製薬業界が進化し続けるにつれ、薬事申請のプロセスも進化しています。重要な進展の一つは、eCTD (Electronic Common Technical Document) 4.0 の導入です。(eCTDを詳しくご存知ない方は、このブログをお読みください）。つづく...
Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)), and elsewhere. But developing each submission independently can waste a lot of time and money. Fortunately, there are ways to maximize the reusability of your … Continued
What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The … Continued
The eCTD struggle is real. Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing. In this blog post, … Continued
In helping clients with their regulatory operations and electronic publishing needs, I’m often asked about preparing regulatory submissions in the electronic common technical document (eCTD) format. While a lot of us have been working in the eCTD format for many years, new start-up companies focusing on rare diseases and new technologies to treat patients are … Continued