EMA publishes new guidelines for veterinary medicine stability data

Regulatory

Redazione

-

5 December 2024

EMA publishes new guidelines for veterinary medicine stability data

The European Medicines Agency (EMA) has unveiled a new guideline to standardize stability data requirements for veterinary medicines under European Regulation 2019/6. This comprehensive document aims to clarify the procedures and data necessary for marketing authorization variations and will come into effect on June 1, 2025.

The guideline distinguishes between Variations Not Requiring Assessment (VNRA) and Variations Requiring Assessment (VRA), applying to all veterinary medicines except for biological, immunological, and biotech products. It extends existing CVMP and VICH guidelines to address the unique requirements of veterinary medicines, offering detailed instructions on stability testing for active ingredients and finished products.

Flexibility in approach

While the guideline outlines standard expectations, it acknowledges alternative methods, such as quality-by-design-based approaches, provided they are justified. Testing methodologies like bracketing, matrixing, or accelerated condition testing are also encouraged, following VICH GL45. This new framework is set to streamline the process, ensuring transparency and consistency while maintaining the safety and quality of veterinary medicines.

For further details, visit EMA’s official webpage.

The new FDA Digital Health Advisory Committee

Regulatory

Redazione

-

26 October 2023

0

The new FDA Digital Health Advisory Committee

The strong expansion of new applications of digital technologies in healthcare – including, for example, artificial intelligence and machine learning algorithms, virtual and augmented reality solutions, digital therapies, remote patient monitoring systems, etc. – has prompted the US Food and Drug Administration (FDA) to set up a new Advisory Committee entirely dedicated to the topic of digital health. The Digital Health Advisory Committee, which is expected to become fully operational as of 2024, will be tasked with advising the agency on all aspects of digital technologies in healthcare in order to better understand the risks, benefits, and potential clinical outcomes from them.

The committee will be composed of people from different disciplines and backgrounds with the necessary technical and scientific expertise. The voting core of the committee will consist of nine members, who will be joined by temporary members selected for particular meetings depending on the topics discussed. Among the areas that could be touched by the activities of the newly formed Digital Health Advosory Committee are decentralised clinical trials, patient-generated health data and cybersecurity.

EMA, consultation on single-arm clinical studies

R&D
Trials

Redazione

-

18 May 2023

0

EMA, consultation on single-arm clinical studies

A new reflection paper and a consultation open up to 30 September 2023 will pave the way to the drafting of a new guideline on single-arm clinical trials submitted to EMA as pivotal evidence in support of marketing authorisation (MA) applications.

The reflection paper published by the European Medicines Agency is the first of this type at the international level. It has been adopted by EMA’s CHMP committee with contributions from the CAT Committee, the Methodology Working Party and the Oncology Working Party. The publication of the final document is planned for 2024.

Single-arm clinical trials are used whereas experimentation occurs in therapeutic areas characterised by small target patients populations, i.e. in rare diseases and rare cancers. In such instances, it often result impossible to enrol a sufficient number of patients to run randomised clinical trials. A proportion of the MA applications are thus submitted to EMA with clinical data from single-arm trials as pivotal evidence. These are trials where there is no randomised comparator, all enrolled patients receive the experimental treatment and only the outcomes under the experimental treatment can be observed.

EMA’s reflection paper outlines considerations on single-arm trials submitted as pivotal evidence to demonstrate efficacy in a MA application. Comments collected from the consultation phase will support the drafting of the new guideline.

Source: EMA