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 …

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. …

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is the adaptation of digital technology, the transformation of services and business processes to replace manual or outdated non-digital processes.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, …

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 …

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 …

EMA’s new veterinary product information template

To be able to support the new veterinary regulations coming into effect in January 2022, the EMA updated the product information template that can be accessed here . The new template includes a new section on restrictions on the use of antimicrobials and antiparasitic veterinary products in an attempt to reduce resistance. The other thing …

EMA electronic Product Information (ePI) Consultation

Expert and public comments sought on ePI, open until 31/July/2021. The EMA has opened a public consultation on the draft EU common standard for electronic product information or ePI. The consultation period is open until end of July 2021 so there is little time left to give feedback. Comments should be provided via an online …

EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’

Action required: Pilot started 25/March/2021. In March 2021 the European Commission, together with the EMA and Member States, committed to initiate a pilot to better understand the root causes of deferred market launches for centrally authorised products. The initiative has been launched with the engagement of future Marketing Authorisation Holders (MAHs). The pilot’s overall objective …

Can our four-legged friends help us get out of the COVID-19 pandemic?

Dogs are well known for their abilities to sniff out drugs even when hidden in the most concealed containers. K-9s assist humans worldwide by supporting the visually disadvantaged, hearing impaired and diabetic patients and they are well known to many of us undertaking security checks on airports. In more recent years though dogs are also …

SPC harmonisation: Call for Contribution to the Public Consultation of the Best Practice Guides of the CMDv

Action required: Consultation period for ‘SPC harmonisation’ ends 29/June/2021. The CMDv (Co-Ordination Group for Mutual Recognition and Decentralised Procedure – Veterinary) is seeking feedback on its Best Practice Guides (NPGs) related to the New Veterinary Regulation (NVR), coming into effect on 28/January/2022. The Best Practice Guides have either been newly created or are updated accordingly. …