The U.S. Food and Drug Administration (FDA) announced on April 24, 2018, that the requirement to submit all new Type III Drug Master File (DMF) applications, as well as all documents submitted to existing DMFs, in Electronic Common Technical Document (eCTD) format will be extended by one year, from May 5, 2018 to May 5, 2019. This is the second time FDA has extended this deadline; last year, the Agency similarly announced a one-year extension just a few weeks prior to the original May 5, 2017 deadline.
The Food and Drug Administration's (FDA) requirement for Electronic Common Technical Document (eCTD) formatting for all submissions associated with drug applications, including Drug Master Files (DMFs), is scheduled to become effective on May 5, 2018.
Health Canada has released a final guidance document on “Master Files (MFs) – Procedures and Administrative Requirements.” The Guidance, released on April 28, 2017, replaces the 2008 Draft Guidance Document – Drug Master Files (DMFs).
The U.S. Food Drug and Administration (FDA) announced on April 7, 2017, that the requirement to submit all new Drug Master File (DMF) applications, as well as all documents submitted to existing DMFs, in Electronic Common Technical Document (eCTD) format will be extended by one year, from May 5, 2017 to May 5, 2018.
The U.S. Pharmacopeial Convention announced its intent to develop a new general chapter in the U.S. Pharmacopeia-National Formulary (USP-NF) related to packaging materials: Proposed <662> on Metal Packaging Components and their Materials of Construction. The chapter will be used to ensure the safety and suitability of metal packaging systems for pharmaceutical products, and will provide test methods and standards for metal materials and components that make up a primary packaging system.
The Food and Drug Administration (FDA) announced that it will hold a webinar on February 4, 2016, regarding the new requirements for electronic submission of Drug Master Files (DMFs). Most DMFs must be submitted electronically to FDA in electronic format beginning May 15, 2017.
Health Canada announced that by March 31, 2016, all existing Drug Master Files (DMFs) in paper format must be replaced by electronic copies.