EMA news: Implementation of Reg. 2019/6, AMR guidance, GMP, eSubmissions and Big Data
March saw the return of the Veterinary Medicines Info Day, hosted by the EMA and supported by AnimalhealthEurope. For the first time this was a virtual event and over 1000 delegates registered to attend. This level of interest is not surprising considering the huge changes coming in January next year, with Regulation (EU) 2019/6 coming into effect and many of the details of its implementation still to be confirmed.
The Info Day highlighted just how much work there is left to do. While work on the implementation continues, the day to day work of industry and regulators doesn't stop, with ongoing developments in antimicrobial resistance guidance, post-Brexit arrangements, eSubmissions and new challenges with Big Data.
Veterinary medicines Regulation (EU) 2019/6
The EMA pre-submission Q & A's #1 and #2, regarding eligibility for the centralised procedure have been updated and now include instructions for submitting pre-submission requests in accordance with Regulation (EU) 2019/6, with a new request form now available to use.
A draft of the new QRD template has been published for consultation, which addresses the changing requirements introduced under Regulation (EU) 2019/6.
The European Commission has now published the draft delegated act to establish the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans, for which consultation remains open until 23 April 2021.
EMA and cvmp monthly reports
The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 March 2021. There were no updates on guidance documents or general regulatory affairs.
The first of the EMA monthly reports for 2021 is now available online. The end of the report includes a summary of the guidelines and working documents released by the EMA so far in 2021.
A new version of the eSubmission Gateway XML delivery file is now available for veterinary MRL and referral submissions.
The European Medicines Regulatory Network has launched the Digital Application Dataset Integration project (DADI) which follows on from the Common European Single Submission Portal (CESSP) phase 1 project.
Antimicrobial resistance (AMR)
Two reflection papers concerning antimicrobial resistance have been adopted after the close of public consultation:
- Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health.
- Antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products
Veterinary Big Data event
The EMA has announced the first Veterinary Big Data stakeholder forum, set to take place as a virtual event on 1 – 2 June 2021.
Post-Brexit Good Manufacturing Practice (GMP) agreement
The EU-UK Trade and Cooperation Agreement has been concluded and includes a specific annex to cover the recognition of GMP inspection outcomes carried out by EU and UK authorities.