
memasuki pasar. Jadi, Anda membuktikan keamanannya, dan itu dilakukan melalui
pengujian ketat. Pengujian tersebut mencakup pemeriksaan
klinis.
Itu mencakup, Anda tahu, pemeriksaan laboratorium. Anda akan mencari biomarker.
Anda akan melakukan pengujian ekstensif. Uji coba itu akan membutuhkan waktu bertahun-tahun untuk diselesaikan
dan kemudian pada
akhir uji coba, Anda akan melihat hasilnya,
dan Anda akan dapat mengatakan,
"Apakah ini aman atau tidak, dan apakah ini memenuhi standar untuk, um,
persetujuan regulasi?" Namun, selama pandemi, karena ini adalah
krisis kesehatan masyarakat, sebuah kerangka darurat baru
diberlakukan, dan mereka dapat melakukan persetujuan berdasarkan
apa yang mereka sebut
tinjauan bergulir. Dan tinjauan bergulir pada dasarnya berarti
bahwa Anda dapat mengambil
melihat sekilas hasil uji coba, dan jika ada tanda awal manfaat,
maka Anda
benar-benar bisa menyetujui produk itu berdasarkan data awal tersebut.
Jadi produk-produk ini disetujui berdasarkan data dua bulan
End of transcript · 150 words · machine translated
Original transcript (English)
A pharmaceutical company would have to prove that a product was safe before it accessed the market. So you prove safety, and you do that through rigorous testing. The testing would include clinical examinations. It would include, you know, lab work. You'd look for biomarkers.
You'd do extensive testing. It would take years to complete that trial, and then at the end of the trial, you would look at the results, and you would be able to say, "Is it safe or is it not, and does it meet the standards for, um,
regulatory approval?" However, during the pandemic, because this was a public health crisis, a new emergency framework was put in place, and they were able to conduct approvals based on what they call rolling reviews. And a rolling review basically means
that you get to take sneak peeks at the trial, and if there's an early sign of benefit, then you actually get to approve the product based on that early data. So these products were approved based on two months of data
