Developments from EMA on CMC, GMP, ERAs, AMR, PV, Brexit and regulatory procedures

Developments from EMA on CMC, GMP, ERAs, AMR, PV, Brexit and regulatory procedures
18 February, 2020

The EMA has posted the press release with details of the CVMP's meeting of 21 – 23 January 2020 (Link). General news relating to regulatory affairs, from the CVMP meeting and other news published by the EMA since the meeting includes the items listed below.

Chemistry Manufacturing and Controls (CMC)

The reflection paper on risk management requirements for elemental impurities in VMPs has been adopted following the close of the public consultation, together with the overview of comments received (Link).

Two new Quality Q & A's have been listed relating to the use of peptones in the manufacture of active substance (Link).

Good Manufacturing Practice (GMP)

A draft “Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders” has been released for public consultation (Link). This paper, concerning human products and VMPs, seeks to clarify what the various responsibilities are and what they mean for MAHs. It also addresses the various legislative provisions which relate to GMP and which concern MAHs.

Environmental Risk Assessment (ERA)

A new Q & A was adopted relating to the guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in VMPs (Link).

Antibiotic Resistance (AMR)

The updated Antimicrobial Advice Ad Hoc Expert Group (AMEG) categorisation of antibiotics has been published, together with the overview of comments received (Link). This takes into account new classes of antibiotics and the need to use antibiotics in animals versus the risk of AMR to public health.

Regulatory Procedures

Updated Q & As have been published: What can be considered as editorial changes and how should they be submitted within variation procedures?


Access has now been granted to pharmacovigilance data contained in the EudraVigilance database, so that members of the public can view suspected adverse event reports for VMPs (Link). At present, the new ADRreports website only includes data relating to centrally authorised products and the EMA announcement clarifies that the events contained in the database are not necessarily related to or caused by the VMP.


The latest news bulletin for small and medium-sized enterprises - Issue 48 has been published, including a section on VMPs, highlighting the most relevant developments from the EMA for the animal health sector (Link)


Following the UK withdrawal from the EU on 31 January 2020, the EMA has made an announcement to clarify the situation, particularly during the transition period (Link). A Q & A document has also been published on what the European authorities are doing to avoid shortages of medicines due to Brexit (Link).

EMA Activity

The EMA has published its annual (2019) veterinary medicines highlights report (Link) and also the latest monthly report on procedures, GLs etc (Link).


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