Draft Guidance on Implementing GDUFA II By FDA

The US FDA revised draft guidance on the generic drug user fee program (GDUFA II) which serves the new fee structure and types of fees will be assessed. (more…)

MHRA Offers Guidance on Comparator products in BE/TE studies after Brexit

MHRA provides No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies. This guidance provides further information on comparator products used in studies supporting abridged marketing authorisation applications in a no-deal Brexit. (more…)

FDA Guidance on Submitting Manufacturing Facility Information

The US Food and Drug Administration (FDA) finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. (more…)

EMA Issues Guideline for Wording of Therapeutic Indication

The European Medicines Agency (EMA) released a guidance developed by Committee for Medical Products for Human Use (CHMP) on the wording of therapeutic indications is consistent across products. (more…)

FDA Revised Draft Guidance on Drug Master Files

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Drug Master Files.” Once finalized, this guidance will provide FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. This draft guidance, when finalized, will revise the guidance for industry “Drug Master Files: Guidelines” that published in September 1989. (more…)

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…)