The FDA is moving forward with digitalisation in all areas and the CDER NextGen Portal is a good example. What is the CDER NextGen portal? CDER’s NextGen Portal is a cloud based system for users to report information to the FDA. From Drug Development Tools (DDTs) to amendment submissions, stakeholders can utilise the NextGen Portal. …
Category Archives: Pharmaceutical
Article 57 xEVMPD to IDMP/SPOR – Automated Consistency Check
As stated in our previous blog, EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it clear that data quality [in PMS] is dependent on xEVMPD. PMS, the Product Management Service out of the EMA SPOR project builds on the data foundations of the Referential …
Continue reading “Article 57 xEVMPD to IDMP/SPOR – Automated Consistency Check”
Article 57 xEVMPD to IDMP/SPOR: PMS Data Migration
EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it more than clear: data quality [in PMS] is dependent on xEVMPD. In our previous blog on PMS Data Migration we highlighted some of the challenges faced by Marketing Authorisation Holders (MAHs) already and these challenges …
Continue reading “Article 57 xEVMPD to IDMP/SPOR: PMS Data Migration”
Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?
The situation All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from …
Continue reading “Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?”
Medicinal Product Line Outsourcing
Change creates opportunity, they say. Here’s one change that might benefit – if handled right – the medicine originator, the service provider, and foremost the patient by just moving the responsibilities of an entire medicinal product line into different hands. Part I – The Opportunity What opportunity am I talking about, as outsourcing itself is …
Structured Authoring – Streamlining Regulatory Submissions
It still surprises me that in an industry such as life sciences where quality, compliance and accuracy is of utmost importance, data that can be automatically handled is managed manually. Manual data management is prone to errors, is time consuming and is sometimes even a risky approach of dealing with information across different business functions. …
Continue reading “Structured Authoring – Streamlining Regulatory Submissions”
New eCTD rejection criteria in force at the FDA
Marketing Authorisation Holders beware! The FDA has just announced that the Center for Drug Evaluation and Research (CDER) will begin rejecting submissions that fail eCTD validation checks 1551 and 1553. Both validation errors are of high severity as described in the eCTD Validation Criteria specification. The different severity levels can be summarised as follows: High: …
Continue reading “New eCTD rejection criteria in force at the FDA”
FDA eCTD file formats updated
New opportunities for Pharma companies! Now Pharma companies can use audio and video files to support their promotional material during marketing authorisation applications, making the entire process more engaging. Over the last few months, the FDA has updated the file formats that are permitted within the eCTD. New formats have been added to the file …
FDA’s novel excipient pilot program is open for candidates
CDER (Center for Drug Evaluation and Research) recently launched a new voluntary Novel Excipient Review Pilot Program, intended to allow excipient manufacturers to obtain FDA review of certain ‘novel excipients’ prior to their use in medicinal products. This pilot is geared at fostering development of excipients that may be useful in scenarios in which manufacturers …
Continue reading “FDA’s novel excipient pilot program is open for candidates”
FDA Guidance for Industry: Development of Abbreviated New Drug Applications during the COVID-19 Pandemic
In April 2021 the FDA released a new question & answer guidance document for the industry, specifically addressing Generics and their challenges during the COVID-19 pandemic. As the guidance is coming into effect immediately without prior public comments, it is worth having a closer look. The FDA has issued this guidance to provide general recommendations …
Pharma Whisper 