In an announcement made April 24, 2017 Health Canada reaffirmed its intent to transition all regulatory submissions over to eCTD format.
Starting January 1, 2018 all New Drug Submissions (NDSs), Supplemental NDSs (SNDSs), Abbreviated Continue reading
In just a few days, May 5, 2017, the FDA will only accept eCTD formatted submissions for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs). Passing this milestone Continue reading
Electronic submissions have become the preferred method for submitting applications for post-authorization approval among the three regions that are party to the ICH. In February 2004, ICH M2 Expert Working Group has released the eCTD Continue reading
The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has Continue reading
Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.
As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.
This past year, we Continue reading
As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced Continue reading
On October 08, 2014, the FDA issued a draft guidance for industry entitled “Critical Path Innovation Meetings.” The Critical Path Innovation Meetings (CPIM) provides an opportunity for FDA’s Center for Drug Evaluation and Research (CDER) to discuss Continue reading
FDA has released two draft guidance documents on refuse to receive ANDA submissions. The purpose of the guidances are to help applicants prepare “ANDAs and PASs to ANDAs for which the applicant is seeking Continue reading
On October 23, 2014, Health Canada released a new Drug Establishment Licence (DEL) Application Form (FRM-033) with instructions. This form supersedes the Continue reading
The International Generic Drug Regulators Pilot (IGDRP) was created in 2012 to promote collaboration and convergence in generic drug regulatory programs in order to Continue reading