MHRA Released Post-transition guidance on licensing medicines

The UK has left the EU, and the transition period after Brexit comes to an end this year. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.

From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.

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Swissmedic updated eCTD specification and validation criteria to version 1.5

Switzerland’s regulatory authority Swissmedic updated guidance on submitting regulatory information in eCTD format to the Swiss Agency for Therapeutic Products. (more…)

Implementation of Clinical Trials Regulatory Activities in eCTD Format Begins by Health Canada

After successful Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format in the pilot in August 2019, Health Canada begins implementation of Clinical Trials regulatory activities in eCTD format. (more…)

FDA’s eCTDv4.0 Technical Conformance Guide: Open for Comments

The FDA has finalized guidance documents on eCTD submission format for eCTDv4.0 Technical Conformance Guidance and the FDA eCTDv4.0 Module 1 Implementation Package. (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…)

Submission of an updated Risk Management Plan (RMP) to TGA (Therapeutic Goods Administration) Australia

TGA has updated RMP for the sponsors of prescription medicines and biologicals making applications to enter or vary Australian Register of Therapeutic Goods (ARTG) entries.

Therapeutic Goods Administration has provided form to be submitted along with updated RMP.

Use this form when submitting an updated RMP after regulatory approval. This form should be submitted in module 1.0.1 and the updated RMP in module 1.8.2.

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Jordan Food & Drug Administration (JFDA) started eCTD submissions

Moving towards to the paperless submission of dossier, JFDA has started accepting submission in eCTD format

Following the same all initial marketing authorization submission from 01.03.2019, need to be submit in Jo-eCTD format. For other submission types an announcement will be published later (a Baseline for already approved marketing authorisations will be required)

Jordan (JO eCTD) Module 1 eCTD Specification current version 1.0.2.

Please visit JFDA’s website at http://www.jfda.jo for the further reference.

ESG upgraded its Pre-Production WebTrader application

ESG upgraded its Pre-Production WebTrader application to 2.0 version, which is also known as Phase 2 release.

Upcoming ESG 2.0 – Phase 2 Release
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EU Module 1 eCTD Specification

The EU Module 1 eCTD Specification has been subsequently updated from version 3.0.1 to version 3.0.2 respectively.

The following aspects are addressed:
1. Due to an update of the EMA procedural guidance regarding documents displaying tracked changes in PDF format inside an eCTD sequence the following sentence was deleted:
“An exception to this rule is in the provision of either product labelling or risk management plan documentation in the Centralised Procedure, where the tracked changes version of the document in PDF format should be placed inside the eCTD, alongside the clean, non‐tracked version.”
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South Africa: MCC releases updated Module 1 eCTD specification and validation criteria

The MCC of South Africa has released updated versions of Module 1 eCTD specification and validation criteria (version 2.0 and 2.1 respectively).
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