eCTD, eCTD 4, FDA, IDMP, Medical Devices

2019 FDA Goals: A Christmas Wish List

Image Credit Angie Chapman https://www.flickr.com/photos/angiet-cakefiend/7178335187/in/photolist-bWjQXM-5Nzjum-5Nvcrt-5MeAEL-2ixWd-5NvaLF-CZcM4n-7YXyHM-5eEVdZ-5eEVe6-VRZQJ5-97o4ku-FW4xX-64CNCY-X6HEUo-J3XeKS-5DgNxm-gBhhE5-X6HJ3N-7gZ4bC-5DgMhq-6khfTX-e9C6ZZ-5DcxDx-9HBaiw-nBqP7w-qBzhoK-hJYfj5-aoQA8J-iRdUdr-WTnycN-8UrP3g-7giMG1-XFeizH-8V8zy8-K6Azn-ZatFom-6z6eQG-8aNvz2-79G6Dg-XU8uhv-WntgLm-5LLfFN-SJLA7d-SKt1sH-K6kTf-QQfE51-Ujfch7-asm29b-ei5nx9

RAPS Regulatory Focus reported from the December 11, 2018 CMS/FDA Summit in Washington DC, as to Janet Woodcock’s goals for FDA in 2019. There was a focus on health, opioids, supply chain safety… all the stuff for which we all need the agency to excel, but I’m here for the changes in regulatory approval processes, …

Conferences

Speaker’s Corner: DIA European eDM Conference

Peter Lassoff, Vice President and Head, Global Regulatory Affairs, and Joel Finkle, Associate Director Offering Management for Regulatory Innovation will both be speaking at the Drug Information Association’s eDM 2018 – Clinical and Regulatory Operational Excellence Forum 29-30 November in Barcelona, Spain. They will coincidentally be presenting in the same session, Process Automation, chaired by …

ACUTA, ARIM, eCTD, Switzerland

SwissMedic Updated eCTD Guidance November 2018

On November 1, SwissMedic, the regulatory agency for Switzerland, updated their guidance for eCTD, including a new version 1.4 of the Data Type Definition (DTD), and validation rules. This corresponds to the recent Revision 4 of the Therapeutic Product Ordinances (HMV4). These rules area available starting January 1, to become mandatory in June. If you …

ARIM, ARIM Publisher, Australia, eCTD, RIM+

Australia Proposing Mandatory eCTD starting 2019

In late October 2018, Australia’s Therapeutic Goods Administration (TGA) opened consultation regarding their proposed schedule to make eCTD mandatory for prescription drug dossier submissions. The full proposal document can be found at the link above.

APT, ARCS, ARID, ARIM, Conferences

Speaker’s Corner, 4Q 2018

Joel Finkle will be speaking at the Drug Information Association (DIA) eDM 2018 – Clinical and Regulatory Operational Excellence Forum in Barcelona Spain, November 29-30, 2018. He will be speaking on the intersection of Component-Based Authoring (CBA) and Regulatory Information Management (RIM), in a presentation titled, “All the Way Around the RIM: From Registration Data …

ARIM, Software Release, Uncategorized

ARIM 3.3 Hotfix 1 Released

ACUTA (an IQVIA company) is pleased to announce the release of ARIM version 3.3 Hot Fix 1. This release includes a number of customer-requested updates and fixes. The key improvements are to our support for Veeva Vault repositories The use of Okta authentication has been made a System Setting, permitting it to be set up …

ARCS, ARIM, Canada, Health Canada, Medical Devices

Health Canada Updates Medical Device Submission Format

Canada XML

On August 21, Health Canada announced that they would be adopting the IMDRF “ToC” format for medical device market authorisation requests. As of April 1, 2019, Premarket Applications for Class III and IV devices (which aren’t the same classification as FDA’s Center for Devices and Radiological Health) will need to be in this format, and …

Brexit, Regulatory Update

ACUTA RIM Shots – August 16 Special Brexit Edition

Lots of Brexit-oriented news in recent days that affects the biotech industry. UK/EMA Separation Implementation Period First of all, in March, the EU and UK agreed to an ‘implementation period’ for medicines to give a little more time for the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to  …