EMA news summary 18Jun18: pharmacovigilance, electronic submissions, MRLs and GMP / GDP

CVMP meeting May 2018 - EudraVigilance update

The EMA has posted the press release with details of the CVMP's meeting of 23 – 25 May 2018 (Link), in which a revised recommendation for the basic surveillance of EVVet data for centrally authorised products was adopted (Link). As stated on the EMA website “The revised recommendation integrates processes for signal detection based on EVVet data and the evaluation of periodic safety update reports”. Further explanation is provided in the press release (Link). For MAHs, implementation of the recommendation is voluntary.

Electronic submissions

Outside of the CVMP meeting, the EMA issued a notice that the latest versions of the electronic application forms (eAFs v1.23) will be released on 13 July 2018, following user testing in June Link).

Maximum Residue Limits (MRLs)

As of May 2018, the last of three measures have been adopted to formalise new rules to replace the current Volume 8 guidance on MRLs (Link). The three measures introduced are as follows:

• Regulation (EU) 2017/12 (Jan 17), changing the structure of the documentation to be included in the MRL application dossier
• Regulation (EU) 2017/880 (May 17), which aims to increase the availability of veterinary medicines
• Regulation (EU) 2018/782 (May 18), describing the methodology to be used in the scientific risk assessment and establishment of risk management recommendations

These new rules replace Volume 8 as of 19 June 2018.

GMP / GDP

The EMA has also published updated Q & A pages regarding Good Manufacturing Practice and Good Distribution Practice (Link).

Summary of EMA activities with Veterinary Medicines

Finally, also published was the “monthly report on application procedures, guidelines and related documents for veterinary medicines” for April (Link), which, amongst other things, summarises the status of guidelines in preparation and adopted in 2018.