Health Canada announced that fees related to Master Files (MFs)—which provide confidential information about processes or components used in the Read more about Health Canada Announces New Master File Fees
Earlier this month, the Food and Drug Administration (FDA) Read more about FDA Issues Guidance on Regulatory Submissions in Alternate Electronic Format, Including Type III DMFs
The Food and Drug Administration (FDA) has issued final guidance that exempts Type III Drug Master Files (DMFs), which cover drug packaging and Read more about FDA Permanently Exempts Type III DMFs for Drug Packaging Materials from eCTD Format Requirement
Health Canada has extended the deadline for mandatory filing of new Master Files (MFs) in electronic Common Technical Document (eCTD) format to Read more about Health Canada Extends Deadline for Mandatory Filing of Type II Master Files in eCTD to 2020
China first established a Drug Master File (DMF)-type system for the registration of drug packaging materials, active pharmaceutical ingredients ( Read more about China Amends DMF System on Drug Packaging
