FDA Finalizes Guidance on PDUFA Fee Waivers, Reductions and Refunds

The US Food and Drug Administration (FDA) finalized guidance providing advice to drug and biologic sponsors looking to apply for Prescription Drug User Fee Act (PDUFA) fee waivers, reductions and refunds. (more…)

Malaysia Revised Drug Registration Process Guidance

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has revised its drug registration guide. The updated document addresses quality control, inspections and other steps in the drug registration process and features product-specific labeling requirements for eight more therapies than its predecessor. (more…)

China Releases Draft eCTD Submission Information

China’s Center for Drug Evaluation (CDE) has released draft information regarding the future of electronic common technical document (eCTD) submissions in China. While things may change between this draft information and the final specification. (more…)

eCTD is mandatory for CEP Applications From 01 January 2020 to EU

The eCTD is mandatory for ALL CEP applications to EDQM including notifications, revision, renewal and new applications from 1 January 2020. (more…)

From 01 September 2019, eCTD Format For Dossier Submission Will Be Mandatory For The Health Canada

Health Canada has been accepting regulatory activities in eCTD format since 2004. Now Health Canada will accept dossiers in eCTD format only from 01 September 2019 for the following applications. (more…)