Health Canada announced that fees related to Master Files (MFs)—which provide confidential information about processes or components used in the manufacturing, processing, or packaging of a drug—will increase by 2% as of April 1, 2020. The new Master File fees are:
Earlier this month, the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Alternate Electronic Format.” This Agency
The Food and Drug Administration (FDA) has issued final guidance that exempts Type III Drug Master Files (DMFs), which cover drug packaging and drug packaging materials, from the requirement to submit in Electronic Common Technical Document (eCTD) format. The exemption is included in the final guidance for industry, titled, "Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" (Revision 7), which FDA published this month.
Health Canada has extended the deadline for mandatory filing of new Master Files (MFs) in electronic Common Technical Document (eCTD) format to January 1, 2020. A September 13, 2019 Notice from Health Canada summarizes the mandatory eCTD format requirements for regulatory activities already implemented and ones that will become effective at a future date.
China first established a Drug Master File (DMF)-type system for the registration of drug packaging materials, active pharmaceutical ingredients (APIs), and drug excipients in Announcement No. 146 of 2017, published by the former China Food and Drug Administration (CFDA). Under the registration system, a company first needs to submit to the Center for Drug Evaluation (CDE) the registration dossier for a packaging material, API, or drug excipient and obtain a registration number.
The Food and Drug Administration (FDA) has announced that it considers Type III Drug Master Files (DMFs), which cover drug packaging and drug packaging materials, to warrant exemption from the electronic formatting requirements, also known as Electronic Common Technical Document (eCTD), being imposed on other types of DMFs.
In May 2018, Health Canada proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) format effective January 1, 2019. (See the PackagingLaw.com article, Health Canada Proposes Mandatory eCTD Formatted Master Files by 2019; Feedback Requested.) Comments on that proposal were due by August 10, 2018.
The U.S. Food and Drug Administration (FDA) has extended the requirement to submit all new Type III Drug Master Files (DMF) applications, as well as all documents submitted to existing DMFs, in Electronic Common Technical Document (eCTD) format, to May 5, 2020. Type III DMFs are for packaging materials.
Over the last twelve months, there has been a significant uptick in Consumer Product Safety Commission (CPSC) recalls of products that do not have required child-resistant closures. Under the Poison Prevention Packaging Act (PPPA), child-resistant packaging is required for prescription drugs, over-the-counter drugs, dietary supplements, and cosmetics that contain chemicals listed in CPSC's regulations. Since 1992, CPSC has conducted 28 recalls for PPPA violations.
Health Canada has proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) format effective January 1, 2019. The deadline for commenting on this proposal is August 10, 2018.
In a May 7, 2018 Notice announcing the proposal, Health Canada outlined several requirements for eCTD formatted submissions, including: