EMA news: pre-submission requests under Reg 2019/6, AMR updates and guidance for vaccine development
The EMA has posted the press release with details of the CVMP's meeting of 16 – 17 February 2021, which includes the following important procedural announcement:
For MA applications with a validation date on or after 28 January 2022, eligibility for the CP should be requested in accordance with Reg. 2019/6 and the correct legal base for the application under 2019/6 should be stated. Until the pre-submission form has been updated, Applicants should follow the more detailed instructions provided in the press release.
Further news from the February plenary meeting and other recent updates from the EMA are summarised below.
Antimicrobials and Resistance (AMR)
- Revised reflection paper on antimicrobial resistance in the environment.
- Revised reflection paper on the 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.
- The “CVMP strategy on antimicrobials 2021-2025” has now been published, together with the overview of comments received during consultation.
Maximum residue limits (MRLs)
A revised draft guideline on safety and residue data requirements for the establishment of maximum residue limits in minor species has been adopted.
Reg. 2019/6 and VMPs intended for Limited Markets
Under Reg. 2019/6, the term "Minor Use and Minor Species" is not used and instead there will be VMPs intended for limited markets. Article 4(29) provides a definition of "limited market" and Article 23(1) provides the conditions to be met in order to be granted limited market status. The CVMP has now adopted further draft guidance on the eligibility criteria and and data requirements for limited market products. The following guidance is now out for consultation:
- Draft reflection paper on classification of a product as intended for a limited market and eligibility for authorisation according to Article 23 (Applications for limited markets)
- Draft guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets and submitted under Article 23 of Regulation (EU) 2019/6
- Draft guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6
- Draft guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6
Also with respect to Reg. 2019/6, Issue 3 of "Veterinary Medicines Regulation highlights" has been published. This issue focuses mostly on developments on the various new union databases (manufacturers and wholesale distributors; product; pharmacovigilance), but also provides an overview of stakeholder views on what they expect to be the biggest impacts of 2019/6.
guidance for vaccines / immunologicals
Following their adoption in the January plenary meeting of the CVMP, the following documents have now been published on the EMA website:
- Draft concept paper for the development of a guideline on data requirements for authorisation of immunological VMPs under exceptional circumstances.
- Draft concept paper for the development of a guideline on data requirements for vaccine antigen master files.
- Draft concept paper for the development of a guideline on data requirements for vaccine platform technology master files.
- Draft concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease.
- Draft concept paper on the provision of field efficacy studies in support of MA applications for IVMPs and on indications for veterinary vaccines.
The EMA has published the latest version of Annex I to the SOP for management of PSURs for centrally authorised VMPs: contact details of NCAs for PSUR submission.
The dossier requirements for submission of MA and MRL applications to the EMA and to members of the CVMP has been updated.
An update version of “On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services” has been issued.