The cosmetic industry needs to substantiate their claims as serious breaches of Regulation (EC) No 1223/2009 could be costly. In our last blog on Cosmetic Claims Management we discussed cosmetic claims and the impact of not being compliant to Regulation (EC) No 1223/2009. A Cosmetic Claims Management System might answer in real time many of …
Author Archives: Olaf Schoepke
Cosmetic Claims Management
Don’t take it lightly: Fines for serious breaches of Regulation (EC) No 1223/2009 on cosmetic products could be astronomical! Similar to the pharmaceutical industry, the cosmetic industry is regulated, one aspect being cosmetic claims. Where in the pharmaceutical industry an indication describes a medical condition that a medicinal product is used for, in a similar …
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. …
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Veterinary Medicinal Products – VNeeS changes are coming
The EMA recently released a draft version 3.0 of the VNeesS specification for the provision of electronic submissions for veterinary medicinal products in the EU. Although more updates are expected, the EMA states that the basic folder structures of the draft specification are not subject to further changes. But what have Marketing Authorisation Holders (MAHs) …
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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: …
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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 …
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Subsequent Recognition Procedure: A new kid on the block?
In Europe, Marketing Authorisation Applications (MAAs) can be submitted following different procedures. If Marketing Authorisation Holders (MAHs) desire access to all member of the European Economic Area (EEA) using a single procedure, the Centralised Procedure (CP) is the way to go. The EEA includes the members of the European Union plus Norway, Iceland and Lichtenstein. …
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Digital Transformation for the benefit of the equine world
Digital transformation (DX) is the adaptation of digital technology, the transformation of services and business processes to replace manual or outdated non-digital processes. However, DX is much more than the integration of digital technology. DX might even move technology and processes to the edge of what is currently possible, the last mile where technologies meets, …
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Transitional arrangements for Regulation (EU) 2019/6 for Veterinary Medicinal Products
On 19/July/2021 the CMDv released document EMA/CMDv/181154/2021 entitled “Transitional arrangements for the entry into application of Regulation (EU) 2019/6 for veterinary medicinal products registered under national, mutual recognition and decentralised procedures”. CMDv has prepared this document to assist Marketing Authorisation Holders (MAHs) as well as National Competent Authorities (NCAs) in the management of the transition …
Pharma Whisper 