Artificial Intelligence is enabling businesses all over the world to create new value from their existing data. Data mining is the most common application growing out of this trend. Read More
Yesterday US FDA has published a new guidance “M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Guidance for Industry”. FDA has addressed recommendations for eCTD 4.0. The guidance also provides separate tables describing the recommended granularity for paper and eCTD v3.2.2 submissions, and for paper and eCTD v4 submissions.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Read More
A combination of factors has resulted in the shifting timeline of EMA’s implementation of the IDMP data collection. One factor is the pending relocation of EMA due to Brexit. Additional factors include the experience gained from implementation of RMS and OMS projects and the delivery method of the P&SMS project to engage the stakeholders. The result is that previously communicated milestones are no longer applicable – the publication of the EU Implementation Guides (EU IGs) will not take place in 2018 and industry will not be requested to start submitting the product data in a new format in 2019. Read More
EMA will invite industry stakeholders to begin registering their super users and start using the RMS and OMS from October 2017.
Until the registration begins (October) industry stakeholders can view and search public data as guest users. In case of RMS, guest users can view public lists and for OMS, all content can be viewed. The OMS dictionary (list of organizations with associated physical locations) currently only includes NCA organization data and the dictionary will gradually be expanded with new data. Read More
On June 21, 2017, FDA communicated their intent to ensure that patients are not being priced out of the medicines they need by taking steps to facilitate increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. Read More
While the opinions about the information model for Regulatory Information Management vary and are subject to many discussions, the one thing most agree on is that promise of regulatory information management (RIM) is that of enabling both compliance and efficiency. Read More
On the 20th of June 2017, EMA provided new information to the Industry Change Liaisons as a part of their information cascade.
EMA has formally approved the P&SMS Iteration 1 project covering IDMP compatible authorized Human and Veterinary Products and Substances Management Services and it is underway. Read More
The FDA deadline on NDA, ANDA, BLA and DMF (paper submissions) is less than 4 weeks away. By 5th of May 2017 the FDA requires that all DMFs are to be submitted in the eCTD format via the Electronic Submissions Gateway (ESG). If your DMF is in paper format with FDA, the same submission does not need to be resubmitted in eCTD format. However, as you move forward it is important to make sure your documents are properly prepared (bookmarked, OCR’d, proper orientation) and you can create your baseline DMF submission as eCTD. The DMF in eCTD format mandate applies to amendments, letters of authorization and annual reports. Read More